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<title xml:lang="en">Evaluation of satisfaction of individuals rehabilitated with zygomatic implants as regards anesthetic and sedative procedure: A prospective cohort study</title>
<author>
<name sortKey="Almeida, Paulo H T" sort="Almeida, Paulo H T" uniqKey="Almeida P" first="Paulo H. T." last="Almeida">Paulo H. T. Almeida</name>
</author>
<author>
<name sortKey="Salvoni, Alexander D Alvia" sort="Salvoni, Alexander D Alvia" uniqKey="Salvoni A" first="Alexander D'Alvia" last="Salvoni">Alexander D'Alvia Salvoni</name>
</author>
<author>
<name sortKey="Franca, Fabiana M G" sort="Franca, Fabiana M G" uniqKey="Franca F" first="Fabiana M. G." last="França">Fabiana M. G. França</name>
</author>
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<idno type="pmid">28924474</idno>
<idno type="pmc">5591452</idno>
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<idno type="RBID">PMC:5591452</idno>
<idno type="doi">10.1016/j.amsu.2017.08.017</idno>
<date when="2017">2017</date>
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<title xml:lang="en" level="a" type="main">Evaluation of satisfaction of individuals rehabilitated with zygomatic implants as regards anesthetic and sedative procedure: A prospective cohort study</title>
<author>
<name sortKey="Almeida, Paulo H T" sort="Almeida, Paulo H T" uniqKey="Almeida P" first="Paulo H. T." last="Almeida">Paulo H. T. Almeida</name>
</author>
<author>
<name sortKey="Salvoni, Alexander D Alvia" sort="Salvoni, Alexander D Alvia" uniqKey="Salvoni A" first="Alexander D'Alvia" last="Salvoni">Alexander D'Alvia Salvoni</name>
</author>
<author>
<name sortKey="Franca, Fabiana M G" sort="Franca, Fabiana M G" uniqKey="Franca F" first="Fabiana M. G." last="França">Fabiana M. G. França</name>
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<series>
<title level="j">Annals of Medicine and Surgery</title>
<idno type="eISSN">2049-0801</idno>
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<date when="2017">2017</date>
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<front>
<div type="abstract" xml:lang="en">
<sec>
<title>Purpose</title>
<p>To evaluate the satisfaction of individuals with atrophic maxilla, rehabilitated with fixed dental prostheses, anchored on zygomatic implants, with variables being the anesthetic procedure: general anesthesia, or local with sedation.</p>
</sec>
<sec>
<title>Materials and Methods</title>
<p>By means of the clinical record charts from the Training Course in Advanced Hospital Surgeries for Implant Dentists conducted at the Campinas-SP unit of the São Leopoldo Mandic School of Dentistry, 30 individuals were randomly selected. They had zygomatic implant placement surgeries performed, and were rehabilitated with fixed implant supported complete dentures, between the years 2005 and 2011. One group of 15 individuals underwent surgery in hospital, under general anesthesia. The other 15 were treated in the post-graduation clinic at the School of Dentistry, under local anesthesia and sedation.</p>
</sec>
<sec>
<title>Results</title>
<p>From the emotional point of view, the Wilcoxon test revealed that irrespective of the anesthesia procedure used, at the beginning of treatment, the emotional condition of individuals differed from that verified after conclusion of the treatment (p < 0.0001).</p>
</sec>
<sec>
<title>Conclusion</title>
<p>There was no difference between the two groups as regards the anesthetic procedure. General satisfaction was high; there was emotional improvement after conclusion of the treatment, thus improving the quality of life.</p>
</sec>
</div>
</front>
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<pmc article-type="research-article">
<pmc-dir>properties open_access</pmc-dir>
<front>
<journal-meta>
<journal-id journal-id-type="nlm-ta">Ann Med Surg (Lond)</journal-id>
<journal-id journal-id-type="iso-abbrev">Ann Med Surg (Lond)</journal-id>
<journal-title-group>
<journal-title>Annals of Medicine and Surgery</journal-title>
</journal-title-group>
<issn pub-type="epub">2049-0801</issn>
<publisher>
<publisher-name>Elsevier</publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id pub-id-type="pmid">28924474</article-id>
<article-id pub-id-type="pmc">5591452</article-id>
<article-id pub-id-type="publisher-id">S2049-0801(17)30340-0</article-id>
<article-id pub-id-type="doi">10.1016/j.amsu.2017.08.017</article-id>
<article-categories>
<subj-group subj-group-type="heading">
<subject>Original Research</subject>
</subj-group>
</article-categories>
<title-group>
<article-title>Evaluation of satisfaction of individuals rehabilitated with zygomatic implants as regards anesthetic and sedative procedure: A prospective cohort study</article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname>Almeida</surname>
<given-names>Paulo H.T.</given-names>
</name>
<email>dpauloh@ig.com.br</email>
<xref rid="cor1" ref-type="corresp"></xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Salvoni</surname>
<given-names>Alexander D'Alvia</given-names>
</name>
</contrib>
<contrib contrib-type="author">
<name>
<surname>França</surname>
<given-names>Fabiana M.G.</given-names>
</name>
</contrib>
</contrib-group>
<aff id="aff1">Department of Dental Surgery, São Leopoldo Mandic Insitute and Dental Research Center, Campinas, SP, Brazil</aff>
<author-notes>
<corresp id="cor1">
<label></label>
Corresponding author. Department of Dental Surgery, São Leopoldo Mandic Insitute and Dental Research Center, Rua Dr. José Rocha Junqueira, 13, CEP: 13045-755, Campinas, SP, Brazil.Department of Dental SurgerySão Leopoldo Mandic Insitute and Dental Research CenterRua Dr. José Rocha Junqueira, 13CampinasSPCEP: 13045-755Brazil
