Improvdent: Improving dentures for patient benefit. A crossover randomised clinical trial comparing impression materials for complete dentures
Identifieur interne : 004086 ( Ncbi/Merge ); précédent : 004085; suivant : 004087Improvdent: Improving dentures for patient benefit. A crossover randomised clinical trial comparing impression materials for complete dentures
Auteurs : Janine C. Gray [Royaume-Uni] ; Nuria Navarro-Coy [Royaume-Uni] ; Sue H. Pavitt [Royaume-Uni] ; Claire Hulme [Royaume-Uni] ; Mary Godfrey [Royaume-Uni] ; Helen L. Craddock [Royaume-Uni] ; Paul A. Brunton [Royaume-Uni] ; Sarah Brown [Royaume-Uni] ; Sean Dillon [Royaume-Uni] ; Gillian Dukanovic [Royaume-Uni] ; Catherine Fernandez [Royaume-Uni] ; Jonathan Wright [Royaume-Uni] ; Howard Collier [Royaume-Uni] ; Shirley Swithenbank [Royaume-Uni] ; Carol Lee [Royaume-Uni] ; T Paul Hyde [Royaume-Uni]Source :
- BMC Oral Health [ 1472-6831 ] ; 2012.
Abstract
According to the UK Adult Dental Health Survey (2009) 15% of adults aged 65–74, 30% aged 75–84 and 47% aged >85 years are edentulous and require complete dentures. Patients’ quality of life and nutrition status are affected by poor dentures. The quality of the dental impression is the most important issue for improving the fit and comfort of new dentures. There is paucity of RCT evidence for which impression material is best for complete dentures construction. This study aims to compare two impression materials for effectiveness and cost effectiveness.
IMPROVDENT is a double-blind crossover trial comparing the use of alginate and silicone, two commonly used denture impression materials, in terms of patient preference and cost-effectiveness. Eighty five edentulous patients will be recruited and provided with two sets of dentures, similar in all aspects except for the impression material used (alginate or silicone). Patients will try both sets of dentures for a two-week period, unadjusted, to become accustomed to the feel of the new dentures (habituation period). Patients will then wear each set of dentures for a period of 8 weeks (in random order) during which time the dentures will be adjusted for optimum comfort. Finally, patients will be given both sets of dentures for a further two weeks to wear whichever denture they prefer (confirmation period).
Patients will be asked about quality of life and to rate dentures on function and comfort at the end of each trial period and asked which set they prefer at the end of the habituation period (unadjusted denture preference) and confirmation period (adjusted denture preference). A health economic evaluation will estimate incremental cost-effectiveness ratios of producing dentures from the two materials. A qualitative study will investigate the impact of dentures on behaviour and quality of life.
Funding: IMPROVDENT is funded by NIHR RfPB (PB-PG-0408-16300).
This trial aims to provide evidence on the costs and quality of dentures cast from two different commonly used impression materials; the intention is to significantly impact on the quality of denture production within NHS dentistry.
