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The traditional therapeutic paradigm: Complete denture therapy

Identifieur interne : 005305 ( Istex/Corpus ); précédent : 005304; suivant : 005306

The traditional therapeutic paradigm: Complete denture therapy

Auteurs : Rhonda F. Jacob

Source :

RBID : ISTEX:A5CE143131DECD99EC8DEEA0987839D42F204FB5

English descriptors

Abstract

Abstract: The art and science of complete dentures for oral restoration has been espoused and debated for over a century. A tradition of clinical mentoring has passed this prosthodontic trust through time to create an educational cycle where the pupil ultimately became the tutor for yet another pupil. Today's clinical techniques and judgments are an amalgamation of these original prosthodontic philosophies. This article will bring forward some procedures for the fabrication of complete dentures for the scrutiny of their scientific bases. Scrutiny does not imply that aspects of therapy not proved in studies of rigorous scientific design are untruths. However, it is incumbent that those aspects of denture therapy regarded as “public domain” by the corpus of the profession be analyzed. It is also incumbent that possible costly or harmful aspects of denture therapy be identified. There is a paucity of “procedural research” in clinical investigations; research that involves performing an invasive or clinician-intensive procedure. This article also discusses the difficulties in performing procedural research as a means of understanding its importance, but also realizing the reasons that this type of research is not prevalent in the dental and health professional literature. The most common types of investigations used to evaluate patient acceptance and function of dentures will also be discussed. (J Prosthet Dent 1998;79:6-13.)

Url:
DOI: 10.1016/S0022-3913(98)70186-6

Links to Exploration step

ISTEX:A5CE143131DECD99EC8DEEA0987839D42F204FB5

Le document en format XML

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<title level="j">The Journal of Prosthetic Dentistry</title>
<title level="j" type="abbrev">YMPR</title>
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<p>The art and science of complete dentures for oral restoration has been espoused and debated for over a century. A tradition of clinical mentoring has passed this prosthodontic trust through time to create an educational cycle where the pupil ultimately became the tutor for yet another pupil. Today's clinical techniques and judgments are an amalgamation of these original prosthodontic philosophies. This article will bring forward some procedures for the fabrication of complete dentures for the scrutiny of their scientific bases. Scrutiny does not imply that aspects of therapy not proved in studies of rigorous scientific design are untruths. However, it is incumbent that those aspects of denture therapy regarded as “public domain” by the corpus of the profession be analyzed. It is also incumbent that possible costly or harmful aspects of denture therapy be identified. There is a paucity of “procedural research” in clinical investigations; research that involves performing an invasive or clinician-intensive procedure. This article also discusses the difficulties in performing procedural research as a means of understanding its importance, but also realizing the reasons that this type of research is not prevalent in the dental and health professional literature. The most common types of investigations used to evaluate patient acceptance and function of dentures will also be discussed. (J Prosthet Dent 1998;79:6-13.)</p>
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<aid>86948</aid>
<ce:pii>S0022-3913(98)70186-6</ce:pii>
<ce:doi>10.1016/S0022-3913(98)70186-6</ce:doi>
<ce:copyright type="other" year="1998">Editorial Council of The Journal of Prosthetic Dentistry.</ce:copyright>
</item-info>
<head>
<ce:article-footnote>
<ce:label></ce:label>
<ce:note-para>Reprint requests to: Dr. Rhonda F. Jacob, MD Anderson Cancer Center, Box 69, 1515 Holcombe Blvd., Houston, TX 77030</ce:note-para>
</ce:article-footnote>
<ce:article-footnote>
<ce:label>☆☆</ce:label>
<ce:note-para>
<ce:sup>a</ce:sup>
Associate Professor, Department of Dental Oncology.</ce:note-para>
</ce:article-footnote>
<ce:article-footnote>
<ce:label></ce:label>
<ce:note-para>
<ce:bold>10/1/86948</ce:bold>
</ce:note-para>
</ce:article-footnote>
<ce:title>The traditional therapeutic paradigm: Complete denture therapy</ce:title>
<ce:presented>Presented at the annual meeting of the Academy of Prosthodontics, Halifax, Nova Scotia, Canada, May 1997.</ce:presented>
<ce:author-group>
<ce:author>
<ce:given-name>Rhonda F.</ce:given-name>
<ce:surname>Jacob</ce:surname>
<ce:degrees>DDS, MD
<ce:sup>a</ce:sup>
</ce:degrees>
</ce:author>
<ce:affiliation>
<ce:textfn>University of Texas M. D. Anderson Cancer Center Houston, Texas</ce:textfn>
</ce:affiliation>
</ce:author-group>
<ce:abstract>
<ce:section-title>Abstract</ce:section-title>
<ce:abstract-sec>
<ce:simple-para>The art and science of complete dentures for oral restoration has been espoused and debated for over a century. A tradition of clinical mentoring has passed this prosthodontic trust through time to create an educational cycle where the pupil ultimately became the tutor for yet another pupil. Today's clinical techniques and judgments are an amalgamation of these original prosthodontic philosophies. This article will bring forward some procedures for the fabrication of complete dentures for the scrutiny of their scientific bases. Scrutiny does not imply that aspects of therapy not proved in studies of rigorous scientific design are untruths. However, it is incumbent that those aspects of denture therapy regarded as “public domain” by the corpus of the profession be analyzed. It is also incumbent that possible costly or harmful aspects of denture therapy be identified. There is a paucity of “procedural research” in clinical investigations; research that involves performing an invasive or clinician-intensive procedure. This article also discusses the difficulties in performing procedural research as a means of understanding its importance, but also realizing the reasons that this type of research is not prevalent in the dental and health professional literature. The most common types of investigations used to evaluate patient acceptance and function of dentures will also be discussed. (J Prosthet Dent 1998;79:6-13.)</ce:simple-para>