<email>dpauloh@ig.com.br</email>
</corresp>
</author-notes>
<pub-date pub-type="pmc-release">
<day>01</day>
<month>9</month>
<year>2017</year>
</pub-date>
<pmc-comment> PMC Release delay is 0 months and 0 days and was based on .</pmc-comment>
<pub-date pub-type="collection">
<month>10</month>
<year>2017</year>
</pub-date>
<pub-date pub-type="epub">
<day>01</day>
<month>9</month>
<year>2017</year>
</pub-date>
<volume>22</volume>
<fpage>22</fpage>
<lpage>29</lpage>
<history>
<date date-type="received">
<day>19</day>
<month>4</month>
<year>2017</year>
</date>
<date date-type="rev-recd">
<day>22</day>
<month>8</month>
<year>2017</year>
</date>
<date date-type="accepted">
<day>23</day>
<month>8</month>
<year>2017</year>
</date>
</history>
<permissions>
<copyright-statement>© 2017 The Author(s)</copyright-statement>
<copyright-year>2017</copyright-year>
<license license-type="CC BY-NC-ND" xlink:href="http://creativecommons.org/licenses/by-nc-nd/4.0/">
<license-p>This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).</license-p>
</license>
</permissions>
<abstract id="abs0010">
<sec>
<title>Purpose</title>
<p>To evaluate the satisfaction of individuals with atrophic maxilla, rehabilitated with fixed dental prostheses, anchored on zygomatic implants, with variables being the anesthetic procedure: general anesthesia, or local with sedation.</p>
</sec>
<sec>
<title>Materials and Methods</title>
<p>By means of the clinical record charts from the Training Course in Advanced Hospital Surgeries for Implant Dentists conducted at the Campinas-SP unit of the São Leopoldo Mandic School of Dentistry, 30 individuals were randomly selected. They had zygomatic implant placement surgeries performed, and were rehabilitated with fixed implant supported complete dentures, between the years 2005 and 2011. One group of 15 individuals underwent surgery in hospital, under general anesthesia. The other 15 were treated in the post-graduation clinic at the School of Dentistry, under local anesthesia and sedation.</p>
</sec>
<sec>
<title>Results</title>
<p>From the emotional point of view, the Wilcoxon test revealed that irrespective of the anesthesia procedure used, at the beginning of treatment, the emotional condition of individuals differed from that verified after conclusion of the treatment (p < 0.0001).</p>
</sec>
<sec>
<title>Conclusion</title>
<p>There was no difference between the two groups as regards the anesthetic procedure. General satisfaction was high; there was emotional improvement after conclusion of the treatment, thus improving the quality of life.</p>
</sec>
</abstract>
<abstract abstract-type="author-highlights" id="abs0015">
<title>Highlights</title>
<p>
<list list-type="simple">
<list-item id="u0010">
<label></label>
<p>Wilcoxon test revealed that the emotional condition of the individuals differed at the beginning and end of treatment.</p>
</list-item>
<list-item id="u0015">
<label></label>
<p>General satisfaction with treatment was high.</p>
</list-item>
<list-item id="u0020">
<label></label>
<p>From the emotional point of view of the individuals there was emotional improvement thus improving the quality of life.</p>
</list-item>
</list>
</p>
</abstract>
<kwd-group id="kwrds0010">
<title>Keywords</title>
<kwd>Atrophic maxilla</kwd>
<kwd>Zygomatic implants</kwd>
<kwd>Patient satisfaction</kwd>
<kwd>General anesthesia</kwd>
<kwd>Sedation</kwd>
</kwd-group>
</article-meta>
</front>
<body>
<sec id="sec1">
<label>1</label>
<title>Introduction</title>
<p>Rehabilitating individuals with atrophic maxilla has always been and still is a challenging treatment. Dental surgeons are always concerned about the rehabilitation of these individuals, and over the course of several years, new surgical techniques and dental prostheses have been developed. At present there is a large variety of options for rehabilitating maxillary edentulism. There are patients who wish to have fixed dental prostheses supported by osseointegrated implants. Thus, depending on the degree of superior maxillary atrophy, we may resort to different types of treatments, such as bone grafts, inclined and zygomatic implants.</p>
<p>Frequently, the alveolar ridge resorption is so extensive, that it is not possible to place conventional implants in the posterior region of the maxilla. In these cases, zygomatic implants may be used, either associated with conventional implants in the anterior area, or not
<xref rid="bib1" ref-type="bibr">[1]</xref>
. Initially, zygomatic implants were introduced by professor Branemark
<xref rid="bib2" ref-type="bibr">[2]</xref>
. The surgical procedure was performed in hospital, under general anesthesia, with nasal intubation. Local anesthesia was injected into the maxillary regions and palate. At present, surgery may also be performed in the outpatients' clinic, with local anesthesia
<xref rid="bib3" ref-type="bibr">[3]</xref>
and intravenous
<xref rid="bib3" ref-type="bibr">[3]</xref>
or oral sedation. When searching the literature, there are innumerable studies showing the success of therapy with zygomatic
<xref rid="bib4" ref-type="bibr">[4]</xref>
implants, however, few studies refer to the satisfaction of individuals
<xref rid="bib5" ref-type="bibr">[5]</xref>
,
<xref rid="bib6" ref-type="bibr">[6]</xref>
,
<xref rid="bib7" ref-type="bibr">[7]</xref>
.</p>
