A pilot randomised controlled trial evaluating mini and conventional implant retained dentures on the function and quality of life of patients with an edentulous mandible
Identifieur interne : 000370 ( Main/Exploration ); précédent : 000369; suivant : 000371A pilot randomised controlled trial evaluating mini and conventional implant retained dentures on the function and quality of life of patients with an edentulous mandible
Auteurs : Sarra Jawad ; Craig Barclay ; William Whittaker [Royaume-Uni] ; Martin Tickle [Royaume-Uni] ; Tanya Walsh [Royaume-Uni]Source :
- BMC Oral Health [ 1472-6831 ] ; 2017.
Abstract
Total tooth loss (edentulism) can be a debilitating condition, impacting on ability to chew, speak and interact with others. The most common treatment is with complete removable dentures, which may be successful, but in the lower jaw, bone resorption that worsens over time makes denture-wearing difficult. Two dental implants in the mandible to retain the lower denture has been advocated as the gold standard of treatment, but has not been universally provided due largely to financial constraints and also patient fear. Mini implants (MI) are cheaper and less invasive than conventional implants (CI), but may not have equivalent longevity. Therefore, it is unknown whether they represent a cost-effective treatment modality over time. The aim of this pilot randomised controlled trial was to assess the feasibility of carrying out a trial on this cohort of patients, and to inform the study design of a large multicentre trial.
Forty-six patients were randomly allocated to receive either two mini implants or two conventional implants in the mandible to retain their lower dentures. Quality of life (QoL) questionnaires, pain and anxiety scores, and an objective “gummy jelly” chewing test were carried out at multiple timepoints, along with detailed health economics information. Implants were placed one-stage, and an early loading protocol was utilised. Patients were reviewed 8 weeks post-placement, and finally at 6 months. Implant failure, recruitment and retention rates were recorded and analysed.
The pilot study demonstrated that it is possible to recruit, randomise and retain edentulous (mainly elderly) patients for an implant trial. We recruited to target and retention rates were acceptable. The large number of questionnaires was onerous for participants to complete, but the distribution of scores and feedback from participants helped inform the choice of primary and secondary outcomes in a full trial. The chewing test was time-consuming and inconsistent. Implant failure rate was low (1/46). The data on indirect costs gathered at every visit was viewed as repetitive and unnecessary, as there was little or no change between visits.
The pilot study has shown that acceptable recruitment and retention rates are achievable in this population of patients for this intervention. The results provide valuable information for selection of outcome variables and sample size calculations for future trials.
(ISRCTN):
The online version of this article (doi:10.1186/s12903-017-0333-1) contains supplementary material, which is available to authorized users.
Url:
DOI: 10.1186/s12903-017-0333-1
PubMed: 28202072
PubMed Central: 5310054
Affiliations:
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id="Aff1"><institution-wrap><institution-id institution-id-type="ISNI">0000 0000 9422 0792</institution-id><institution-id institution-id-type="GRID">grid.412454.2</institution-id><institution>Department of Restorative Dentistry,</institution><institution>University Dental Hospital of Manchester,</institution></institution-wrap>Higher Cambridge Street, Manchester, M15 6FH UK</nlm:aff><wicri:noCountry code="subfield">M15 6FH UK</wicri:noCountry></affiliation></author><author><name sortKey="Barclay, Craig" sort="Barclay, Craig" uniqKey="Barclay C" first="Craig" last="Barclay">Craig Barclay</name><affiliation><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="ISNI">0000 0000 9422 0792</institution-id><institution-id institution-id-type="GRID">grid.412454.2</institution-id><institution>Department of Restorative Dentistry,</institution><institution>University Dental Hospital of Manchester,</institution></institution-wrap>Higher Cambridge Street, Manchester, M15 6FH UK</nlm:aff><wicri:noCountry code="subfield">M15 6FH UK</wicri:noCountry></affiliation></author><author><name sortKey="Whittaker, William" sort="Whittaker, William" uniqKey="Whittaker W" first="William" last="Whittaker">William Whittaker</name><affiliation wicri:level="1"><nlm:aff id="Aff2"><institution-wrap><institution-id institution-id-type="ISNI">0000000121662407</institution-id><institution-id institution-id-type="GRID">grid.5379.8</institution-id><institution>Division of Population Health, Health Services Research and Primary Care, School of Health Sciences,</institution><institution>University of Manchester,</institution></institution-wrap>Manchester, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Manchester</wicri:regionArea></affiliation></author><author><name sortKey="Tickle, Martin" sort="Tickle, Martin" uniqKey="Tickle M" first="Martin" last="Tickle">Martin Tickle</name><affiliation wicri:level="1"><nlm:aff id="Aff3"><institution-wrap><institution-id institution-id-type="ISNI">0000000121662407</institution-id><institution-id institution-id-type="GRID">grid.5379.8</institution-id><institution>Division of Dentistry, Faculty of Biology, Medicine and Health,</institution><institution>University of Manchester,</institution></institution-wrap>Manchester, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Manchester</wicri:regionArea></affiliation></author><author><name