ISRCTN Register: ISRCTN01528038
UKCRN Portfolio ID: 8305
Url:
DOI: 10.1186/1472-6831-12-37
PubMed: 22937901
PubMed Central: 3532377
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Gray</name><affiliation wicri:level="4"><nlm:aff id="I1">Clinical Trials Research Unit, University of Leeds, Leeds, LS2 9JT, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Clinical Trials Research Unit, University of Leeds, Leeds, LS2 9JT</wicri:regionArea><orgName type="university">Université de Leeds</orgName><placeName><settlement type="city">Leeds</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Yorkshire-et-Humber</region></placeName></affiliation></author><author><name sortKey="Navarro Coy, Nuria" sort="Navarro Coy, Nuria" uniqKey="Navarro Coy N" first="Nuria" last="Navarro-Coy">Nuria Navarro-Coy</name><affiliation wicri:level="4"><nlm:aff id="I1">Clinical Trials Research Unit, University of Leeds, Leeds, LS2 9JT, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Clinical Trials Research Unit, University of Leeds, Leeds, LS2 9JT</wicri:regionArea><orgName type="university">Université de Leeds</orgName><placeName><settlement type="city">Leeds</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Yorkshire-et-Humber</region></placeName></affiliation></author><author><name sortKey="Pavitt, Sue H" sort="Pavitt, Sue H" uniqKey="Pavitt S" first="Sue H" last="Pavitt">Sue H. 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de Leeds</orgName><placeName><settlement type="city">Leeds</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Yorkshire-et-Humber</region></placeName></affiliation></author><author><name sortKey="Swithenbank, Shirley" sort="Swithenbank, Shirley" uniqKey="Swithenbank S" first="Shirley" last="Swithenbank">Shirley Swithenbank</name><affiliation wicri:level="4"><nlm:aff id="I6">IMPROVDENT PPI representatives, c/o Leeds Dental Institute, Clarendon Road, University of Leeds, Leeds, LS2 9LU, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>IMPROVDENT PPI representatives, c/o Leeds Dental Institute, Clarendon Road, University of Leeds, Leeds, LS2 9LU</wicri:regionArea><orgName type="university">Université de Leeds</orgName><placeName><settlement type="city">Leeds</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Yorkshire-et-Humber</region></placeName></affiliation></author><author><name sortKey="Lee, Carol" sort="Lee, Carol" uniqKey="Lee C" first="Carol" last="Lee">Carol Lee</name><affiliation wicri:level="4"><nlm:aff id="I6">IMPROVDENT PPI representatives, c/o Leeds Dental Institute, Clarendon Road, University of Leeds, Leeds, LS2 9LU, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>IMPROVDENT PPI representatives, c/o Leeds Dental Institute, Clarendon Road, University of Leeds, Leeds, LS2 9LU</wicri:regionArea><orgName type="university">Université de Leeds</orgName><placeName><settlement type="city">Leeds</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Yorkshire-et-Humber</region></placeName></affiliation></author><author><name sortKey="Hyde, T Paul" sort="Hyde, T Paul" uniqKey="Hyde T" first="T Paul" last="Hyde">T Paul Hyde</name><affiliation wicri:level="4"><nlm:aff id="I5">Leeds Dental Institute, Clarendon Road, University of Leeds, Leeds, LS2 9LU, UK</nlm:aff><country 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A crossover randomised clinical trial comparing impression materials for complete dentures</title><author><name sortKey="Gray, Janine C" sort="Gray, Janine C" uniqKey="Gray J" first="Janine C" last="Gray">Janine C. Gray</name><affiliation wicri:level="4"><nlm:aff id="I1">Clinical Trials Research Unit, University of Leeds, Leeds, LS2 9JT, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Clinical Trials Research Unit, University of Leeds, Leeds, LS2 9JT</wicri:regionArea><orgName type="university">Université de Leeds</orgName><placeName><settlement type="city">Leeds</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Yorkshire-et-Humber</region></placeName></affiliation></author><author><name sortKey="Navarro Coy, Nuria" sort="Navarro Coy, Nuria" uniqKey="Navarro