<p>The purpose of this research was to evaluate the satisfaction of individuals with regard to the surgical procedure, and in this context, observe the benefits of surgery performed under general or local anesthesia with intravenous or oral sedation. Thus broader knowledge about these subjects would be acquired, to know which procedures were most recommended by both professionals and individuals, for use in future treatments.</p>
</sec>
<sec id="sec2">
<label>2</label>
<title>Materials and Methods</title>
<p>After approval by the Research Ethics Committee (REC) of the São Leopoldo Mandic Dental School, protocol number 2011/0431, this prospective cohort study was conducted with a sample established by convenience. This was composed of 46 clinical record charts of the Department of Dental Surgery, São Leopoldo Mandic Institute and Dental Research Center, of individuals who underwent zygomatic implant placement surgeries. These patients were rehabilitated with fixed implant supported screw-retained dental prostheses (hybrid type), in the years between 2005 and 2011, in the Training Course in Advanced Hospital Surgeries for Implant Dentists conducted at the Campinas-SP unit of the São Leopoldo Mandic School of Dentistry, at the unit in Campinas-SP, Brazil. Of the 46 clinical record charts selected, only 32 individuals were localized after sending letters, e-mails and making telephone calls. Of these individuals, 17 were submitted to surgery in hospital, under general anesthesia, and are here denominated Group 1. The others (fifteen) had surgeries performed at the dental school, in the post-graduate clinic, with local anesthesia and intravenous or oral sedation (Group 2). During surgical planning, the individuals were presented with three options: general anesthesia (performed in hospital); local anesthesia with intravenous sedation (performed in the dental school outpatient clinic); and local anesthesia with oral sedation (also performed in the dental school outpatient clinic). The decision was subject to the complexity of the surgeries (time) and dental surgeon's experience. Seventeen (17) individuals preferred to have the procedure performed in hospital under general anesthesia, when informed that the estimated time of the surgery would be 4 h. Twelve (12) individuals preferred to have the surgery performed at the dental school with local anesthesia and intravenous sedation, under the supervision of an anesthetist doctor; and only 3 individuals underwent the procedure with local anesthesia and oral sedation, when they were informed that the surgical time would be under 1.5 h, and that the surgery would be performed by highly experienced surgeons.</p>
<p>The 32 individual located were contacted by telephone and/or e-mail, to present to the São Leopoldo Mandic dental school, on an appointed day and time, to undergo clinical evaluation. All the individuals of Group 1 had surgeries performed in hospital under general anesthesia. In this group, local infiltrative anesthesia was also administered to contain bleeding in the trans-operative period. In Group 2, 12 individual were submitted to local anesthesia and intravenous sedation (Diazepam 10 mg/Midazolam 10 mg), monitored by an anesthetist doctor, and three received local anesthesia and orally administered sedation (1 tablet of Midazolam 15/mg, 30 min before surgery). In clinical practice, in a surgical time of under 1.5 h, sedation with Midazolam 15 mg has the same effect as that of intravenous sedation, and this was the reason why these patients were included in Group 2). During evaluation, the patients' oral health was examined, and data were collected by means of a personalized questionnaire, associated with a 10 cm long visual analog scale (VAS) (
<xref rid="tbl1" ref-type="table">Table 1</xref>
). The VAS 0 indicated complete dissatisfaction, and 10, complete satisfaction. Similar scales have been used in other studies
<xref rid="bib6" ref-type="bibr">[6]</xref>
. Explanations or help were offered, when necessary.
<table-wrap id="tbl1" position="float">
<label>Table 1</label>
<caption>
<p>Questionnaire.</p>
</caption>
<alt-text id="alttext0030">Table 1</alt-text>
<graphic xlink:href="fx1a"></graphic>
<graphic xlink:href="fx1b"></graphic>
</table-wrap>
</p>
<p>All the individuals signed the term of free and informed consent, and went through the following inclusion and exclusion criteria:
<list list-type="simple">
<list-item id="o0010">
<label>a)</label>
<p>Inclusion Criteria:
<list list-type="simple">
<list-item id="u0025">
<label>-</label>
<p>Individuals of the male and female gender.</p>
</list-item>
<list-item id="u0030">
<label>-</label>
<p>Minimum age: 35 years;</p>
</list-item>
<list-item id="u0035">
<label>-</label>
<p>Smokers or nonsmokers;</p>
</list-item>
<list-item id="u0040">
<label>-</label>
<p>Who had received at least one zygomatic implant;</p>
</list-item>
<list-item id="u0045">
<label>-</label>
<p>Late loading;</p>
</list-item>
<list-item id="u0050">
<label>-</label>
<p>Immediate loading (initial insertion torque of 35 Ncm);
<xref rid="bib1" ref-type="bibr">[1]</xref>
</p>
</list-item>
<list-item id="u0055">
<label>-</label>
<p>Those who received fixed, implant supported, screw-retained dental prostheses (hybrid).</p>
</list-item>
</list>
</p>
</list-item>
<list-item id="o0015">
<label>b)</label>
<p>Exclusion Criteria:
<list list-type="simple">
<list-item id="u0060">
<label>-</label>
<p>Blind, deaf and/or dumb individuals;</p>
</list-item>
<list-item id="u0065">
<label>-</label>
<p>Those who had some type of mental deficiency;</p>
</list-item>
<list-item id="u0070">
<label>-</label>
<p>Who received implant supported overdenture prostheses;</p>
