Cost-effectiveness analysis of the single-implant mandibular overdenture versus conventional complete denture: study protocol for a randomized controlled trial
Identifieur interne : 000D91 ( Pmc/Curation ); précédent : 000D90; suivant : 000D92Cost-effectiveness analysis of the single-implant mandibular overdenture versus conventional complete denture: study protocol for a randomized controlled trial
Auteurs : Túlio Eduardo Nogueira ; Shahrokh Esfandiari [Canada] ; Cláudio Rodrigues LelesSource :
- Trials [ 1745-6215 ] ; 2016.
Abstract
Preliminary clinical studies on the single-implant mandibular overdenture (SIMO) have reported favorable results as an alternative to the conventional complete dentures for rehabilitation of the edentulous mandible. Clinical and patient-reported outcomes were assessed but no evidence is available with respect to the cost-effectiveness of this treatment, which is particularly important to test whether the incremental cost associated with the implant treatment is justified facing the benefits from the intervention. Thus, the aim of this study is to assess the cost-effectiveness of single-implant mandibular overdentures.
This randomized clinical trial will include edentulous individuals who meet eligibility criteria. Participants will be randomized into one of the treatment groups: a conventional complete denture group or a single-implant mandibular overdenture group. Direct costs related to therapies in both groups will be identified, measured and valuated for 1 year after treatment. Oral health-related quality of life and satisfaction with the dentures will be the primary outcome variables. Incremental cost-effectiveness ratios will be estimated and graphically presented on cost-effectiveness planes. A Markov decision tree will be constructed to set out the consequences of the competing alternatives. Sensitivity analysis on the most important assumptions will be performed in order to assess the robustness of the model.
This is the first trial-based cost-effectiveness study on single-implant mandibular overdentures. Specific challenges in designing the protocol are considered. The expected results are of high clinical relevance and may contribute to the decision-making process when choosing between different alternatives for the rehabilitation of the edentulous mandible.
ClinicalTrials.gov Identifier:
The online version of this article (doi:10.1186/s13063-016-1646-0) contains supplementary material, which is available to authorized users.
Url:
DOI: 10.1186/s13063-016-1646-0
PubMed: 27814749
PubMed Central: 5097429
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Túlio Eduardo Nogueira<affiliation><nlm:aff id="Aff1">School of Dentistry, Federal University of Goiás, Avenida Universitária Esquina com 1ª Avenida, s/n. Setor Universitário, Goiânia, Goiás CEP 74605-220 Brazil</nlm:aff>
<wicri:noCountry code="subfield">Goiás CEP 74605-220 Brazil</wicri:noCountry>
</affiliation>
<affiliation><nlm:aff id="Aff1">School of Dentistry, Federal University of Goiás, Avenida Universitária Esquina com 1ª Avenida, s/n. Setor Universitário, Goiânia, Goiás CEP 74605-220 Brazil</nlm:aff>
<wicri:noCountry code="subfield">Goiás CEP 74605-220 Brazil</wicri:noCountry>
</affiliation>
Le document en format XML
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<author><name sortKey="Nogueira, Tulio Eduardo" sort="Nogueira, Tulio Eduardo" uniqKey="Nogueira T" first="Túlio Eduardo" last="Nogueira">Túlio Eduardo Nogueira</name>
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<author><name sortKey="Esfandiari, Shahrokh" sort="Esfandiari, Shahrokh" uniqKey="Esfandiari S" first="Shahrokh" last="Esfandiari">Shahrokh Esfandiari</name>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Cost-effectiveness analysis of the single-implant mandibular overdenture versus conventional complete denture: study protocol for a randomized controlled trial</title>
<author><name sortKey="Nogueira, Tulio Eduardo" sort="Nogueira, Tulio Eduardo" uniqKey="Nogueira T" first="Túlio Eduardo" last="Nogueira">Túlio Eduardo Nogueira</name>
<affiliation><nlm:aff id="Aff1">School of Dentistry, Federal University of Goiás, Avenida Universitária Esquina com 1ª Avenida, s/n. Setor Universitário, Goiânia, Goiás CEP 74605-220 Brazil</nlm:aff>
<wicri:noCountry code="subfield">Goiás CEP 74605-220 Brazil</wicri:noCountry>
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<author><name sortKey="Esfandiari, Shahrokh" sort="Esfandiari, Shahrokh" uniqKey="Esfandiari S" first="Shahrokh" last="Esfandiari">Shahrokh Esfandiari</name>
<affiliation wicri:level="4"><nlm:aff id="Aff2">Faculty of Dentistry, McGill University, 2001 McGill College Avenue, suite 500, Montreal, QC H3A 1G1 Canada</nlm:aff>
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<placeName><settlement type="city">Montréal</settlement>
