A Randomised Controlled Trial of complete denture impression materials
Identifieur interne : 001678 ( Pmc/Checkpoint ); précédent : 001677; suivant : 001679A Randomised Controlled Trial of complete denture impression materials
Auteurs : T. P. Hyde [Royaume-Uni] ; H. L. Craddock [Royaume-Uni] ; J. C. Gray [Royaume-Uni] ; S. H. Pavitt [Royaume-Uni] ; C. Hulme [Royaume-Uni] ; M. Godfrey [Royaume-Uni] ; C. Fernandez [Royaume-Uni] ; N. Navarro-Coy [Royaume-Uni] ; S. Dillon [Royaume-Uni] ; J. Wright [Royaume-Uni] ; S. Brown [Royaume-Uni] ; G. Dukanovic [Royaume-Uni] ; P. A. Brunton [Royaume-Uni, Nouvelle-Zélande]Source :
- Journal of Dentistry [ 0300-5712 ] ; 2014.
Abstract
There is continuing demand for non-implant prosthodontic treatment and yet there is a paucity of high quality Randomised Controlled Trial (RCT) evidence for best practice. The aim of this research was to provide evidence for best practice in prosthodontic impressions by comparing two impression materials in a double-blind, randomised, crossover, controlled, clinical trial.
Eighty-five patients were recruited, using published eligibility criteria, to the trial at Leeds Dental Institute, UK. Each patient received two sets of dentures; made using either alginate or silicone impressions. Randomisations determined the order of assessment and order of impressions. The primary outcome was patient blinded preference for unadjusted dentures. Secondary outcomes were patient preference for the adjusted dentures, rating of comfort, stability and chewing efficiency, experience of each impression, and an OHIP-EDENT questionnaire.
Seventy-eight (91.8%) patients completed the primary assessment. 53(67.9%) patients preferred dentures made from silicone impressions while 14(17.9%) preferred alginate impressions. 4(5.1%) patients found both dentures equally satisfactory and 7 (9.0%) found both equally unsatisfactory. There was a 50% difference in preference rates (in favour of silicone) (95%CI 32.7–67.3%,
There is significant evidence that dentures made from silicone impressions were preferred by patients.
Given the strength of the clinical findings within this paper, dentists should consider choosing silicone rather than alginate as their material of choice for secondary impressions for complete dentures.
Trial Registration: ISRCTN 01528038.
This article forms part of a project for which the author (TPH) won the Senior Clinical Unilever Hatton Award of the International Assocation for Dental Research, Capetown, South Africa, June 2014.
Url:
DOI: 10.1016/j.jdent.2014.02.005
PubMed: 24995473
PubMed Central: 4119301
Affiliations:
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">A Randomised Controlled Trial of complete denture impression materials</title><author><name sortKey="Hyde, T P" sort="Hyde, T P" uniqKey="Hyde T" first="T. P." last="Hyde">T. P. Hyde</name><affiliation wicri:level="4"><nlm:aff id="aff0040">Leeds Dental Institute, University of Leeds, Leeds LS2 9LU, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Leeds Dental Institute, 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="Craddock, H L" sort="Craddock, H L" uniqKey="Craddock H" first="H. L." last="Craddock">H. L. Craddock</name><affiliation wicri:level="1"><nlm:aff id="aff0005">University of Aberdeen Dental School, Cornhill Road, Aberdeen AB25 2ZR, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>University of Aberdeen Dental School, Cornhill Road, Aberdeen AB25 2ZR</wicri:regionArea><wicri:noRegion>Aberdeen AB25 2ZR</wicri:noRegion></affiliation></author><author><name sortKey="Gray, J C" sort="Gray, J C" uniqKey="Gray J" first="J. C." last="Gray">J. C. Gray</name><affiliation wicri:level="4"><nlm:aff id="aff0010">Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds LS2 9JT, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, 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, S H" sort="Pavitt, S H" uniqKey="Pavitt S" first="S. H." last="Pavitt">S. H. Pavitt</name><affiliation wicri:level="4"><nlm:aff id="aff0015">Applied Health Research, Leeds Institute of Health