</list-item>
<list-item id="u0075">
<label>-</label>
<p>Those who failed to respond any question in the questionnaire.</p>
</list-item>
</list>
</p>
</list-item>
</list>
</p>
<p>The patients were instructed about their oral health status, especially the peri-implant tissue, and about cleaning and prevention care and techniques. We randomly removed 2 samples from Group 1 to maintain the groups paired to enable us to use tests with a correlation structure, resulting in a sample of 30 individuals, with 15 in Group 1 and 15 in Group 2. By means of clinical record charts and panoramic radiographs, the authors counted that 30 individuals selected received a total of 131 implants, of the company Conexão Sistemas de Prótese, with 64 being of the zygomatic and 67 of the conventional type. Group 1 received 40 zygomatic and 28 conventional implants; and Group 2 received 24 zygomatic and 39 conventional implants.</p>
<p>The data collected were submitted to descriptive and inferential statistical approaches. The confidence interval for the mean was calculated. The non parametric Wilcoxon test was used to compare the participants' emotional condition in the intervals of the beginning and conclusion of the treatment, irrespective of the anesthetic procedure used. The non parametric G test was applied to verify whether there was difference in the individuals' emotional condition in at the beginning of treatment, considering the type of anesthetic procedure adopted. The same test was used to compare whether there was difference in the emotional condition on conclusion of the treatment, according to the anesthetic procedure. The non parametric Mann-Whitney test was used to compare the degree of satisfaction reported by individuals whose surgeries were performed under general and local anesthesia with sedation, considering the different indicators evaluated. The Exact Fisher test was used to analyze whether there was difference with regard to the individuals' expectations about treatment when the surgical procedures were performed under general, or local anesthesia with sedation. The level of significance adopted was (P < 0,05), and the statistical calculations were performed in the BioEstat program 5.0.</p>
</sec>
<sec id="sec3">
<label>3</label>
<title>Results</title>
<p>The clinical record charts evaluated belonged to 30 individuals, with a follow-up period of 6 years, of whom 11 were men, representing 36.7% of the sample, and 19 women, totaling 63.3% of the sample. As regards age-range, the individuals were between 43 and 72 years of age, with a mean age of 56.5 and standard deviation of 6.5 years. Of the 30 individuals whose record charts were evaluated, 23 (76.7%) were nonsmokers, and 7 (23.3%), were smokers.</p>
<p>With reference to the number of zygomatic implants, four of the individuals (13.3%) had only 1. Of these four individuals, two also had 3 conventional implants, one had 5, and the other had 6 conventional implants; 22 individuals (73.3%) had 2 zygomatic implants. Among the 22, 19 also had 2 conventional implants, with the remainder (3) had 4 conventional implants. In the total of 30 individuals, 4 (13.3%) received 4 zygomatic implants, and these were not associated with conventional implants.</p>
<p>For 22 individuals (73.3%) participating in this research, the implants received immediate loading, while for 8 (26.7%), loading was not immediate. As regards the use of provisional dental prostheses, 22 individuals (73.3%) did not use any, while 8 (26.7%) made use of them. In the pre-operative condition, 22 individuals (73.3%) were complete denture wearers. The remainder; that is 8 (26.7%) were partially edentulous.</p>
<p>
<xref rid="fig1" ref-type="fig">Fig. 1</xref>
and
<xref rid="fig2" ref-type="fig">Fig. 2</xref>
demonstrate the emotional categories of individuals before and after conclusion of the treatment. In fact, the Wilcoxon test revealed that at the beginning of treatment, the emotional condition of the individuals differed from that verified after the conclusion of treatment (p < 0.0001). Therefore, irrespective of the anesthesia procedure used, before the surgical intervention, 73,3% of the individuals were characterized as anxious and nervous, emotional conditions that were not maintained after conclusion of the treatment, a time when 90% of the participants reported that they fitted into the categories of mediators or calm.
<fig id="fig1">
<label>Fig. 1</label>
<caption>
<p>Diagram of emotional category sectors into which the individuals classified themselves before the treatment began.</p>
</caption>
<alt-text id="alttext0010">Fig. 1</alt-text>
<graphic xlink:href="gr1"></graphic>
</fig>
<fig id="fig2">
<label>Fig. 2</label>
<caption>
<p>Diagram of emotional category sectors into which the individuals classified themselves after conclusion of the treatment.</p>
</caption>
<alt-text id="alttext0015">Fig. 2</alt-text>
<graphic xlink:href="gr2"></graphic>
</fig>
</p>
<p>When the reported characteristics were compared, considering the anesthetic procedure, from the results of the G test the authors observed that there were no significant differences between the patients belonging to the group submitted to general anesthesia and those submitted to local anesthesia with sedation, both in the following time intervals: (pre-operative) before the treatment began (p = 0.1871), and (post-operative) after conclusion of the treatment (p = 0.1641).
<xref rid="fig3" ref-type="fig">Fig. 3</xref>
demonstrates the number of individuals in each emotional category, according to the anesthetic procedure adopted.