Coy N" first="Nuria" last="Navarro-Coy">Nuria Navarro-Coy</name><affiliation wicri:level="4"><nlm:aff id="I1">Clinical Trials Research Unit, University of Leeds, Leeds, LS2 9JT, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Clinical Trials Research Unit, University of Leeds, Leeds, LS2 9JT</wicri:regionArea><orgName type="university">Université de Leeds</orgName><placeName><settlement type="city">Leeds</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Yorkshire-et-Humber</region></placeName></affiliation></author><author><name sortKey="Pavitt, Sue H" sort="Pavitt, Sue H" uniqKey="Pavitt S" first="Sue H" last="Pavitt">Sue H. Pavitt</name><affiliation wicri:level="4"><nlm:aff id="I2">Centre for Health Sciences Research, Leeds Institute of Health Sciences, University of Leeds, Charles Thackrah, 101 Clarendon Road, Leeds, LS2 9LJ, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Centre for Health Sciences Research, Leeds Institute of Health Sciences, University of Leeds, Charles Thackrah, 101 Clarendon Road, Leeds, LS2 9LJ</wicri:regionArea><orgName type="university">Université de Leeds</orgName><placeName><settlement type="city">Leeds</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Yorkshire-et-Humber</region></placeName></affiliation></author><author><name sortKey="Hulme, Claire" sort="Hulme, Claire" uniqKey="Hulme C" first="Claire" last="Hulme">Claire Hulme</name><affiliation wicri:level="4"><nlm:aff id="I3">Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Charles Thackrah, 101 Clarendon Road, Leeds, LS2 9LJ, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Charles Thackrah, 101 Clarendon Road, Leeds, LS2 9LJ</wicri:regionArea><orgName type="university">Université de Leeds</orgName><placeName><settlement type="city">Leeds</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Yorkshire-et-Humber</region></placeName></affiliation></author><author><name sortKey="Godfrey, Mary" sort="Godfrey, Mary" uniqKey="Godfrey M" first="Mary" last="Godfrey">Mary Godfrey</name><affiliation wicri:level="4"><nlm:aff id="I4">Centre for Health and Social Care, Leeds Institute of Health Sciences, University of Leeds, Charles Thackrah, 101 Clarendon Rd., Leeds, LS2 9LJ, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Centre for Health and Social Care, Leeds Institute of Health Sciences, University of Leeds, Charles Thackrah, 101 Clarendon Rd., Leeds, LS2 9LJ</wicri:regionArea><orgName type="university">Université de Leeds</orgName><placeName><settlement type="city">Leeds</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Yorkshire-et-Humber</region></placeName></affiliation></author><author><name sortKey="Craddock, Helen L" sort="Craddock, Helen L" uniqKey="Craddock H" first="Helen L" last="Craddock">Helen L. Craddock</name><affiliation wicri:level="4"><nlm:aff id="I5">Leeds Dental Institute, Clarendon Road, University of Leeds, Leeds, LS2 9LU, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Leeds Dental Institute, Clarendon Road, University of Leeds, Leeds, LS2 9LU</wicri:regionArea><orgName type="university">Université de Leeds</orgName><placeName><settlement type="city">Leeds</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Yorkshire-et-Humber</region></placeName></affiliation></author><author><name sortKey="Brunton, Paul A" sort="Brunton, Paul A" uniqKey="Brunton P" first="Paul A" last="Brunton">Paul A. Brunton</name><affiliation wicri:level="4"><nlm:aff id="I5">Leeds Dental Institute, Clarendon Road, University of Leeds, Leeds, LS2 9LU, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Leeds Dental Institute, Clarendon Road, University of Leeds, Leeds, LS2 9LU</wicri:regionArea><orgName type="university">Université de Leeds</orgName><placeName><settlement type="city">Leeds</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Yorkshire-et-Humber</region></placeName></affiliation></author><author><name sortKey="Brown, Sarah" sort="Brown, Sarah" uniqKey="Brown S" first="Sarah" last="Brown">Sarah Brown</name><affiliation wicri:level="4"><nlm:aff id="I1">Clinical Trials