</ce:abstract-sec>
</ce:abstract>
</head>
<body>
<ce:sections>
<ce:para>Paradigm is the phraseology of the 1990s and is defined as “example” or “model.” This article discusses “the traditional therapeutic model of complete denture therapy.” Our challenge is to examine the “everyday routines” in the prosthodontic treatment model for edentulous patients. Routines that include diagnoses and procedures rendered quickly, skillfully, and almost reflexively. The experienced clinician's diagnostic acumen has been honed to note patients' anatomic variations. These variations ultimately require alterations in treatment techniques. Interestingly, these anatomic variations are so frequently observed, clinicians find making alterations in treatment techniques to be fundamental in the prosthodontic routine.</ce:para>
<ce:para>In comparison with the success of other functional prosthetic replacements, the complete denture has had unparalleled success, offering restoration to millions of people throughout the world. Despite the fact that most patients continue to wear their dentures, many do not. Despite the fact that clinical techniques are meticulously performed, there are patients who find their prostheses only marginally serviceable. Clinicians counsel their patients to lower their expectations and to raise their prosthetic awareness. When problems persist, clinicians order prosthetic surgery for their patients to lower their tissue attachments and to raise their bone level. Clinicians have pictures of the ideal ridge with the ideal tissue attachments etched in their experience. They have confidence that complete denture therapy will be successful for those persons with abundant bone quantity, but become skeptical and have limited success in predicting the therapeutic outcome for patients with severely resorbed residual ridges.</ce:para>
<ce:para>There is little question that the primary treatment alternative for edentulous patients includes complete denture prostheses, but whether these patients will also be advised of the “need” for sulcoplasties, or vestibuloplasties, or whether they will “receive” bone augmentations, visor osteotomies, or even implants, too often depends on in whose office the patients find themselves. Despite the fact that some of these reconstructed patients may have successful outcomes, many continue to have functional problems and surgically related morbidities. There is no specific treatment modality that will ensure success. Clinicians and patients are forced to admit that dentures are not a substitute for teeth, rather they are our best solution for no teeth.</ce:para>
<ce:para>In keeping with the intent of this symposium, a number of succeeding articles will examine our methods of restoring the edentulous patient. The articles will consider treatment methods, treatment successes, and the available scientific evidence to support diagnostic practices and treatment procedures.</ce:para>
<ce:section>
<ce:section-title>How Have We Arrived At The Conventional Denture Paradigm?</ce:section-title>
<ce:para>The art and science of denture therapy has been espoused and debated for almost a century. This paradigm has been repeatedly passed from tutor to pupil, with modifications and amalgamations of various philosophies. The pupil-in-time becomes the tutor and the process continues. One cannot deny that clinical procedures have advanced through keen observation, experience, empiricism, anecdote, artistry, and science. As the publications and lectures from Pound, Silverman, Landa, Lytle, Wright, and Tallgren, to name a few, came on the scene and were grasped by the profession, these observations and teachings became part of the clinical “public domain” of denture therapy. The observations and techniques may have been novel at their inception, but the observations have been repeatedly noted by clinicians and the techniques have been performed countless times. Through these teachings, clinicians have become adept at fabricating dentures that are in harmony with patients' variations in anatomy and variations in mandibular motion exhibited during mastication, deglutition, and speech. Likewise, clinicians have used these time-honored skills to diagnose problems in existing prostheses. These prostheses are frequently in disharmony with the patients' anatomy and physiology of mandibular motion, resulting in impaired comfort and function.</ce:para>
<ce:para>If clinicians scrutinize the literature, they will most likely identify prosthodontic procedures that are not validated by rigid scientific methods. It may be sufficient to understand that some prosthodontic treatment procedures are empirically derived. To abandon those procedures or expend more effort researching them would be counterproductive and deter the prosthodontic community from focusing on treatment questions that would offer more to the science of edentulous rehabilitation.</ce:para>
<ce:para>As an overview, the multiple diagnostic and clinical procedures implemented in denture fabrication and diagnosis of problem dentures are considered. These prosthodontic tenants were originally documented in classic prosthodontic essays written by keen clinical observers. The major arguments for the selection of techniques, materials, and occlusal forms were related to function and preservation of existing structures, primarily preservation of healthy mucosa and bone height. Interestingly, advocates of one treatment philosophy often maintained an identical argument for efficacy and anatomic preservation as those clinicians espousing a diametrically opposed philosophy.</ce:para>
<ce:section>
<ce:section-title>Impressions relate to the basal seat and denture base extensions</ce:section-title>
<ce:para>Maximum tissue coverage is desirable with minimal distortion of the basal tissues, without impingement on mobile frena and muscle attachments.