<fig id="fig3">
<label>Fig. 3</label>
<caption>
<p>Column diagram of emotional categories reported by individuals, according to the type of anesthetic procedure.</p>
</caption>
<alt-text id="alttext0020">Fig. 3</alt-text>
<graphic xlink:href="gr3"></graphic>
</fig>
</p>
<p>
<xref rid="tbl2" ref-type="table">Table 2</xref>
and
<xref rid="fig4" ref-type="fig">Fig. 4</xref>
demonstrate the descriptive analysis of the indicators evaluated to compare the satisfaction of individuals rehabilitated with zygomatic implants, considering the surgical procedure performed under general anesthesia, and local anesthesia with sedation. For all aspects analyzed, the Mann-Whitney tests revealed there was no significant difference in the satisfaction of individuals submitted to general anesthesia, or local with sedation, as may be verified by the p-values shown in
<xref rid="tbl2" ref-type="table">Table 2</xref>
.
<fig id="fig4">
<label>Fig. 4</label>
<caption>
<p>Column diagram, revealing satisfaction indicators according to anesthetic procedure.</p>
</caption>
<alt-text id="alttext0025">Fig. 4</alt-text>
<graphic xlink:href="gr4"></graphic>
</fig>
<table-wrap id="tbl2" position="float">
<label>Table 2</label>
<caption>
<p>Descriptive analysis and results of the Mann-Whitney tests applied to the satisfaction indices reported by individuals submitted to general and local anesthesia association with sedation. *Level of significance of 5%.</p>
</caption>
<alt-text id="alttext0035">Table 2</alt-text>
<table frame="hsides" rules="groups">
<thead>
<tr>
<th rowspan="2">Satisfaction Indicator</th>
<th colspan="2">General Anesthesia
<hr></hr>
</th>
<th colspan="2">Local Anesthesia/Sedation
<hr></hr>
</th>
<th rowspan="2">p-Value*</th>
</tr>
<tr>
<th>Mean (sd)</th>
<th>Median</th>
<th>Mean (sd)</th>
<th>Median</th>
</tr>
</thead>
<tbody>
<tr>
<td>General satisfaction with treatment</td>
<td>9.0 (1.9)</td>
<td>10.0</td>
<td>7.4 (2.8)</td>
<td>8.5</td>
<td>0.285</td>
</tr>
<tr>
<td>Post-Operative Pain</td>
<td>7.7 (3.0)</td>
<td>8.9</td>
<td>7.8 (3.2)</td>
<td>9.5</td>
<td>0.775</td>
</tr>
<tr>
<td>Post-Operative Edema</td>
<td>7.3 (3.1)</td>
<td>9.1</td>
<td>7.8 (3.0)</td>
<td>9.4</td>
<td>0.539</td>
</tr>
<tr>
<td>Esthetics</td>
<td>9.4 (1.0)</td>
<td>10.0</td>
<td>8.3 (2.5)</td>
<td>9.5</td>
<td>0.267</td>
</tr>
<tr>
<td>Discomfort when chewing</td>
<td>9.1 (2.1)</td>
<td>10.0</td>
<td>9.4 (0.7)</td>
<td>9.9</td>
<td>0.412</td>
</tr>
<tr>
<td>Phonetics</td>
<td>8.5 (2.5)</td>
<td>9.6</td>
<td>8.0 (2.5)</td>
<td>8.9</td>
<td>0.486</td>
</tr>
<tr>
<td>Hygiene</td>
<td>7.4 (3.3)</td>
<td>9.3</td>
<td>6.8 (3.2)</td>
<td>7.0</td>
<td>0.486</td>
</tr>
<tr>
<td>Volume of denture on the palate</td>
<td>7.5 (3.7)</td>
<td>10.0</td>
<td>8.5 (2.0)</td>
<td>9.2</td>
<td>0.870</td>
</tr>
<tr>
<td>Perception with regard to site of the surgery</td>
<td>8.8 (2.7)</td>
<td>10.0</td>
<td>8.5 (3.0)</td>
<td>10.0</td>
<td>1.000</td>
</tr>
<tr>
<td>Time for insertion of the denture</td>
<td>9.1 (2.1)</td>
<td>10.0</td>
<td>8.6 (2.0)</td>
<td>10.0</td>
<td>0.461</td>
</tr>
<tr>
<td>Interest shown by school of dentistry in addressing doubts, complaints and dissatisfactions</td>
<td>8.9 (2.5)</td>
<td>10.0</td>
<td>8.3 (2.0)</td>
<td>9.0</td>
<td>0.357</td>
</tr>
<tr>
<td>Interest shown by professors and students in addressing doubts, complaints and dissatisfactions</td>
<td>8.5 (3.1)</td>
<td>10.0</td>
<td>8.7 (1.9)</td>
<td>10.0</td>
<td>0.683</td>
</tr>
</tbody>
</table>
</table-wrap>
</p>
<p>When asked whether they had different expectations as regards treatment, 21 individuals (70.0%) responded negatively, while 9 (30.0%), responded positively. The exact Fisher test revealed that there was no difference in the frequency of positive and negative responses about treatment expectations, when general and local anesthesia with sedation were compared (p = 0.5000), as shown in
<xref rid="tbl3" ref-type="table">Table 3</xref>
. The confidence interval for the mean is presented in
<xref rid="tbl4" ref-type="table">Table 4</xref>
.