Research Unit, University of Leeds, Leeds, LS2 9JT, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Clinical Trials Research Unit, University of Leeds, Leeds, LS2 9JT</wicri:regionArea><orgName type="university">Université de Leeds</orgName><placeName><settlement type="city">Leeds</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Yorkshire-et-Humber</region></placeName></affiliation></author><author><name sortKey="Dillon, Sean" sort="Dillon, Sean" uniqKey="Dillon S" first="Sean" last="Dillon">Sean Dillon</name><affiliation wicri:level="4"><nlm:aff id="I5">Leeds Dental Institute, Clarendon Road, University of Leeds, Leeds, LS2 9LU, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Leeds Dental Institute, Clarendon Road, University of Leeds, Leeds, LS2 9LU</wicri:regionArea><orgName type="university">Université de Leeds</orgName><placeName><settlement type="city">Leeds</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Yorkshire-et-Humber</region></placeName></affiliation></author><author><name sortKey="Dukanovic, Gillian" sort="Dukanovic, Gillian" uniqKey="Dukanovic G" first="Gillian" last="Dukanovic">Gillian Dukanovic</name><affiliation wicri:level="4"><nlm:aff id="I5">Leeds Dental Institute, Clarendon Road, University of Leeds, Leeds, LS2 9LU, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Leeds Dental Institute, Clarendon Road, University of Leeds, Leeds, LS2 9LU</wicri:regionArea><orgName type="university">Université de Leeds</orgName><placeName><settlement type="city">Leeds</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Yorkshire-et-Humber</region></placeName></affiliation></author><author><name sortKey="Fernandez, Catherine" sort="Fernandez, Catherine" uniqKey="Fernandez C" first="Catherine" last="Fernandez">Catherine Fernandez</name><affiliation wicri:level="4"><nlm:aff id="I1">Clinical Trials Research Unit, University of Leeds, Leeds, LS2 9JT, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Clinical Trials Research Unit, University of Leeds, Leeds, LS2 9JT</wicri:regionArea><orgName type="university">Université de Leeds</orgName><placeName><settlement type="city">Leeds</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Yorkshire-et-Humber</region></placeName></affiliation><affiliation wicri:level="4"><nlm:aff id="I7">Dental Translational and Clinical Research Unit (DenTCRU), Leeds Dental Institute, Clarendon Road, University of Leeds, Leeds, LS2 9LU, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Dental Translational and Clinical Research Unit (DenTCRU), Leeds Dental Institute, Clarendon Road, University of Leeds, Leeds, LS2 9LU</wicri:regionArea><orgName type="university">Université de Leeds</orgName><placeName><settlement type="city">Leeds</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Yorkshire-et-Humber</region></placeName></affiliation></author><author><name sortKey="Wright, Jonathan" sort="Wright, Jonathan" uniqKey="Wright J" first="Jonathan" last="Wright">Jonathan Wright</name><affiliation wicri:level="4"><nlm:aff id="I1">Clinical Trials Research Unit, University of Leeds, Leeds, LS2 9JT, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Clinical Trials Research Unit, University of Leeds, Leeds, LS2 9JT</wicri:regionArea><orgName type="university">Université de Leeds</orgName><placeName><settlement type="city">Leeds</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Yorkshire-et-Humber</region></placeName></affiliation></author><author><name sortKey="Collier, Howard" sort="Collier, Howard" uniqKey="Collier H" first="Howard" last="Collier">Howard Collier</name><affiliation wicri:level="4"><nlm:aff id="I1">Clinical Trials Research Unit, University of Leeds, Leeds, LS2 9JT, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Clinical Trials Research Unit, University of Leeds, Leeds, LS2 9JT</wicri:regionArea><orgName type="university">Université de Leeds</orgName><placeName><settlement type="city">Leeds</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Yorkshire-et-Humber</region></placeName></affiliation></author><author><name