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<author><name sortKey="Leles, Claudio Rodrigues" sort="Leles, Claudio Rodrigues" uniqKey="Leles C" first="Cláudio Rodrigues" last="Leles">Cláudio Rodrigues Leles</name>
<affiliation><nlm:aff id="Aff1">School of Dentistry, Federal University of Goiás, Avenida Universitária Esquina com 1ª Avenida, s/n. Setor Universitário, Goiânia, Goiás CEP 74605-220 Brazil</nlm:aff>
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<series><title level="j">Trials</title>
<idno type="eISSN">1745-6215</idno>
<imprint><date when="2016">2016</date>
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<front><div type="abstract" xml:lang="en"><sec><title>Background</title>
<p>Preliminary clinical studies on the single-implant mandibular overdenture (SIMO) have reported favorable results as an alternative to the conventional complete dentures for rehabilitation of the edentulous mandible. Clinical and patient-reported outcomes were assessed but no evidence is available with respect to the cost-effectiveness of this treatment, which is particularly important to test whether the incremental cost associated with the implant treatment is justified facing the benefits from the intervention. Thus, the aim of this study is to assess the cost-effectiveness of single-implant mandibular overdentures.</p>
</sec>
<sec><title>Methods/design</title>
<p>This randomized clinical trial will include edentulous individuals who meet eligibility criteria. Participants will be randomized into one of the treatment groups: a conventional complete denture group or a single-implant mandibular overdenture group. Direct costs related to therapies in both groups will be identified, measured and valuated for 1 year after treatment. Oral health-related quality of life and satisfaction with the dentures will be the primary outcome variables. Incremental cost-effectiveness ratios will be estimated and graphically presented on cost-effectiveness planes. A Markov decision tree will be constructed to set out the consequences of the competing alternatives. Sensitivity analysis on the most important assumptions will be performed in order to assess the robustness of the model.</p>
</sec>
<sec><title>Discussion</title>
<p>This is the first trial-based cost-effectiveness study on single-implant mandibular overdentures. Specific challenges in designing the protocol are considered. The expected results are of high clinical relevance and may contribute to the decision-making process when choosing between different alternatives for the rehabilitation of the edentulous mandible.</p>
</sec>
<sec><title>Trial registration</title>
<p>ClinicalTrials.gov Identifier: <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT02710357">NCT02710357</ext-link>
, registered on 11 March 2016.</p>
</sec>
<sec><title>Electronic supplementary material</title>
<p>The online version of this article (doi:10.1186/s13063-016-1646-0) contains supplementary material, which is available to authorized users.</p>
</sec>
</div>
</front>
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</TEI>
<pmc article-type="research-article"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Trials</journal-id>
<journal-id journal-id-type="iso-abbrev">Trials</journal-id>
<journal-title-group><journal-title>Trials</journal-title>
</journal-title-group>
<issn pub-type="epub">1745-6215</issn>
<publisher><publisher-name>BioMed Central</publisher-name>
<publisher-loc>London</publisher-loc>
</publisher>
</journal-meta>
<article-meta><article-id pub-id-type="pmid">27814749</article-id>
<article-id pub-id-type="pmc">5097429</article-id>
<article-id pub-id-type="publisher-id">1646</article-id>
<article-id pub-id-type="doi">10.1186/s13063-016-1646-0</article-id>
<article-categories><subj-group subj-group-type="heading"><subject>Study Protocol</subject>
</subj-group>
</article-categories>
<title-group><article-title>Cost-effectiveness analysis of the single-implant mandibular overdenture versus conventional complete denture: study protocol for a randomized controlled trial</article-title>
</title-group>
<contrib-group><contrib contrib-type="author"><name><surname>Nogueira</surname>
<given-names>Túlio Eduardo</given-names>
</name>
<address><phone>+55 62 8170-1436</phone>
<email>tulioen@uol.com.br</email>
</address>
<xref ref-type="aff" rid="Aff1">1</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Esfandiari</surname>
<given-names>Shahrokh</given-names>
</name>
<address><phone>(514) 398-6244</phone>
<email>shahrokh.esfandiari@mcgill.ca</email>
</address>
<xref ref-type="aff" rid="Aff2">2</xref>
</contrib>
<contrib contrib-type="author" corresp="yes"><name><surname>Leles</surname>
<given-names>Cláudio Rodrigues</given-names>
</name>
<address><phone>+55 62 8170-1436</phone>