<table-wrap id="tbl3" position="float">
<label>Table 3</label>
<caption>
<p>Frequency of responses as regards the different expectations of treatment, according to type of anesthetic procedure.</p>
</caption>
<alt-text id="alttext0040">Table 3</alt-text>
<table frame="hsides" rules="groups">
<thead>
<tr>
<th rowspan="2">Different expectation</th>
<th colspan="2">Anesthetic Procedure
<hr></hr>
</th>
<th rowspan="2">Total</th>
</tr>
<tr>
<th>General</th>
<th>Local with sedation</th>
</tr>
</thead>
<tbody>
<tr>
<td>No</td>
<td>11</td>
<td>10</td>
<td>21</td>
</tr>
<tr>
<td>Yes
<hr></hr>
</td>
<td>4
<hr></hr>
</td>
<td>5
<hr></hr>
</td>
<td>9
<hr></hr>
</td>
</tr>
<tr>
<td>Total</td>
<td>15</td>
<td>15</td>
<td>30</td>
</tr>
</tbody>
</table>
</table-wrap>
<table-wrap id="tbl4" position="float">
<label>Table 4</label>
<caption>
<p>Confidence interval for the mean.</p>
</caption>
<alt-text id="alttext0045">Table 4</alt-text>
<table frame="hsides" rules="groups">
<thead>
<tr>
<th rowspan="2">Type of Anesthesia</th>
<th rowspan="2">Satisfaction</th>
<th rowspan="2">Mean</th>
<th rowspan="2">Median</th>
<th rowspan="2">S</th>
<th rowspan="2">N</th>
<th colspan="2">Confidence Interval
<hr></hr>
</th>
</tr>
<tr>
<th>Lower limit</th>
<th>Upper limit</th>
</tr>
</thead>
<tbody>
<tr>
<td>General</td>
<td>Discomfort when chewing</td>
<td>9.09</td>
<td>10</td>
<td>2.12</td>
<td>15</td>
<td>7.77</td>
<td>10.42</td>
</tr>
<tr>
<td>General</td>
<td>Post-operative Pain</td>
<td>7.68</td>
<td>8.9</td>
<td>2.98</td>
<td>15</td>
<td>6.36</td>
<td>9.00</td>
</tr>
<tr>
<td>General</td>
<td>Edema</td>
<td>7.31</td>
<td>9.1</td>
<td>3.12</td>
<td>15</td>
<td>5.98</td>
<td>8.63</td>
</tr>
<tr>
<td>General</td>
<td>Esthetics</td>
<td>9.38</td>
<td>10</td>
<td>0.97</td>
<td>15</td>
<td>8.06</td>
<td>10.70</td>
</tr>
<tr>
<td>General</td>
<td>Phonetics</td>
<td>8.52</td>
<td>9.6</td>
<td>2.49</td>
<td>15</td>
<td>7.20</td>
<td>9.84</td>
</tr>
<tr>
<td>General</td>
<td>Hygiene</td>
<td>7.37</td>
<td>9.3</td>
<td>3.34</td>
<td>15</td>
<td>6.04</td>
<td>8.69</td>
</tr>
<tr>
<td>General</td>
<td>Surgical Site</td>
<td>8.84</td>
<td>10</td>
<td>2.67</td>
<td>15</td>
<td>7.52</td>
<td>10.16</td>
</tr>
<tr>
<td>General</td>
<td>Faculty Complaints</td>
<td>8.86</td>
<td>10</td>
<td>2.49</td>
<td>15</td>
<td>7.54</td>
<td>10.18</td>
</tr>
<tr>
<td>General</td>
<td>Professors' Complaints</td>
<td>8.53</td>
<td>10</td>
<td>3.14</td>
<td>15</td>
<td>7.20</td>
<td>9.85</td>
</tr>
<tr>
<td>General</td>
<td>General Satisfaction</td>
<td>8.99</td>
<td>10</td>
<td>1.86</td>
<td>15</td>
<td>7.67</td>
<td>10.32</td>
</tr>
<tr>
<td>General</td>
<td>Time</td>
<td>9.06</td>
<td>10</td>
<td>2.13</td>
<td>15</td>
<td>7.74</td>
<td>10.38</td>
</tr>
<tr>
<td>General</td>
<td>Volume</td>
<td>7.53</td>
<td>10</td>
<td>3.69</td>
<td>15</td>
<td>6.21</td>
<td>8.86</td>
</tr>
<tr>
<td>Sedation</td>
<td>Discomfort when chewing</td>
<td>9.40</td>
<td>9.9</td>
<td>0.73</td>
<td>15</td>
<td>8.08</td>
<td>10.72</td>
</tr>
<tr>
<td>Sedation</td>
<td>Post-operative Pain</td>
<td>7.79</td>
<td>9.5</td>
<td>3.22</td>
<td>15</td>
<td>6.46</td>
<td>9.11</td>
</tr>
<tr>
<td>Sedation</td>
<td>Edema</td>
<td>7.78</td>
<td>9.4</td>
<td>2.98</td>
<td>15</td>
<td>6.46</td>
<td>9.10</td>
</tr>
<tr>
<td>Sedation</td>
<td>Esthetics</td>
<td>8.25</td>
<td>9.5</td>
<td>2.51</td>
<td>15</td>
<td>6.93</td>
<td>9.58</td>
</tr>
<tr>
<td>Sedation</td>
<td>Phonetics</td>
<td>7.96</td>
<td>8.9</td>
<td>2.51</td>
<td>15</td>
<td>6.64</td>
<td>9.28</td>
</tr>
<tr>
<td>Sedation</td>
<td>Hygiene</td>
<td>6.77</td>
<td>7</td>
<td>3.22</td>
<td>15</td>
<td>5.44</td>
<td>8.09</td>
</tr>
<tr>
<td>Sedation</td>
<td>Surgical Site</td>
<td>8.54</td>
<td>10</td>
<td>3.00</td>
<td>15</td>
<td>7.22</td>
<td>9.86</td>
</tr>
<tr>
<td>Sedation</td>
<td>Faculty Complaints</td>
<td>8.32</td>
<td>9</td>
<td>1.96</td>
<td>11</td>
<td>6.77</td>
<td>9.86</td>
</tr>
<tr>
<td>Sedation</td>
<td>Professors' Complaints</td>
<td>8.70</td>
<td>10</td>
<td>1.89</td>
<td>11</td>
<td>7.15</td>
<td>10.25</td>
</tr>
<tr>
<td>Sedation</td>
<td>General Satisfaction</td>
<td>7.40</td>
<td>8.5</td>
<td>2.80</td>
<td>15</td>
<td>6.08</td>
<td>8.72</td>
</tr>
<tr>
<td>Sedation</td>
<td>Time</td>
<td>8.60</td>
<td>10</td>
<td>2.01</td>
<td>15</td>
<td>7.28</td>
<td>9.92</td>
</tr>
<tr>
<td>Sedation</td>
<td>Volume</td>
<td>8.45</td>
<td>9.2</td>
<td>1.98</td>
<td>15</td>
<td>7.13</td>
<td>9.78</td>
</tr>
</tbody>
</table>
<table-wrap-foot>
<fn id="tspara0030">
<p>S: Sample Standard Deviation.</p>
</fn>
<fn id="tspara0035">
<p>N: Sample size.</p>
</fn>
</table-wrap-foot>
</table-wrap>
</p>
</sec>
<sec id="sec4">