sortKey="Swithenbank, Shirley" sort="Swithenbank, Shirley" uniqKey="Swithenbank S" first="Shirley" last="Swithenbank">Shirley Swithenbank</name><affiliation wicri:level="4"><nlm:aff id="I6">IMPROVDENT PPI representatives, c/o Leeds Dental Institute, Clarendon Road, University of Leeds, Leeds, LS2 9LU, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>IMPROVDENT PPI representatives, c/o Leeds Dental Institute, Clarendon Road, University of Leeds, Leeds, LS2 9LU</wicri:regionArea><orgName type="university">Université de Leeds</orgName><placeName><settlement type="city">Leeds</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Yorkshire-et-Humber</region></placeName></affiliation></author><author><name sortKey="Lee, Carol" sort="Lee, Carol" uniqKey="Lee C" first="Carol" last="Lee">Carol Lee</name><affiliation wicri:level="4"><nlm:aff id="I6">IMPROVDENT PPI representatives, c/o Leeds Dental Institute, Clarendon Road, University of Leeds, Leeds, LS2 9LU, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>IMPROVDENT PPI representatives, c/o Leeds Dental Institute, Clarendon Road, University of Leeds, Leeds, LS2 9LU</wicri:regionArea><orgName type="university">Université de Leeds</orgName><placeName><settlement type="city">Leeds</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Yorkshire-et-Humber</region></placeName></affiliation></author><author><name sortKey="Hyde, T Paul" sort="Hyde, T Paul" uniqKey="Hyde T" first="T Paul" last="Hyde">T Paul Hyde</name><affiliation wicri:level="4"><nlm:aff id="I5">Leeds Dental Institute, Clarendon Road, University of Leeds, Leeds, LS2 9LU, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Leeds Dental Institute, Clarendon Road, University of Leeds, Leeds, LS2 9LU</wicri:regionArea><orgName type="university">Université de Leeds</orgName><placeName><settlement type="city">Leeds</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Yorkshire-et-Humber</region></placeName></affiliation></author></analytic><series><title level="j">BMC Oral Health</title><idno type="eISSN">1472-6831</idno><imprint><date when="2012">2012</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>According to the UK Adult Dental Health Survey (2009) 15% of adults aged 65–74, 30% aged 75–84 and 47% aged >85 years are edentulous and require complete dentures. Patients’ quality of life and nutrition status are affected by poor dentures. The quality of the dental impression is the most important issue for improving the fit and comfort of new dentures. There is paucity of RCT evidence for which impression material is best for complete dentures construction. This study aims to compare two impression materials for effectiveness and cost effectiveness.</p></sec><sec><title>Methods/Design</title><p>IMPROVDENT is a double-blind crossover trial comparing the use of alginate and silicone, two commonly used denture impression materials, in terms of patient preference and cost-effectiveness. Eighty five edentulous patients will be recruited and provided with two sets of dentures, similar in all aspects except for the impression material used (alginate or silicone). Patients will try both sets of dentures for a two-week period, unadjusted, to become accustomed to the feel of the new dentures (habituation period). Patients will then wear each set of dentures for a period of 8 weeks (in random order) during which time the dentures will be adjusted for optimum comfort. Finally, patients will be given both sets of dentures for a further two weeks to wear whichever denture they prefer (confirmation period).</p><p>Patients will be asked about quality of life and to rate dentures on function and comfort at the end of each trial period and asked which set they prefer at the end of the habituation period (unadjusted denture preference) and confirmation period (adjusted denture preference). A health economic evaluation will estimate incremental cost-effectiveness ratios of producing dentures from the two materials. A qualitative study will investigate the impact of dentures on behaviour and quality of life.