Sciences, University of Leeds, Leeds LS2 9LJ, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Applied Health Research, Leeds Institute of Health Sciences, University of Leeds, 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, C" sort="Hulme, C" uniqKey="Hulme C" first="C." last="Hulme">C. Hulme</name><affiliation wicri:level="4"><nlm:aff id="aff0020">Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, 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, 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, M" sort="Godfrey, M" uniqKey="Godfrey M" first="M." last="Godfrey">M. Godfrey</name><affiliation wicri:level="1"><nlm:aff id="aff0025">Health and Social Care, Leeds Institute of Health Sciences, Leeds LS2 9LJ, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Health and Social Care, Leeds Institute of Health Sciences, Leeds LS2 9LJ</wicri:regionArea><wicri:noRegion>Leeds LS2 9LJ</wicri:noRegion></affiliation></author><author><name sortKey="Fernandez, C" sort="Fernandez, C" uniqKey="Fernandez C" first="C." last="Fernandez">C. Fernandez</name><affiliation wicri:level="4"><nlm:aff id="aff0010">Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds LS2 9JT, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, 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, N" sort="Navarro Coy, N" uniqKey="Navarro Coy N" first="N." last="Navarro-Coy">N. Navarro-Coy</name><affiliation wicri:level="4"><nlm:aff id="aff0035">Leeds Institute of Clinical Trials Research, University of Leeds, Leeds LS2 9JT, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Leeds Institute of Clinical Trials Research, 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, S" sort="Dillon, S" uniqKey="Dillon S" first="S." last="Dillon">S. Dillon</name><affiliation wicri:level="4"><nlm:aff id="aff0040">Leeds Dental Institute, University of Leeds, Leeds LS2 9LU, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Leeds Dental Institute, 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, J" sort="Wright, J" uniqKey="Wright J" first="J." last="Wright">J. Wright</name><affiliation wicri:level="4"><nlm:aff id="aff0035">Leeds Institute of Clinical Trials Research, University of Leeds, Leeds LS2 9JT, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Leeds Institute of Clinical Trials Research, 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="Brown, S" sort="Brown, S" uniqKey="Brown S" first="S." last="Brown">S. Brown</name><affiliation wicri:level="4"><nlm:aff id="aff0010">Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds LS2 9JT, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, 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="Dukanovic, G" sort="Dukanovic, G" uniqKey="Dukanovic G" first="G." last="Dukanovic">G. Dukanovic</name><affiliation wicri:level="4"><nlm:aff id="aff0045">Dental Translational Clinical Research Unit (DenTCRU), Leeds Dental institute, University of Leeds, Leeds LS2 9LU, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Dental Translational Clinical Research Unit (DenTCRU), Leeds Dental institute, 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, P A" sort="Brunton, P A" uniqKey="Brunton P" first="P. A." last="Brunton">P. A. Brunton</name><affiliation wicri:level="4"><nlm:aff id="aff0040">Leeds Dental Institute, University of Leeds, Leeds LS2 9LU, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Leeds Dental Institute, 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><affiliation wicri:level="1"><nlm:aff id="aff0050">Faculty of Dentistry, University of Otago, Dunedin, New Zealand</nlm:aff><country xml:lang="fr">Nouvelle-Zélande</country><wicri:regionArea>Faculty of Dentistry, University of Otago, Dunedin</wicri:regionArea><wicri:noRegion>Dunedin</wicri:noRegion></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">24995473</idno><idno type="pmc">4119301</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4119301</idno><idno type="RBID">PMC:4119301</idno><idno type="doi">10.1016/j.jdent.2014.02.005</idno><date when="2014">2014</date><idno