<ce:cross-refs refid="bib1 bib2 bib3">
<ce:sup>1-3</ce:sup>
</ce:cross-refs>
Extension to the hamular notch and vibrating line affords improved maxillary denture retention. These concepts are generally accepted in the domain of prosthodontic knowledge, but a study by Kapur et al.
<ce:cross-ref refid="bib4">
<ce:sup>4</ce:sup>
</ce:cross-ref>
failed to demonstrate a difference in masticatory performance as a result of denture extensions in patients' in masticatory performance tests. The concepts of making pressure, nonpressure, and selective pressure denture impressions have been described as though they are separate entities, but it is difficult to envision a clinician who can make an impression “that does not embody some of the philosophies of each of the above.”
<ce:cross-ref refid="bib5">
<ce:sup>5</ce:sup>
</ce:cross-ref>
Denture examination of problem prostheses includes examination for over and under extension of borders, no rocking of the base when unilaterally manipulated against the ridge, and no movement of the denture when moved in an anterior/posterior direction.
<ce:cross-refs refid="bib6 bib7">
<ce:sup>6,7</ce:sup>
</ce:cross-refs>
</ce:para>
</ce:section>
<ce:section>
<ce:section-title>Establishing maxillomandibular relationship records considers the vertical dimension of occlusion</ce:section-title>
<ce:para>Methods to establish the vertical dimension of occlusion include the swallowing technique,
<ce:cross-refs refid="bib7 bib8">
<ce:sup>7,8</ce:sup>
</ce:cross-refs>
closest speaking space,
<ce:cross-ref refid="bib9">
<ce:sup>9</ce:sup>
</ce:cross-ref>
ridge parallelism, and examination of facial contours at rest position and centric occlusion position.
<ce:cross-refs refid="bib7 bib10 bib11 bib12 bib13 bib14">
<ce:sup>7,10-14</ce:sup>
</ce:cross-refs>
When examining problem dentures, these same techniques are used to determine whether existing dentures are at the appropriate vertical dimension of occlusion.</ce:para>
<ce:para>Anterior tooth position and selection is established by examining facial contours, closest speaking space, F and V position at the vermillion margin of the lip, and esthetics.
<ce:cross-refs refid="bib7 bib9">
<ce:sup>7,9</ce:sup>
</ce:cross-refs>
Posterior tooth position can be established by a selection of a neutral position of the mandibular buccal and lingual tissues or placement of the teeth over the crest of the mandibular alveolar ridge to favor mandibular denture stability.
<ce:cross-refs refid="bib9 bib15">
<ce:sup>9,15</ce:sup>
</ce:cross-refs>
The plane of occlusion is often established by an amalgamation of anatomic landmarks by using the retromolar trigone,
<ce:cross-ref refid="bib16">
<ce:sup>16</ce:sup>
</ce:cross-ref>
lateral border of the tongue, lip commissures,
<ce:cross-ref refid="bib16">
<ce:sup>16</ce:sup>
</ce:cross-ref>
and ridge parallelism. These guidelines came from the examination of the natural dentition, and have not necessarily been researched as to their effect on denture function. Kapur and Soman
<ce:cross-ref refid="bib17">
<ce:sup>17</ce:sup>
</ce:cross-ref>
studied tooth positions in 12 denture wearers, considering various buccolingual and superoinferior positions and found better masticatory performance with teeth positioned over the ridge, at the height of the natural mandibular canine position, and parallel to the ridge. Teeth positioned buccal to the ridge crest produced significant reductions in chewing efficiency.</ce:para>
<ce:para>Many tooth forms have been used throughout the years, but they have given way to either cusp or cuspless forms. Most evaluations considered a small number of subjects who were asked to choose from various tooth forms.
<ce:cross-refs refid="bib18 bib19 bib20 bib21 bib22 bib23">
<ce:sup>18-23</ce:sup>
</ce:cross-refs>
The choices of the patients, their ability to masticate test foods, and even the patients' awareness of the differences in the tooth forms were varied and often inexplicable.</ce:para>
<ce:para>Today's prosthodontic domain related to occlusal schemes includes cuspal teeth arranged in a balanced occlusion and cuspless teeth arranged in a “flat plane,” with simultaneous contact in centric relation occlusion, usually without any attempt to balance the denture teeth in eccentric movements.