</p><p>Funding: IMPROVDENT is funded by NIHR RfPB (PB-PG-0408-16300).</p></sec><sec><title>Discussion</title><p>This trial aims to provide evidence on the costs and quality of dentures cast from two different commonly used impression materials; the intention is to significantly impact on the quality of denture production within NHS dentistry.</p></sec><sec><title>Trial Registration</title><p>ISRCTN Register: ISRCTN01528038</p><p>UKCRN Portfolio ID: 8305</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Fuller, E" uniqKey="Fuller E">E Fuller</name></author><author><name sortKey="Steele, J" uniqKey="Steele J">J Steele</name></author><author><name sortKey="Watt, R" uniqKey="Watt R">R Watt</name></author><author><name sortKey="Nuttall, N" uniqKey="Nuttall N">N 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<front><journal-meta><journal-id journal-id-type="nlm-ta">BMC Oral Health</journal-id><journal-id journal-id-type="iso-abbrev">BMC Oral Health</journal-id><journal-title-group><journal-title>BMC Oral Health</journal-title></journal-title-group><issn pub-type="epub">1472-6831</issn><publisher><publisher-name>BioMed Central</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">22937901</article-id><article-id pub-id-type="pmc">3532377</article-id><article-id pub-id-type="publisher-id">1472-6831-12-37</article-id><article-id pub-id-type="doi">10.1186/1472-6831-12-37</article-id><article-categories><subj-group subj-group-type="heading"><subject>Study Protocol</subject></subj-group></article-categories><title-group><article-title>Improvdent: Improving dentures for patient benefit. A crossover randomised clinical trial comparing impression materials for complete dentures</article-title></title-group><contrib-group><contrib contrib-type="author" id="A1"><name><surname>Gray</surname><given-names>Janine C</given-names></name><xref ref-type="aff" rid="I1">1</xref><email>j.c.gray@leeds.ac.uk</email></contrib><contrib contrib-type="author" id="A2"><name><surname>Navarro-Coy</surname><given-names>Nuria</given-names></name><xref ref-type="aff" rid="I1">1</xref><email>n.navarro-coy@leeds.ac.uk</email></contrib><contrib contrib-type="author" id="A3"><name><surname>Pavitt</surname><given-names>Sue H</given-names></name><xref ref-type="aff" rid="I2">2</xref><email>s.pavitt@leeds.ac.uk</email></contrib><contrib contrib-type="author" id="A4"><name><surname>Hulme</surname><given-names>Claire</given-names></name><xref ref-type="aff" rid="I3">3</xref><email>c.t.hulme@leeds.ac.uk</email></contrib><contrib contrib-type="author" id="A5"><name><surname>Godfrey</surname><given-names>Mary</given-names></name><xref ref-type="aff" rid="I4">4</xref><email>m.godfrey@leeds.ac.uk</email></contrib><contrib contrib-type="author" id="A6"><name><surname>Craddock</surname><given-names>Helen L</given-names></name><xref ref-type="aff" rid="I5">5</xref><email>h.l.craddock@leeds.ac.uk</email></contrib><contrib contrib-type="author" id="A7"><name><surname>Brunton</surname><given-names>Paul A</given-names></name><xref ref-type="aff" rid="I5">5</xref><email>p.a.brunton@leeds.ac.uk</email></contrib><contrib contrib-type="author" id="A8"><name><surname>Brown</surname><given-names>Sarah</given-names></name><xref ref-type="aff" rid="I1">1</xref><email>medsbro@leeds.ac.uk</email></contrib><contrib contrib-type="author" id="A9"><name><surname>Dillon</surname><given-names>Sean</given-names></name><xref ref-type="aff" rid="I5">5</xref><email>s.dillon@leeds.ac.uk</email></contrib><contrib contrib-type="author" id="A10"><name><surname>Dukanovic</surname><given-names>Gillian</given-names></name><xref ref-type="aff" rid="I5">5</xref><email>g.dukanovic@leeds.ac.uk</email></contrib><contrib contrib-type="author" id="A11"><name><surname>Fernandez</surname><given-names>Catherine</given-names></name><xref ref-type="aff" rid="I1">1</xref><xref ref-type="aff" rid="I7">7</xref><email>c.fernandez@leeds.ac.uk</email></contrib><contrib contrib-type="author" id="A12"><name><surname>Wright</surname><given-names>Jonathan</given-names></name><xref ref-type="aff" rid="I1">1</xref><email>j.wright@leeds.ac.uk</email></contrib><contrib