sortKey="Walsh, Tanya" sort="Walsh, Tanya" uniqKey="Walsh T" first="Tanya" last="Walsh">Tanya Walsh</name><affiliation wicri:level="1"><nlm:aff id="Aff3"><institution-wrap><institution-id institution-id-type="ISNI">0000000121662407</institution-id><institution-id institution-id-type="GRID">grid.5379.8</institution-id><institution>Division of Dentistry, Faculty of Biology, Medicine and Health,</institution><institution>University of Manchester,</institution></institution-wrap>Manchester, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Manchester</wicri:regionArea></affiliation></author></analytic><series><title level="j">BMC Oral Health</title><idno type="eISSN">1472-6831</idno><imprint><date when="2017">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>Total tooth loss (edentulism) can be a debilitating condition, impacting on ability to chew, speak and interact with others. The most common treatment is with complete removable dentures, which may be successful, but in the lower jaw, bone resorption that worsens over time makes denture-wearing difficult. Two dental implants in the mandible to retain the lower denture has been advocated as the gold standard of treatment, but has not been universally provided due largely to financial constraints and also patient fear. Mini implants (MI) are cheaper and less invasive than conventional implants (CI), but may not have equivalent longevity. Therefore, it is unknown whether they represent a cost-effective treatment modality over time. The aim of this pilot randomised controlled trial was to assess the feasibility of carrying out a trial on this cohort of patients, and to inform the study design of a large multicentre trial.</p></sec><sec><title>Methods</title><p>Forty-six patients were randomly allocated to receive either two mini implants or two conventional implants in the mandible to retain their lower dentures. Quality of life (QoL) questionnaires, pain and anxiety scores, and an objective “gummy jelly” chewing test were carried out at multiple timepoints, along with detailed health economics information. Implants were placed one-stage, and an early loading protocol was utilised. Patients were reviewed 8 weeks post-placement, and finally at 6 months. Implant failure, recruitment and retention rates were recorded and analysed.</p></sec><sec><title>Results</title><p>The pilot study demonstrated that it is possible to recruit, randomise and retain edentulous (mainly elderly) patients for an implant trial. We recruited to target and retention rates were acceptable. The large number of questionnaires was onerous for participants to complete, but the distribution of scores and feedback from participants helped inform the choice of primary and secondary outcomes in a full trial. The chewing test was time-consuming and inconsistent. Implant failure rate was low (1/46). The data on indirect costs gathered at every visit was viewed as repetitive and unnecessary, as there was little or no change between visits.</p></sec><sec><title>Conclusions</title><p>The pilot study has shown that acceptable recruitment and retention rates are achievable in this population of patients for this intervention. The results provide valuable information for selection of outcome variables and sample size calculations for future trials.</p></sec><sec><title>Trial registration</title><p>(ISRCTN): <ext-link ext-link-type="uri" xlink:href="http://www.isrctn.com/ISRCTN87342238">87342238</ext-link> Trial registration date: 05/07/2013.</p></sec><sec><title>Electronic supplementary material</title><p>The online version of this article (doi:10.1186/s12903-017-0333-1) contains supplementary material, which is available to authorized users.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Organization, Wh" uniqKey="Organization W">WH Organization</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Petersen, Pe" uniqKey="Petersen P">PE Petersen</name></author><author><name sortKey="Bourgeois, D" uniqKey="Bourgeois D">D Bourgeois</name></author><author><name sortKey="Ogawa, H" uniqKey="Ogawa H">H 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sortKey="Morrison, T" uniqKey="Morrison T">T Morrison</name></author><author><name sortKey="Lindsay, S" uniqKey="Lindsay S">S Lindsay</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Allen, F" uniqKey="Allen F">F Allen</name></author><author><name sortKey="Locker, D" uniqKey="Locker D">D Locker</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Group, Te" uniqKey="Group T">TE Group</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Ware, J" uniqKey="Ware J">J Ware</name></author><author><name sortKey="Kosinski, M" uniqKey="Kosinski M">M Kosinski</name></author><author><name sortKey="Turner Bowker, D" uniqKey="Turner Bowker D">D Turner-Bowker</name></author><author><name sortKey="Gandek, B" uniqKey="Gandek B">B Gandek</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Royaume-Uni</li></country></list><tree><noCountry><name sortKey="Barclay, Craig" sort="Barclay, Craig" uniqKey="Barclay C" first="Craig" last="Barclay">Craig Barclay</name><name sortKey="Jawad, Sarra" sort="Jawad, Sarra" uniqKey="Jawad S" first="Sarra" last="Jawad">Sarra Jawad</name></noCountry><country name="Royaume-Uni"><noRegion><name sortKey="Whittaker, William" sort="Whittaker, William" uniqKey="Whittaker W" first="William" last="Whittaker">William Whittaker</name></noRegion><name sortKey="Tickle, Martin" sort="Tickle, Martin" uniqKey="Tickle M" first="Martin" last="Tickle">Martin Tickle</name><name sortKey="Walsh, Tanya" sort="Walsh, Tanya" uniqKey="Walsh T" first="Tanya" last="Walsh">Tanya Walsh</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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