<ce:cross-refs refid="bib7 bib24">
<ce:sup>7,24</ce:sup>
</ce:cross-refs>
There are clinicians who use anterior vertical overlap when the horizontal overlap is not sufficient to prevent occlusal disharmonies in speech and mastication. Others balance this anterior vertical overlap with a posterior protrusive contact. When examining existing dentures, similar guidelines for tooth position are considered.</ce:para>
</ce:section>
<ce:section>
<ce:section-title>Centric relation occlusion position</ce:section-title>
<ce:para>The most common techniques for positioning the mandible into centric relation occlusion position include the clinician exerting thumb pressure against the chin, posterior curling of the patient's tongue, or use of a central-bearing-point device
<ce:cross-refs refid="bib7 bib25 bib26 bib27">
<ce:sup>.7,25-27</ce:sup>
</ce:cross-refs>
Reproducibility of the record has been the primary means of judging the accuracy of a technique. The most common recording medium is wax. Yurkstas and Kapur
<ce:cross-ref refid="bib26">
<ce:sup>26</ce:sup>
</ce:cross-ref>
demonstrated (even in a small number of study subjects) that technical differences in the manipulation of the wax recording medium and central-bearing device lead to statistically significant differences in the three-dimensional repeatability of the various wax and central-bearing-point techniques. Michman and Langer
<ce:cross-ref refid="bib8">
<ce:sup>8</ce:sup>
</ce:cross-ref>
examined three methods of obtaining edentulous centric relation occlusion records (wax medium or central-bearing device between wax occlusion rims, or wax medium between maxillary teeth and mandibular wax rim with anterior teeth) in three consecutive case series of group subjects numbering between 123 and 179. The groups were treated by dental students and faculty, with one faculty making visual inspection of the final prostheses to determine the “success” of achieving the correct centric relation position. Within the definition of success, there was a statistically significant positive difference in the accuracy of the record made when teeth were positioned on the trial base.
<ce:cross-ref refid="bib8">
<ce:sup>8</ce:sup>
</ce:cross-ref>
Clinicians have learned, however, through continued clinical use of the various centric relation position techniques that, barring extreme misuse of the techniques, the variations in wax manipulations and positioning of the central-bearing-devices do not equate to a clinically significant difference. Multiple, less commonly used techniques have been cited with the Boos Bitmeter,
<ce:cross-ref refid="bib28">
<ce:sup>28</ce:sup>
</ce:cross-ref>
Shanahan's
<ce:cross-ref refid="bib29">
<ce:sup>29</ce:sup>
</ce:cross-ref>
wax cones, cephalometric radiographs, and so forth. Sears
<ce:cross-ref refid="bib30">
<ce:sup>30</ce:sup>
</ce:cross-ref>
wrote, “the problem of centric relation position has confused a great number of readers, which is not surprising, as many of the writers are also confused.” Examination of the serviceability of existing dentures usually includes a clinical assessment of centric relation occlusion without using a mechanical device.</ce:para>
</ce:section>
<ce:section>
<ce:section-title>Final denture contours</ce:section-title>
<ce:para>Final denture contours should allow adequate tongue space in the maxillary and mandibular denture
<ce:cross-refs refid="bib31 bib32">
<ce:sup>31,32</ce:sup>
</ce:cross-refs>
and have appropriate palatal contours to enhance speech.
<ce:cross-refs refid="bib33 bib34 bib35">
<ce:sup>33-35</ce:sup>
</ce:cross-refs>
The buccal contours should enhance facial contours and allow the buccinator muscles to function within the concavity of the denture flanges.
<ce:cross-refs refid="bib36 bib37">
<ce:sup>36,37</ce:sup>
</ce:cross-refs>
</ce:para>
<ce:para>In addition to routine prosthodontic procedures, clinicians have used various surgical procedures to enhance denture stability. The most common soft tissue surgery is the split-thickness skin graft vestibuloplasty. A 90% satisfaction rate in 152 subjects
<ce:cross-ref refid="bib38">
<ce:sup>38</ce:sup>
</ce:cross-ref>
and 77% improvement in function in 97 subjects
<ce:cross-ref refid="bib39">
<ce:sup>39</ce:sup>
</ce:cross-ref>
was observed after vestibuloplasty. This latter case series described a mental nerve sensibility complication rate from 16% to 56%, depending on the technique of nerve dissection. The other case series described only a 10% satisfaction rate for patients with less than 20 mm of residual mandibular bone height.