type="wicri:Area/Pmc/Corpus">003127</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">003127</idno><idno type="wicri:Area/Pmc/Curation">003127</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">003127</idno><idno type="wicri:Area/Pmc/Checkpoint">001678</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Checkpoint">001678</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">A Randomised Controlled Trial of complete denture impression materials</title><author><name sortKey="Hyde, T P" sort="Hyde, T P" uniqKey="Hyde T" first="T. P." last="Hyde">T. P. Hyde</name><affiliation wicri:level="4"><nlm:aff id="aff0040">Leeds Dental Institute, University of Leeds, Leeds LS2 9LU, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Leeds Dental Institute, 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="Craddock, H L" sort="Craddock, H L" uniqKey="Craddock H" first="H. L." last="Craddock">H. L. Craddock</name><affiliation wicri:level="1"><nlm:aff id="aff0005">University of Aberdeen Dental School, Cornhill Road, Aberdeen AB25 2ZR, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>University of Aberdeen Dental School, Cornhill Road, Aberdeen AB25 2ZR</wicri:regionArea><wicri:noRegion>Aberdeen AB25 2ZR</wicri:noRegion></affiliation></author><author><name sortKey="Gray, J C" sort="Gray, J C" uniqKey="Gray J" first="J. C." last="Gray">J. C. Gray</name><affiliation wicri:level="4"><nlm:aff id="aff0010">Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds LS2 9JT, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, 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, S H" sort="Pavitt, S H" uniqKey="Pavitt S" first="S. H." last="Pavitt">S. H. Pavitt</name><affiliation wicri:level="4"><nlm:aff id="aff0015">Applied Health Research, Leeds Institute of Health Sciences, University of Leeds, Leeds LS2 9LJ, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Applied Health Research, Leeds Institute of Health Sciences, University of Leeds, 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, C" sort="Hulme, C" uniqKey="Hulme C" first="C." last="Hulme">C. Hulme</name><affiliation wicri:level="4"><nlm:aff id="aff0020">Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, 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, 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, M" sort="Godfrey, M" uniqKey="Godfrey M" first="M." last="Godfrey">M. Godfrey</name><affiliation wicri:level="1"><nlm:aff id="aff0025">Health and Social Care, Leeds Institute of Health Sciences, Leeds LS2 9LJ, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Health and Social Care, Leeds Institute of Health Sciences, Leeds LS2 9LJ</wicri:regionArea><wicri:noRegion>Leeds LS2 9LJ</wicri:noRegion></affiliation></author><author><name sortKey="Fernandez, C" sort="Fernandez, C" uniqKey="Fernandez C" first="C." last="Fernandez">C. Fernandez</name><affiliation wicri:level="4"><nlm:aff id="aff0010">Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds LS2 9JT, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, 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, N" sort="Navarro Coy, N" uniqKey="Navarro Coy N" first="N." last="Navarro-Coy">N. Navarro-Coy</name><affiliation wicri:level="4"><nlm:aff id="aff0035">Leeds Institute of Clinical Trials Research, University of Leeds, Leeds LS2 9JT, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Leeds Institute of Clinical Trials Research, 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, S" sort="Dillon, S" uniqKey="Dillon S" first="S." last="Dillon">S. Dillon</name><affiliation wicri:level="4"><nlm:aff id="aff0040">Leeds Dental Institute, University of Leeds, Leeds LS2 9LU, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Leeds Dental Institute, 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, J" sort="Wright, J" uniqKey="Wright J" first="J." last="Wright">J. Wright</name><affiliation wicri:level="4"><nlm:aff id="aff0035">Leeds Institute of Clinical Trials Research, University of Leeds, Leeds LS2 9JT, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Leeds Institute of Clinical Trials Research, 