<label>4</label>
<title>Discussion</title>
<p>When reviewing the literature, the authors perceived that various studies related to zygomatic implants were about surgical techniques, success rates of implants and dental prostheses in the long term, in addition to problems resulting from this type of therapy
<xref rid="bib8" ref-type="bibr">[8]</xref>
,
<xref rid="bib9" ref-type="bibr">[9]</xref>
. Success was based on scientific evidence found by researchers and not from the point of view of individuals. One study evaluated the satisfaction of individuals rehabilitated with fixed dentures in the maxillary arch, with zygomatic implants versus the conventional type, and discovered that the satisfaction of individuals rehabilitated with implant supported fixed dentures in the zygomatic group was similar to that of the group that received conventional implants
<xref rid="bib5" ref-type="bibr">[5]</xref>
. By means of the OHIP-14 questionnaires and VAS, the quality of life of edentulous individuals rehabilitated with zygomatic implants was studied. Rehabilitation with implants was found to have a positive impact in the majority of the categories tested, and there was a statistically significant increase in satisfaction after the placement of implant supported dental prostheses
<xref rid="bib6" ref-type="bibr">[6]</xref>
. A research about the satisfaction of individuals who had zygomatic implants placed concluded that they were satisfied with the implants and the dental prostheses, and that that treatments with zygomatic implants was predictable and reliable
<xref rid="bib7" ref-type="bibr">[7]</xref>
. In view of the foregoing, the authors perceived that the satisfaction criteria were frequently based on the type of implant placed and dental prostheses used.</p>
<p>The few existent studies about the evaluation of satisfaction did not use comparative data such as gender; age; educational level; social profile; associated risk factors (systemic diseases, smoking, bruxism); and type of anesthesia
<xref rid="bib5" ref-type="bibr">[5]</xref>
,
<xref rid="bib7" ref-type="bibr">[7]</xref>
. In our research, we chose this latter variable for crossing and analyses of information, with a view to discovering up to what point the anesthetic procedure used could influence the satisfaction of individuals.</p>
<p>In this research we evaluated satisfaction by means of a personalized questionnaire, associated with a visual analog scale (VAS) of 10 cm. Values close to 10 meant greater satisfaction, and are used to evaluate subjective questions put to individuals. Some authors
<xref rid="bib5" ref-type="bibr">[5]</xref>
,
<xref rid="bib6" ref-type="bibr">[6]</xref>
,
<xref rid="bib10" ref-type="bibr">[10]</xref>
have also used VAS to evaluate satisfaction.</p>
<p>Zygomatic implant placement surgery may be performed in hospital, under general anesthesia
<xref rid="bib1" ref-type="bibr">[1]</xref>
,
<xref rid="bib7" ref-type="bibr">[7]</xref>
,
<xref rid="bib10" ref-type="bibr">[10]</xref>
,
<xref rid="bib11" ref-type="bibr">[11]</xref>
,
<xref rid="bib12" ref-type="bibr">[12]</xref>
,
<xref rid="bib13" ref-type="bibr">[13]</xref>
or in the outpatient clinic, with local anesthesia and with either intravenous
<xref rid="bib3" ref-type="bibr">[3]</xref>
,
<xref rid="bib14" ref-type="bibr">[14]</xref>
,
<xref rid="bib15" ref-type="bibr">[15]</xref>
,
<xref rid="bib16" ref-type="bibr">[16]</xref>
or oral
<xref rid="bib16" ref-type="bibr">[16]</xref>
sedation. In one study
<xref rid="bib17" ref-type="bibr">[17]</xref>
the authors reviewed the literature of the last six years and reported that general anesthesia was used in the majority of the studies. Recently, the anesthetic protocol was simplified with the use of local anesthesia and oral or intravenous sedation. This procedure is recommended for experienced surgeons, and a surgical time programmed to last less than 1.5 h is well tolerated by the individual. The surgery is facilitated because it works with a conscious individual
<xref rid="bib16" ref-type="bibr">[16]</xref>
. In this research, 3 individuals of Group 2 had the surgeries performed with local anesthesia and oral sedation, since they were performed by an experienced professional in a reduced surgical time.</p>
<p>The results of this research revealed there was no significant difference in the satisfaction of individuals submitted to general anesthesia, or local with sedation, from all the aspects analyzed. These data allowed the authors to affirm that for the two groups of individuals studied, the anesthetic protocols did not have an influence on satisfaction, showing that it was possible to perform the surgical procedure in hospital under general anesthesia, or in the outpatient clinic with local anesthesia and sedation