<ce:cross-ref refid="bib38">
<ce:sup>38</ce:sup>
</ce:cross-ref>
A review article examined 14 case series, totaling 727 patients who received vestibuloplasty, for patient acceptance and mental nerve disturbances. Satisfaction ranged from 57% to 90% (average patient satisfaction, 80%) and changes in lip sensation ranged from 5% to 39% (average disturbance, 25%).
<ce:cross-ref refid="bib40">
<ce:sup>40</ce:sup>
</ce:cross-ref>
A 5-year follow-up on 30 patients who received vestibuloplasty revealed a 1 mm resorption of bone the first year, which compares favorably with Tallgren's
<ce:cross-ref refid="bib42">
<ce:sup>42</ce:sup>
</ce:cross-ref>
data of 20 postextraction patients with 6 mm of resorption the first 3 years, followed by 0.3 mm of resorption over the next 25 years. The conclusions from this consensus, proceedings based on case series of surgeries for the atrophic mandible, were that resorption of bone after procedures can range from 40% to 50% bone loss in the first few years, followed by a fairly normal bone resorption pattern after augmentation. Variations on the visor osteotomy (with or without interpositional bone grafts) and various onlay procedures were included.
<ce:cross-ref refid="bib43">
<ce:sup>43</ce:sup>
</ce:cross-ref>
In a review article considering that complications of ridge augmentation, the complications related to the alveolar nerve were “unacceptably high” and were reported as being between 40% and 85% in four large case series.
<ce:cross-ref refid="bib44">
<ce:sup>44</ce:sup>
</ce:cross-ref>
No controlled trials comparing various augmentation procedures were performed, but the large case series revealed that overall bone resorption and sensory disturbances must be considered when comparing these treatment modalities to other modalities that may improve denture function.</ce:para>
<ce:para>The use of various denture techniques for the purpose of maintaining alveolar bone has not been successfully proven in the literature. Authors
<ce:cross-refs refid="bib45 bib46">
<ce:sup>45,46</ce:sup>
</ce:cross-refs>
have recognized for some time that the mode of bone resorption in the maxilla and mandible is multifactorial, and has great individual variation. Tallgren,
<ce:cross-refs refid="bib47 bib47">
<ce:sup>47,48</ce:sup>
</ce:cross-refs>
Carlsson,
<ce:cross-refs refid="bib49 bib50">
<ce:sup>49,50</ce:sup>
</ce:cross-refs>
and Atwood
<ce:cross-ref refid="bib51">
<ce:sup>51</ce:sup>
</ce:cross-ref>
have shown that bone resorption is marked immediately after dental extractions, but the rate slows with time. A series of patients being treated with “complex” and “simple” denture techniques, followed with cephalometric radiographs for 5 years, did not reveal a difference between the two groups in relation to bone loss.
<ce:cross-ref refid="bib52">
<ce:sup>52</ce:sup>
</ce:cross-ref>
</ce:para>
</ce:section>
</ce:section>
<ce:section>
<ce:section-title>Scientific Evidence: Research Design and Measurement Tools</ce:section-title>
<ce:para>Let us consider the charge of this symposium. As briefly enumerated in the overview, there are a myriad of thought processes and multiple procedures involved in making complete dentures. The multiple patient variations in anatomic contours and functional movements necessitate alterations in clinical procedures and add to the complexity of these procedures and the complexity of evaluating their efficacy.</ce:para>
<ce:para>What is the strength of the scientific evidence that supports these prosthodontic tenants in the denture paradigm? This article discusses two criteria related to the strength of scientific evidence: (1) characteristics of the research design and (2) characteristics of the tools used to measure success.</ce:para>
<ce:section>
<ce:section-title>Research design</ce:section-title>
<ce:para>There are three means for a clinician to make decisions concerning a treatment process.