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="Brown, S" sort="Brown, S" uniqKey="Brown S" first="S." last="Brown">S. Brown</name><affiliation wicri:level="4"><nlm:aff id="aff0010">Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds LS2 9JT, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, 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="Dukanovic, G" sort="Dukanovic, G" uniqKey="Dukanovic G" first="G." last="Dukanovic">G. Dukanovic</name><affiliation wicri:level="4"><nlm:aff id="aff0045">Dental Translational Clinical Research Unit (DenTCRU), Leeds Dental institute, University of Leeds, Leeds LS2 9LU, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Dental Translational Clinical Research Unit (DenTCRU), Leeds Dental institute, 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, P A" sort="Brunton, P A" uniqKey="Brunton P" first="P. A." last="Brunton">P. A. Brunton</name><affiliation wicri:level="4"><nlm:aff id="aff0040">Leeds Dental Institute, University of Leeds, Leeds LS2 9LU, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Leeds Dental Institute, 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><affiliation wicri:level="1"><nlm:aff id="aff0050">Faculty of Dentistry, University of Otago, Dunedin, New Zealand</nlm:aff><country xml:lang="fr">Nouvelle-Zélande</country><wicri:regionArea>Faculty of Dentistry, University of Otago, Dunedin</wicri:regionArea><wicri:noRegion>Dunedin</wicri:noRegion></affiliation></author></analytic><series><title level="j">Journal of Dentistry</title><idno type="ISSN">0300-5712</idno><idno type="eISSN">1879-176X</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Objectives</title><p>There is continuing demand for non-implant prosthodontic treatment and yet there is a paucity of high quality Randomised Controlled Trial (RCT) evidence for best practice. The aim of this research was to provide evidence for best practice in prosthodontic impressions by comparing two impression materials in a double-blind, randomised, crossover, controlled, clinical trial.</p></sec><sec><title>Methods</title><p>Eighty-five patients were recruited, using published eligibility criteria, to the trial at Leeds Dental Institute, UK. Each patient received two sets of dentures; made using either alginate or silicone impressions. Randomisations determined the order of assessment and order of impressions. The primary outcome was patient blinded preference for unadjusted dentures. Secondary outcomes were patient preference for the adjusted dentures, rating of comfort, stability and chewing efficiency, experience of each impression, and an OHIP-EDENT questionnaire.</p></sec><sec><title>Results</title><p>Seventy-eight (91.8%) patients completed the primary assessment. 53(67.9%) patients preferred dentures made from silicone impressions while 14(17.9%) preferred alginate impressions. 4(5.1%) patients found both dentures equally satisfactory and 7 (9.0%) found both equally unsatisfactory. There was a 50% difference in preference rates (in favour of silicone) (95%CI 32.7–67.3%, <italic>p</italic> < 0.0001).</p></sec><sec><title>Conclusion</title><p>There is significant evidence that dentures made from silicone impressions were preferred by patients.</p></sec><sec><title>Clinical significance</title><p>Given the strength of the clinical findings within this paper, dentists should consider choosing silicone rather than alginate as their material of choice for secondary impressions for complete dentures.</p><p>Trial Registration: ISRCTN 01528038.