<xref rid="bib16" ref-type="bibr">[16]</xref>
. This is an important datum for surgeries, considering that with the appearance of new zygomatic implant placement techniques - the exteriorized and extramaxillary types
<xref rid="bib16" ref-type="bibr">[16]</xref>
,
<xref rid="bib18" ref-type="bibr">[18]</xref>
,
<xref rid="bib19" ref-type="bibr">[19]</xref>
, in which the zygomatic implants pass outside the maxillary sinus, the surgical time is reduced, allowing the surgical procedure to be performed in an outpatient clinic with local anesthesia and sedation, for both immediate and late loading
<xref rid="bib20" ref-type="bibr">[20]</xref>
,
<xref rid="bib21" ref-type="bibr">[21]</xref>
. For the individuals, having the procedure performed in an outpatient clinic reduces financial expenditure on hospital intervention, in addition to being able to go home soon after surgery is concluded, provided they are operated on by experienced professionals
<xref rid="bib16" ref-type="bibr">[16]</xref>
.</p>
<p>Irrespective of the anesthetic protocol used, the emotional state of individuals at the beginning of treatment differed from that on conclusion of treatment, as a significant result was obtained. In truth, 22 individuals were completely edentulous (complete denture wearers) and 8 were partially edentulous. Only those who make use of removable partial dentures are able to explain what it is like to use them, thereby changing their emotional status, particularly in the work studied, in which the superior maxillae were atrophied, with little retention for complete and/or partial dental prostheses, with this situation being an indication for the placement of zygomatic implants. The fact of being rehabilitated with fixed zygomatic implant supported (hybrid) dental prostheses improved the emotional status of the individuals. This fact was perceived during the evaluation and measured by means of the high value placed on the requisite of general satisfaction with the treatment, promoting an improvement in the quality of life
<xref rid="bib6" ref-type="bibr">[6]</xref>
,
<xref rid="bib7" ref-type="bibr">[7]</xref>
. A limitation of this study was the low number of individuals that participated in this research, and the few scientific articles about satisfaction published up to now to enable data crossing
<xref rid="bib5" ref-type="bibr">[5]</xref>
,
<xref rid="bib6" ref-type="bibr">[6]</xref>
,
<xref rid="bib7" ref-type="bibr">[7]</xref>
. Further multi centric researches are necessary with a view to increasing the number of individuals studied, with more studies evaluating satisfaction related to anesthetic protocols and other variables to enable the crossing of data and analyses of new items of information.</p>
</sec>
<sec id="sec5">
<label>5</label>
<title>Conclusion</title>
<p>For the sample studied, there was no significant difference in any of the requisites evaluated with regard to the satisfaction of individuals rehabilitated with zygomatic implants, under general anesthesia, or local with intravenous or oral sedation. General satisfaction with treatment was high. From the emotional point of view of the individuals, irrespective of the anesthetic procedure used, there was emotional improvement after the conclusion of treatment (p < 0.0001), thus improving the quality of life. The authors suggest repetition of this study with a larger number of individuals, in addition to evaluating satisfaction based on other variables.</p>
</sec>
<sec id="sec6">
<title>Ethical approval</title>
<p>Research Ethics Committee (REC) of the São Leopoldo Mandic Dental School, protocol number 2011/0431.</p>
</sec>
<sec id="sec7">
<title>Sources of funding</title>
<p>None.</p>
</sec>
<sec id="sec8">
<title>Author contribution</title>
<p>Study design: Paulo H. T. Almeida, Alexander D'Alvia Salvoni.</p>
<p>Data collection: Paulo H. T. Almeida, Alexander D'Alvia Salvoni.</p>
<p>Data analysis: Paulo H. T. Almeida.</p>
<p>Manuscript preparation: Paulo H. T. Almeida.</p>
<p>Critical revision: Paulo H. T. Almeida, Alexander D'Alvia Salvoni, Fabiana M. G. França.</p>
</sec>
<sec id="sec9">
<title>Conflicts of interest</title>
<p>None declared.</p>
</sec>
<sec id="sec10">
<title>Research registration unique identifying number (UIN)</title>
<p>Research registry 2395.</p>
</sec>
<sec id="sec11">
<title>Trial registry number – ISRCTN</title>
<p>None declared.</p>
</sec>
<sec id="sec12">
<title>Guarantor</title>
<p>Paulo Henrique Teles de Almeida.</p>
</sec>
</body>
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