contrib-type="author" id="A13"><name><surname>Collier</surname><given-names>Howard</given-names></name><xref ref-type="aff" rid="I1">1</xref><email>h.a.collier@leeds.ac.uk</email></contrib><contrib contrib-type="author" id="A14"><name><surname>Swithenbank</surname><given-names>Shirley</given-names></name><xref ref-type="aff" rid="I6">6</xref><email>shirley6337@hotmail.co.uk</email></contrib><contrib contrib-type="author" id="A15"><name><surname>Lee</surname><given-names>Carol</given-names></name><xref ref-type="aff" rid="I6">6</xref><email>ctru_improvdent@leeds.ac.uk</email></contrib><contrib contrib-type="author" corresp="yes" id="A16"><name><surname>Hyde</surname><given-names>T Paul</given-names></name><xref ref-type="aff" rid="I5">5</xref><email>t.p.hyde@leeds.ac.uk</email></contrib></contrib-group><aff id="I1"><label>1</label>Clinical Trials Research Unit, University of Leeds, Leeds, LS2 9JT, UK</aff><aff id="I2"><label>2</label>Centre for Health Sciences Research, Leeds Institute of Health Sciences, University of Leeds, Charles Thackrah, 101 Clarendon Road, Leeds, LS2 9LJ, UK</aff><aff id="I3"><label>3</label>Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Charles Thackrah, 101 Clarendon Road, Leeds, LS2 9LJ, UK</aff><aff id="I4"><label>4</label>Centre for Health and Social Care, Leeds Institute of Health Sciences, University of Leeds, Charles Thackrah, 101 Clarendon Rd., Leeds, LS2 9LJ, UK</aff><aff id="I5"><label>5</label>Leeds Dental Institute, Clarendon Road, University of Leeds, Leeds, LS2 9LU, UK</aff><aff id="I6"><label>6</label>IMPROVDENT PPI representatives, c/o Leeds Dental Institute, Clarendon Road, University of Leeds, Leeds, LS2 9LU, UK</aff><aff id="I7"><label>7</label>Dental Translational and Clinical Research Unit (DenTCRU), Leeds Dental Institute, Clarendon Road, University of Leeds, Leeds, LS2 9LU, UK</aff><pub-date pub-type="collection"><year>2012</year></pub-date><pub-date pub-type="epub"><day>31</day><month>8</month><year>2012</year></pub-date><volume>12</volume><fpage>37</fpage><lpage>37</lpage><history><date date-type="received"><day>1</day><month>6</month><year>2012</year></date><date date-type="accepted"><day>6</day><month>7</month><year>2012</year></date></history><permissions><copyright-statement>Copyright ©2012 Gray et al.; licensee BioMed Central Ltd.</copyright-statement><copyright-year>2012</copyright-year><copyright-holder>Gray et al.; licensee BioMed Central Ltd.</copyright-holder><license license-type="open-access" xlink:href="http://creativecommons.org/licenses/by/2.0"><license-p>This is an Open Access article distributed under the terms of the Creative Commons Attribution License (
<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by/2.0">http://creativecommons.org/licenses/by/2.0</ext-link>), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</license-p></license></permissions><self-uri xlink:href="http://www.biomedcentral.com/1472-6831/12/37"></self-uri><abstract><sec><title>Background</title><p>According to the UK Adult Dental Health Survey (2009) 15% of adults aged 65–74, 30% aged 75–84 and 47% aged >85 years are edentulous and require complete dentures. Patients’ quality of life and nutrition status are affected by poor dentures. The quality of the dental impression is the most important issue for improving the fit and comfort of new dentures. There is paucity of RCT evidence for which impression material is best for complete dentures construction. This study aims to compare two impression materials for effectiveness and cost effectiveness.</p></sec><sec><title>Methods/Design</title><p>IMPROVDENT is a double-blind crossover trial comparing the use of alginate and silicone, two commonly used denture impression materials, in terms of patient preference and cost-effectiveness. Eighty five edentulous patients will be recruited and provided with two sets of dentures, similar in all aspects except for the impression material used (alginate or silicone). Patients will try both sets of dentures for a two-week period, unadjusted, to become accustomed to the feel of the new dentures (habituation period). Patients will then wear each set of dentures for a period of 8 weeks (in random order) during which time the dentures will be adjusted for optimum comfort. Finally, patients will be given both sets of dentures for a further two weeks to wear whichever denture they prefer (confirmation period).