</p><p>This article forms part of a project for which the author (TPH) won the Senior Clinical Unilever Hatton Award of the International Assocation for Dental Research, Capetown, South Africa, June 2014.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Muller, F" uniqKey="Muller F">F. Müller</name></author><author><name sortKey="Salem, K" uniqKey="Salem K">K. Salem</name></author><author><name sortKey="Barbezat, C" uniqKey="Barbezat C">C. Barbezat</name></author><author><name sortKey="Herrmann, F R" uniqKey="Herrmann F">F.R. Herrmann</name></author><author><name sortKey="Schimmel, M" uniqKey="Schimmel M">M. Schimmel</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Ellis, J S" uniqKey="Ellis J">J.S. Ellis</name></author><author><name sortKey="Levine, A" uniqKey="Levine A">A. Levine</name></author><author><name sortKey="Bedos, C" uniqKey="Bedos C">C. 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<front><journal-meta><journal-id journal-id-type="nlm-ta">J Dent</journal-id><journal-id journal-id-type="iso-abbrev">J Dent</journal-id><journal-title-group><journal-title>Journal of Dentistry</journal-title></journal-title-group><issn pub-type="ppub">0300-5712</issn><issn pub-type="epub">1879-176X</issn><publisher><publisher-name>Elsevier</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">24995473</article-id><article-id pub-id-type="pmc">4119301</article-id><article-id pub-id-type="publisher-id">S0300-5712(14)00053-0</article-id><article-id pub-id-type="doi">10.1016/j.jdent.2014.02.005</article-id><article-categories><subj-group subj-group-type="heading"><subject>Article</subject></subj-group></article-categories><title-group><article-title>A Randomised Controlled Trial of complete denture impression materials</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Hyde</surname><given-names>T.P.</given-names></name><email>t.p.hyde@leeds.ac.uk</email><xref rid="aff0040" ref-type="aff">a</xref><xref rid="cor0005" ref-type="corresp">⁎</xref></contrib><contrib contrib-type="author"><name><surname>Craddock</surname><given-names>H.L.</given-names></name><xref rid="aff0005" ref-type="aff">b</xref></contrib><contrib contrib-type="author"><name><surname>Gray</surname><given-names>J.C.</given-names></name><xref rid="aff0010" ref-type="aff">c</xref></contrib><contrib contrib-type="author"><name><surname>Pavitt</surname><given-names>S.H.</given-names></name><xref rid="aff0015" ref-type="aff">d</xref></contrib><contrib contrib-type="author"><name><surname>Hulme</surname><given-names>C.</given-names></name><xref rid="aff0020" ref-type="aff">e</xref></contrib><contrib contrib-type="author"><name><surname>Godfrey</surname><given-names>M.</given-names></name><xref rid="aff0025" ref-type="aff">f</xref></contrib><contrib contrib-type="author"><name><surname>Fernandez</surname><given-names>C.</given-names></name><xref rid="aff0010" ref-type="aff">c</xref></contrib><contrib contrib-type="author"><name><surname>Navarro-Coy</surname><given-names>N.</given-names></name><xref rid="aff0035" ref-type="aff">g</xref></contrib><contrib contrib-type="author"><name><surname>Dillon</surname><given-names>S.</given-names></name><xref rid="aff0040" ref-type="aff">a</xref></contrib><contrib contrib-type="author"><name><surname>Wright</surname><given-names>J.</given-names></name><xref rid="aff0035" ref-type="aff">g</xref></contrib><contrib contrib-type="author"><name><surname>Brown</surname><given-names>S.</given-names></name><xref rid="aff0010" ref-type="aff">c</xref></contrib><contrib contrib-type="author"><name><surname>Dukanovic</surname><given-names>G.</given-names></name><xref rid="aff0045" ref-type="aff">h</xref></contrib><contrib contrib-type="author"><name><surname>Brunton</surname><given-names>P.A.</given-names></name><xref rid="aff0040" ref-type="aff">a</xref><xref rid="aff0050" ref-type="aff">i</xref></contrib></contrib-group><aff id="aff0040"><label>a</label>Leeds Dental Institute, University of Leeds, Leeds LS2 9LU, UK</aff><aff id="aff0005"><label>b</label>University of Aberdeen Dental School, Cornhill Road, Aberdeen AB25 2ZR, UK</aff><aff id="aff0010"><label>c</label>Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds LS2 9JT, UK</aff><aff id="aff0015"><label>d</label>Applied Health Research, Leeds Institute of Health Sciences, University of Leeds, Leeds LS2 9LJ, UK</aff><aff id="aff0020"><label>e</label>Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds LS2 9LJ, UK</aff><aff id="aff0025"><label>f</label>Health and Social Care, Leeds Institute of Health Sciences, Leeds LS2 9LJ, UK</aff><aff id="aff0035"><label>g</label>Leeds Institute of Clinical Trials Research, University of