<phone>+55 62 8111 3302</phone>
<email>claudio_leles@ufg.br</email>
</address>
<xref ref-type="aff" rid="Aff1">1</xref>
</contrib>
<aff id="Aff1"><label>1</label>
School of Dentistry, Federal University of Goiás, Avenida Universitária Esquina com 1ª Avenida, s/n. Setor Universitário, Goiânia, Goiás CEP 74605-220 Brazil</aff>
<aff id="Aff2"><label>2</label>
Faculty of Dentistry, McGill University, 2001 McGill College Avenue, suite 500, Montreal, QC H3A 1G1 Canada</aff>
</contrib-group>
<pub-date pub-type="epub"><day>4</day>
<month>11</month>
<year>2016</year>
</pub-date>
<pub-date pub-type="pmc-release"><day>4</day>
<month>11</month>
<year>2016</year>
</pub-date>
<pub-date pub-type="collection"><year>2016</year>
</pub-date>
<volume>17</volume>
<elocation-id>533</elocation-id>
<history><date date-type="received"><day>20</day>
<month>4</month>
<year>2016</year>
</date>
<date date-type="accepted"><day>5</day>
<month>10</month>
<year>2016</year>
</date>
</history>
<permissions><copyright-statement>© The Author(s). 2016</copyright-statement>
<license license-type="OpenAccess"><license-p><bold>Open Access</bold>
This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by/4.0/">http://creativecommons.org/licenses/by/4.0/</ext-link>
), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/publicdomain/zero/1.0/">http://creativecommons.org/publicdomain/zero/1.0/</ext-link>
) applies to the data made available in this article, unless otherwise stated.</license-p>
</license>
</permissions>
<abstract id="Abs1"><sec><title>Background</title>
<p>Preliminary clinical studies on the single-implant mandibular overdenture (SIMO) have reported favorable results as an alternative to the conventional complete dentures for rehabilitation of the edentulous mandible. Clinical and patient-reported outcomes were assessed but no evidence is available with respect to the cost-effectiveness of this treatment, which is particularly important to test whether the incremental cost associated with the implant treatment is justified facing the benefits from the intervention. Thus, the aim of this study is to assess the cost-effectiveness of single-implant mandibular overdentures.</p>
</sec>
<sec><title>Methods/design</title>
<p>This randomized clinical trial will include edentulous individuals who meet eligibility criteria. Participants will be randomized into one of the treatment groups: a conventional complete denture group or a single-implant mandibular overdenture group. Direct costs related to therapies in both groups will be identified, measured and valuated for 1 year after treatment. Oral health-related quality of life and satisfaction with the dentures will be the primary outcome variables. Incremental cost-effectiveness ratios will be estimated and graphically presented on cost-effectiveness planes. A Markov decision tree will be constructed to set out the consequences of the competing alternatives. Sensitivity analysis on the most important assumptions will be performed in order to assess the robustness of the model.</p>
</sec>
<sec><title>Discussion</title>
<p>This is the first trial-based cost-effectiveness study on single-implant mandibular overdentures. Specific challenges in designing the protocol are considered. The expected results are of high clinical relevance and may contribute to the decision-making process when choosing between different alternatives for the rehabilitation of the edentulous mandible.</p>
</sec>
<sec><title>Trial registration</title>
<p>ClinicalTrials.gov Identifier: <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT02710357">NCT02710357</ext-link>
, registered on 11 March 2016.</p>
</sec>
<sec><title>Electronic supplementary material</title>
<p>The online version of this article (doi:10.1186/s13063-016-1646-0) contains supplementary material, which is available to authorized users.</p>
</sec>
</abstract>
<kwd-group xml:lang="en"><title>Keywords</title>
<kwd>Cost-effectiveness</kwd>
<kwd>Economic evaluation</kwd>
<kwd>Dental economics</kwd>
<kwd>Overdentures</kwd>
<kwd>Complete dentures</kwd>
<kwd>Patient satisfaction</kwd>
</kwd-group>
<funding-group><award-group><funding-source><institution-wrap><institution-id institution-id-type="FundRef">1552</institution-id>
<institution>International Team for Implantology (ITI)</institution>
</institution-wrap>
</funding-source>
<award-id>ITI Grant number 966_2014</award-id>
<principal-award-recipient><name><surname>Leles</surname>
<given-names>Cláudio Rodrigues</given-names>
</name>
</principal-award-recipient>
</award-group>
</funding-group>
<custom-meta-group><custom-meta><meta-name>issue-copyright-statement</meta-name>
<meta-value>© The Author(s) 2016</meta-value>
</custom-meta>
</custom-meta-group>
</article-meta>
</front>
</pmc>
</record>
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