<ce:cross-ref refid="bib53">
<ce:sup>53</ce:sup>
</ce:cross-ref>
The ideal decision-making process is deduction: Where the clinician examines the facts from available studies that (1) are properly designed prospective, randomized clinical trials, (2) are properly designed, large epidemiologic studies that consider the efficacy of a well-accepted and well-researched treatment modality, (3) include a patient population similar to that of the patient in question, (4) include the appropriate number of study subjects, and (5) reach a definitive conclusion. The concept of appropriate numbers and definitive conclusions go hand in hand; a statistically significant, definitive conclusion cannot be reached if there are not enough study participants. Even if there is a difference between the outcomes of two populations receiving two treatments, without enough patients in the study the results will not reveal a statistical difference. Likewise, if there are not enough patients in the study, one cannot be certain of the correctness of a trial that finds no difference between two treatment modalities. Deduction is the most concrete and ideal means of making treatment decisions.</ce:para>
<ce:para>The second decision-making process involves induction: Where the clinician considers therapies that “ought to work” based on his or her own clinical experience or by taking an educated “leap of faith” to extend current concepts of treatment beyond what has been proved. Studies considered in this realm (1) are retrospective in nature, (2) may be prospective in nature but involve a different patient population than the patient in question, (3) may use related but not identical materials or techniques than those being considered by the clinician, (4) have limited patient numbers such that a definitive conclusion was not reached, but there may have been a “trend of the data” toward a difference in the two population outcomes, or (5) may have used nonrandomized treatment selection, with the patients being assigned or self-selecting their treatment. This latter patient selection process allows biases in patient selection. When this occurs, there is limited possibility that the two test populations will be similar.</ce:para>
<ce:para>Having discussed deduction and induction, the third decision-making process is termed seduction: Where the clinician plans treatment based on conversations with colleagues, manufacturers' advertisements, testimonials, case reports, and limited case series with minimal follow-up and vague inclusion/exclusion criteria for patient selection.</ce:para>
<ce:para>There is a paucity of deductive decision making in the health profession, be it in dentistry, nursing, or medicine. It is not because clinicians do not wish to deliver the best possible therapy, but it is primarily due to a paucity of excellent research. When the clinical trial requires caregivers to perform invasive procedures to achieve a particular outcome, as opposed to administer medication, the research design often suffers. One can imagine that researchers can blind the patient and a practitioner to a medication, but blinding a patient and an examiner to a bone graft, vestibuloplasty, or an implant becomes impossible. Standardizing a multiclinician, multistep clinical, or surgical procedure is much more difficult than standardizing a drug regimen. Patients are more reluctant about being randomized to different invasive procedures than they are about being randomized to different drug regimens. This is especially true when crossover drug trials can be designed that allow the subjects to receive both drugs at different time periods within the same study. This design requires fewer patient numbers, and calms patients' misgivings that they might be missing out on a particular treatment opportunity. However, in invasive clinical trials, the anatomic structures may be altered with the first procedure, such that the second crossover procedure is not possible. In a recent implant investigation, a crossover trial allowed two procedures to be performed on the study patients.
<ce:cross-refs refid="bib54 bib55">
<ce:sup>54,55</ce:sup>
</ce:cross-refs>
This crossover was possible as one prosthesis used four to five implants in a totally implant-supported mandibular overdenture, compared with a second prostheses that used four to five implants to support a fixed-hybrid mandibular prosthesis. This statistically significant study revealed that there are patients who are willing to sacrifice the concept of a fixed prostheses being a “part of me,” as opposed to a removable prostheses that retains the stigma of being “false” to maintain ease of cleaning their mouths. This implant overdenture design did not have any mucosal contact in these patients, therefore it would be an improper inductive reasoning process to extrapolate these statistically significant results to “
<ce:sup>2</ce:sup>
implant/tissue-supported mandibular overdentures.”</ce:para>
<ce:para>When considering invasive procedural trials, patients also are more apt to have a preconceived notion about their outcome, side effects, and morbidities when being asked to consent to randomization. In fact, some patients may want the more invasive procedure, because they perceive it as more “curing,” whereas others will want the more technically advanced procedure for the same reason. With this preconceived patient bias, it is often difficult to accrue patients to randomized trials.</ce:para>
<ce:para>Another difficulty in designing randomized clinical trials that involve procedures and techniques is that large patient numbers are required to answer clinical outcomes. There are many variables within the patient population, within the complex procedures, and within the skills of the clinicians that can produce considerable variation in the investigation. Also, there may be significant but small differences between the treatments being investigated. Large variations in the study and small differences between treatments equate to the need for large patient numbers in the investigation to reach a definitive conclusion. In life and death medical situations, and those situations with extreme effects on quality of life (for instance loss of eye sight or loss of hearing), clinicians will embark on studies to prove differences of as little as 10% between treatments. This small difference can require several hundreds of patients to reveal a definitive conclusion. When considering complete denture therapy, it may be decided a 10% clinical difference between two impression materials makes for a moot investigation. This is especially true when considering that patient's denture-bearing tissues are displaceable, processing changes occur in the acrylic resins, and there is the availability of pressure indicator paste. Time and money for prosthodontic research may be better spent investigating a question with a better clinical payoff.</ce:para>
<ce:para>Given the large number of patients needed for clinical trials, it is often impossible for one institution, and certainly one practitioner, to recruit enough patients to complete an investigation. For this reason, multi-institutional studies are often required to answer a clinical question. Organizing a multi-institutional trial, investigating a multistep procedure, and employing clinicians of variable skill levels and biases about the test procedures is a monumental research task. Our internal medicine colleagues who prescribe medications are more apt to achieve their research goals than are we “invasive/procedural health care professionals.”</ce:para>
<ce:para>Another reason for the small patient numbers found in investigative clinical trials of procedures and techniques is high research costs. Procedures that are labor intensive, require special equipment, or require special personnel can escalate a research budget to nonfundable proportions. It is also difficult to persuade patients to agree to pay for an experimental treatment. If patients must pay for treatment, they want to be assured that they will receive the treatment they desire. For instance, patients may be willing to assume the costs of their therapy if they can be assured that they will receive assignment to the dental implant arm of the study. They may not be willing to pay if they are assigned to the complete denture arm of the study. However, if they can get either treatment for free, they might be willing to take their chances with randomization. Geertman et al.