Leeds, Leeds LS2 9JT, UK</aff><aff id="aff0045"><label>h</label>Dental Translational Clinical Research Unit (DenTCRU), Leeds Dental institute, University of Leeds, Leeds LS2 9LU, UK</aff><aff id="aff0050"><label>i</label>Faculty of Dentistry, University of Otago, Dunedin, New Zealand</aff><author-notes><corresp id="cor0005"><label>⁎</label><italic>Corresponding author</italic>. Tel.: +44 113 343 8515. <email>t.p.hyde@leeds.ac.uk</email></corresp></author-notes><pub-date pub-type="pmc-release"><day>1</day><month>8</month><year>2014</year></pub-date><pmc-comment> PMC Release delay is 0 months and 0 days and was based on .</pmc-comment>
<pub-date pub-type="ppub"><month>8</month><year>2014</year></pub-date><volume>42</volume><issue>8</issue><fpage>895</fpage><lpage>901</lpage><history><date date-type="received"><day>2</day><month>10</month><year>2013</year></date><date date-type="rev-recd"><day>7</day><month>2</month><year>2014</year></date><date date-type="accepted"><day>11</day><month>2</month><year>2014</year></date></history><permissions><copyright-statement>© 2014 The Authors</copyright-statement><copyright-year>2014</copyright-year><license license-type="CC BY-NC-SA" xlink:href="http://creativecommons.org/licenses/by-nc-sa/3.0/"><license-p>This is an open access article under the CC BY-NC-SA license (http://creativecommons.org/licenses/by-nc-sa/3.0/).</license-p></license></permissions><abstract><sec><title>Objectives</title><p>There is continuing demand for non-implant prosthodontic treatment and yet there is a paucity of high quality Randomised Controlled Trial (RCT) evidence for best practice. The aim of this research was to provide evidence for best practice in prosthodontic impressions by comparing two impression materials in a double-blind, randomised, crossover, controlled, clinical trial.</p></sec><sec><title>Methods</title><p>Eighty-five patients were recruited, using published eligibility criteria, to the trial at Leeds Dental Institute, UK. Each patient received two sets of dentures; made using either alginate or silicone impressions. Randomisations determined the order of assessment and order of impressions. The primary outcome was patient blinded preference for unadjusted dentures. Secondary outcomes were patient preference for the adjusted dentures, rating of comfort, stability and chewing efficiency, experience of each impression, and an OHIP-EDENT questionnaire.</p></sec><sec><title>Results</title><p>Seventy-eight (91.8%) patients completed the primary assessment. 53(67.9%) patients preferred dentures made from silicone impressions while 14(17.9%) preferred alginate impressions. 4(5.1%) patients found both dentures equally satisfactory and 7 (9.0%) found both equally unsatisfactory. There was a 50% difference in preference rates (in favour of silicone) (95%CI 32.7–67.3%, <italic>p</italic> < 0.0001).</p></sec><sec><title>Conclusion</title><p>There is significant evidence that dentures made from silicone impressions were preferred by patients.</p></sec><sec><title>Clinical significance</title><p>Given the strength of the clinical findings within this paper, dentists should consider choosing silicone rather than alginate as their material of choice for secondary impressions for complete dentures.</p><p>Trial Registration: ISRCTN 01528038.
</p><p>This article forms part of a project for which the author (TPH) won the Senior Clinical Unilever Hatton Award of the International Assocation for Dental Research, Capetown, South Africa, June 2014.</p></sec></abstract><kwd-group><title>Keywords</title><kwd>Prosthodontics</kwd><kwd>Quality-of life</kwd><kwd>Patient outcomes</kwd><kwd>Impression materials</kwd><kwd>Edentulous</kwd><kwd>Removable prosthodontics</kwd></kwd-group></article-meta></front><floats-group><fig id="fig0005"><label>Fig. 1</label><caption><p>CONSORT flow diagram showing patients progression through the phases of the trial.</p></caption><graphic xlink:href="gr1"></graphic></fig><table-wrap id="tbl0005" position="float"><label>Table 1</label><caption><p>Patient preference of the dentures before and after adjustment.