</p><p>Patients will be asked about quality of life and to rate dentures on function and comfort at the end of each trial period and asked which set they prefer at the end of the habituation period (unadjusted denture preference) and confirmation period (adjusted denture preference). A health economic evaluation will estimate incremental cost-effectiveness ratios of producing dentures from the two materials. A qualitative study will investigate the impact of dentures on behaviour and quality of life.</p><p>Funding: IMPROVDENT is funded by NIHR RfPB (PB-PG-0408-16300).</p></sec><sec><title>Discussion</title><p>This trial aims to provide evidence on the costs and quality of dentures cast from two different commonly used impression materials; the intention is to significantly impact on the quality of denture production within NHS dentistry.</p></sec><sec><title>Trial Registration</title><p>ISRCTN Register: ISRCTN01528038</p><p>UKCRN Portfolio ID: 8305</p></sec></abstract><kwd-group><kwd>Complete dentures</kwd><kwd>Edentulous</kwd><kwd>Impression material</kwd><kwd>Cost-effectiveness</kwd><kwd>Crossover trial</kwd></kwd-group></article-meta></front></pmc><affiliations><list><country><li>Royaume-Uni</li></country><region><li>Angleterre</li><li>Yorkshire-et-Humber</li></region><settlement><li>Leeds</li></settlement><orgName><li>Université de Leeds</li></orgName></list><tree><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Gray, Janine C" sort="Gray, Janine C" uniqKey="Gray J" first="Janine C" last="Gray">Janine C. Gray</name></region><name sortKey="Brown, Sarah" sort="Brown, Sarah" uniqKey="Brown S" first="Sarah" last="Brown">Sarah Brown</name><name sortKey="Brunton, Paul A" sort="Brunton, Paul A" uniqKey="Brunton P" first="Paul A" last="Brunton">Paul A. Brunton</name><name sortKey="Collier, Howard" sort="Collier, Howard" uniqKey="Collier H" first="Howard" last="Collier">Howard Collier</name><name sortKey="Craddock, Helen L" sort="Craddock, Helen L" uniqKey="Craddock H" first="Helen L" last="Craddock">Helen L. Craddock</name><name sortKey="Dillon, Sean" sort="Dillon, Sean" uniqKey="Dillon S" first="Sean" last="Dillon">Sean Dillon</name><name sortKey="Dukanovic, Gillian" sort="Dukanovic, Gillian" uniqKey="Dukanovic G" first="Gillian" last="Dukanovic">Gillian Dukanovic</name><name sortKey="Fernandez, Catherine" sort="Fernandez, Catherine" uniqKey="Fernandez C" first="Catherine" last="Fernandez">Catherine Fernandez</name><name sortKey="Fernandez, Catherine" sort="Fernandez, Catherine" uniqKey="Fernandez C" first="Catherine" last="Fernandez">Catherine Fernandez</name><name sortKey="Godfrey, Mary" sort="Godfrey, Mary" uniqKey="Godfrey M" first="Mary" last="Godfrey">Mary Godfrey</name><name sortKey="Hulme, Claire" sort="Hulme, Claire" uniqKey="Hulme C" first="Claire" last="Hulme">Claire Hulme</name><name sortKey="Hyde, T Paul" sort="Hyde, T Paul" uniqKey="Hyde T" first="T Paul" last="Hyde">T Paul Hyde</name><name sortKey="Lee, Carol" sort="Lee, Carol" uniqKey="Lee C" first="Carol" last="Lee">Carol Lee</name><name sortKey="Navarro Coy, Nuria" sort="Navarro Coy, Nuria" uniqKey="Navarro Coy N" first="Nuria" last="Navarro-Coy">Nuria Navarro-Coy</name><name sortKey="Pavitt, Sue H" sort="Pavitt, Sue H" uniqKey="Pavitt S" first="Sue H" last="Pavitt">Sue H. Pavitt</name><name sortKey="Swithenbank, Shirley" sort="Swithenbank, Shirley" uniqKey="Swithenbank S" first="Shirley" last="Swithenbank">Shirley Swithenbank</name><name sortKey="Wright, Jonathan" sort="Wright, Jonathan" uniqKey="Wright J" first="Jonathan" last="Wright">Jonathan Wright</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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