<ce:cross-refs refid="bib56 bib57">
<ce:sup>56,57</ce:sup>
</ce:cross-refs>
randomized patients in a two-center clinical trial to implant either retained mandibular overdentures or complete dentures. Despite patients agreeing to the investigation and signing an informed consent that confirmed they would receive assignment to one of the two treatments in a randomized fashion, Geertman et al.
<ce:cross-refs refid="bib56 bib57">
<ce:sup>56,57</ce:sup>
</ce:cross-refs>
still had subjects refuse to begin any therapy because they were not assigned to the group they preferred. There were those patients who were afraid of surgery and therefore did not want implants, and there were those patients who believed their long-standing denture problems could not be cured with another denture.
<ce:cross-refs refid="bib56 bib57 bib58">
<ce:sup>56-58</ce:sup>
</ce:cross-refs>
</ce:para>
<ce:para>There are also strong clinician biases that the procedures we perform with arduous care are the procedures that offer the best cure, and those we do not (or cannot) perform are inferior. Yes, even dentists have a minor deity complex. There is a very strong clinician bias against randomization of patients to therapies the clinician does not perform. Similarly, procedural clinicians do not like to have their therapies and outcomes critically examined. They do not portray the same visceral reaction when it is a pill being scrutinized for the cure, rather than a procedure performed by their own hands.</ce:para>
<ce:para>For all the aforementioned reasons, large randomized clinical trials have not permeated the dental or medical literature. What are more prevalent are some well-designed studies with too small a number of subjects to arrive at a definitive conclusion. Or there are studies with patients assigned to various treatments based on the clinicians' or patients' desires, or based on the philosophy of the treating institution. These latter studies may have the data gathered in a prospective fashion, the clinicians may meticulously perform the procedures, but unfortunately these studies are only well-documented case series and cannot be used to make comparative, deductive treatment decisions. Hence, invasive/procedural research is a complex issue from a social, economic, and science aspect. This is why dentistry and a large part of surgical medicine has had to rely on more inductive type of decision-making processes.</ce:para>
</ce:section>
<ce:section>
<ce:section-title>Measurement tools</ce:section-title>
<ce:para>The second criteria for evaluating the strength of scientific evidence relates to the tools used to measure success. How do we judge our success in the treatment of the denture patient? Certainly, the busy clinician's success story is the patient who keeps every appointment, takes the exact allotted time in the schedule for each appointment, requires only one try-in visit, leaves with a smile on his or her face, and returns for only one postinsertion adjustment. This is certainly a simplified representation, but in this scenario, most clinicians would think they scored a treatment success.</ce:para>
<ce:para>Perhaps the questions should be: How do our patients judge treatment success, and what are the research tools that measure success? The most common outcome measurements have involved mastication of food items and patient satisfaction questionnaires. Measuring masticatory performance has included assessments of swallowing thresholds (usually particle size assessment of known food volumes), number of chewing strokes, chewing time, and electromyographic data collected during mastication. The use of patient questionnaires assessing variables related to food eaten, comfort, esthetics, speech, retention, denture security, and overall satisfaction have been used. Innumerable variations on these questions are seen in the literature and innumerable variations on the swallowing thresholds and masticatory performances have been used since Manly
<ce:cross-refs refid="bib59 bib60">
<ce:sup>59,60</ce:sup>
</ce:cross-refs>
and Kapur
<ce:cross-ref refid="bib61">
<ce:sup>61</ce:sup>
</ce:cross-ref>
et al. first reported these tests. The tests tend to be quite objective and reproducible and, in a few instances, have resulted in statistically significant differences in mastication of different foods comparing different prostheses designs and techniques, and in some studies, they have not resulted in any differences. These test methods have often not correlated with patient-based assessments of their chewing ability of different foods, and the masticatory performance tests have not correlated well with the patients' overall prosthesis satisfaction. It appears there is not a laboratory test for denture function that can predict routine patient function and denture satisfaction. As clinicians, we may be placing too much emphasis on comminution. A particular magnitude of particle size may not be relevant to the enjoyment of eating. Other studies have demonstrated that patients have altered their food choices when using dentures. The patients may be satisfied with their denture function because they have lowered their expectations of satisfaction, because of the testimonials of friends and relatives in regard to the need for altered dietary habits. Most patients have also received extensive clinical counseling from their dentists, stating that the patients should expect some changes in their dietary choices and habits.
<ce:cross-refs refid="bib62 bib63">
<ce:sup>62,63</ce:sup>
</ce:cross-refs>
Likewise, these masticatory tests have not proven that specific denture modifications or techniques greatly influence masticatory performance.
<ce:cross-refs refid="bib6 bib64 bib65 bib66 bib67 bib68 bib69 bib70">
<ce:sup>6,64-70</ce:sup>
</ce:cross-refs>
Despite the discrepancies in the available research, there have been no discrepancies in the conclusions that (1) denture patients do not have the chewing ability or masticatory performance of persons with complete dentition, and (2) there is great individual variation in chewing patterns and masticatory performances in complete denture patients.</ce:para>
<ce:para>There has been resurgence in the evaluation of complete dentures, as a control population compared with implant-supported prostheses and preprosthetic surgery for the edentulous patient.
<ce:cross-refs refid="bib56 bib57 bib58 bib71 bib72 bib73 bib74">
<ce:sup>56-58,71-74</ce:sup>
</ce:cross-refs>
Clinicians gathered data on (a) patient-perceived satisfaction and function, and (b) investigator-designed masticatory performance tests. Some of these studies were randomized controlled trials, and some were self- or investigator-selected patient assignments. However, in all these studies, the patients were categorized as having negative denture wearing experiences before entering any studies. In all investigations, the implant-retained or implant-supported groups were more functionally satisfied than the complete denture groups. Validated questionnaires with sophisticated statistical analysis have been used by clinicians in the Netherlands and England.
<ce:cross-refs refid="bib75 bib76 bib77">
<ce:sup>75-77</ce:sup>
</ce:cross-refs>
It has been recognized in these studies, that there is a multifactorial influence of patient and treatment variables (age, gender, medical and mental condition, bone quality and quantity, type of restoration, number of implants, and opposing restorations). It has been recognized that there is a multifactorial influence of patient satisfaction variables (choice of food items, speech, denture security, comfort, and retention). It has been recognized that psychologic patient parameters are evident and must be considered in the complex data gathering and statistical analysis of these studies.
<ce:cross-refs refid="bib75 bib76 bib77 bib78 bib79">
<ce:sup>75-79</ce:sup>
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What is also evident is the imperative need for studies with large numbers of subjects; multi-institutional, multidisciplinary, and multiclinician involvement; and sophisticated statistical assistance.</ce:para>
</ce:section>
</ce:section>
<ce:section>
<ce:section-title>Conclusion</ce:section-title>
<ce:para>The charge of this symposium is to evaluate the prosthodontic literature and research related to treating the edentulous patient. As clinicians, we should be insightful and contemplate future research and treatment opportunities. We should not be paralyzed by the present scarcity of deduction in our daily decision-making processes, because the reality is that patients are waiting to be treated. Treatment decisions must be made with the best available evidence that exists. As we look to the future of our profession and the obligation we have to deliver the ultimate in patient care, we should bear this in mind. As clinicians, we may be satisfied with inductive decision making. At least some of the time, our decisions will be the correct ones, even though research has yet to prove them correct. But if and when we become the patient, our point of reference might change; then perhaps we would want the treating practitioner to be making treatment decisions based on definitive, scientifically sound research.</ce:para>
</ce:section>
</ce:sections>
</body>
<tail>
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<title>The traditional therapeutic paradigm: Complete denture therapy</title>
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<title>The traditional therapeutic paradigm: Complete denture therapy</title>
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<namePart type="given">Rhonda F.</namePart>
<namePart type="family">Jacob</namePart>
<namePart type="termsOfAddress">DDS, MDa</namePart>
<affiliation>University of Texas M. D. Anderson Cancer Center Houston, Texas</affiliation>
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<abstract lang="en">Abstract: The art and science of complete dentures for oral restoration has been espoused and debated for over a century. A tradition of clinical mentoring has passed this prosthodontic trust through time to create an educational cycle where the pupil ultimately became the tutor for yet another pupil. Today's clinical techniques and judgments are an amalgamation of these original prosthodontic philosophies. This article will bring forward some procedures for the fabrication of complete dentures for the scrutiny of their scientific bases. Scrutiny does not imply that aspects of therapy not proved in studies of rigorous scientific design are untruths. However, it is incumbent that those aspects of denture therapy regarded as “public domain” by the corpus of the profession be analyzed. It is also incumbent that possible costly or harmful aspects of denture therapy be identified. There is a paucity of “procedural research” in clinical investigations; research that involves performing an invasive or clinician-intensive procedure. This article also discusses the difficulties in performing procedural research as a means of understanding its importance, but also realizing the reasons that this type of research is not prevalent in the dental and health professional literature. The most common types of investigations used to evaluate patient acceptance and function of dentures will also be discussed. (J Prosthet Dent 1998;79:6-13.)</abstract>
<note>Reprint requests to: Dr. Rhonda F. Jacob, MD Anderson Cancer Center, Box 69, 1515 Holcombe Blvd., Houston, TX 77030</note>
<note>aAssociate Professor, Department of Dental Oncology.</note>
<note>10/1/86948</note>
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