</p></caption><table frame="hsides" rules="groups"><thead><tr><th></th><th colspan="3" align="center">Silicone<hr></hr></th></tr><tr><th></th><th align="center">Prefer/satisfactory</th><th align="center">Not prefer/unsatisfactory</th><th align="center">Total</th></tr></thead><tbody><tr><td colspan="4" align="left"><italic>Patient denture preference before denture adjustment (after Habituation Period)</italic></td></tr><tr><td colspan="4" align="left">Alginate</td></tr><tr><td align="left">Prefer/satisfactory</td><td align="char">4 (5.1%)</td><td align="char">14 (17.9%)</td><td align="char">18 (23.1%)</td></tr><tr><td align="left">Not prefer/unsatisfactory</td><td align="char">53 (67.9%)</td><td align="char">7 (9.0%)</td><td align="char">60 (76.9%)</td></tr><tr><td align="left">Total</td><td align="char">57 (73.1%)</td><td align="char">21 (26.9%)</td><td align="char">78 (100.0%)</td></tr></tbody></table><table frame="hsides" rules="groups"><thead><tr><th></th><th colspan="3" align="center">Silicone<hr></hr></th></tr><tr><th></th><th align="center">Prefer/satisfactory</th><th align="center">Not prefer/unsatisfactory</th><th align="center">Total</th></tr></thead><tbody><tr><td colspan="4" align="left"><italic>Patient denture preference after denture adjustment (after Confirmation Period)</italic></td></tr><tr><td colspan="4" align="left">Alginate</td></tr><tr><td align="left">Prefer/satisfactory</td><td align="char">7 (9.9%)</td><td align="char">17 (23.9%)</td><td align="char">24 (33.8%)</td></tr><tr><td align="left">Not prefer/unsatisfactory</td><td align="char">41 (57.7%)</td><td align="char">6 (8.5%)</td><td align="char">47 (66.2%)</td></tr><tr><td align="left">Total</td><td align="char">48 (67.6%)</td><td align="char">23 (32.4%)</td><td align="char">71 (100.0%)</td></tr></tbody></table></table-wrap><table-wrap id="tbl0010" position="float"><label>Table 2</label><caption><p>Differences in comfort, stability and chewing efficiency of dentures by Likert scores.</p></caption><table frame="hsides" rules="groups"><thead><tr><th align="left">A total of 80 patients reached Habituation</th><th align="center">Comfort <italic>N</italic> (%)</th><th align="center">Stability <italic>N</italic> (%)</th><th align="center">Efficiency <italic>N</italic> (%)</th></tr></thead><tbody><tr><td colspan="4" align="left"><italic>Before denture adjustment (after Habituation Period):</italic></td></tr><tr><td colspan="4" align="left">Difference in score (Silicone–Alginate)</td></tr><tr><td align="left">−4 to −2</td><td align="char">19 (23.8%)</td><td align="char">15 (18.8%)</td><td align="char">18 (22.5%)</td></tr><tr><td align="left">−1</td><td align="char">21 (26.3%)</td><td align="char">16 (20.0%)</td><td align="char">16 (20.0%)</td></tr><tr><td align="left">0</td><td align="char">25 (31.3%)</td><td align="char">38 (47.5%)</td><td align="char">40 (50.0%)</td></tr><tr><td align="left">1</td><td align="char">4 (5.0%)</td><td align="char">3 (3.8%)</td><td align="char">0 (0.0%)</td></tr><tr><td align="left">2–3</td><td align="char">9 (11.3%)</td><td align="char">6 (7.5%)</td><td align="char">4 (5.0%)</td></tr><tr><td align="left">Missing</td><td align="char">2 (2.5%)</td><td align="char">2 (2.5%)</td><td align="char">2 (2.5%)</td></tr><tr><td align="left">Total</td><td align="char">80 (100.0%)</td><td align="char">80 (100.0%)</td><td align="char">80 (100.0%)</td></tr></tbody></table><table frame="hsides" rules="groups"><thead><tr><th align="left">A total of 72 patients reached Confirmation</th><th align="center">Comfort <italic>N</italic> (%)</th><th align="center">Stability <italic>N</italic> (%)</th><th align="center">Efficiency <italic>N</italic> (%)</th></tr></thead><tbody><tr><td colspan="4" align="left"><italic>After denture adjustment (after Confirmation Period):</italic></td></tr><tr><td colspan="4" align="left">Difference in score (Silicone–Alginate)</td></tr><tr><td align="left">−4 to −2</td><td align="char">10 (13.9%)</td><td align="char">10 (13.9%)</td><td align="char">12 (16.7%)</td></tr><tr><td align="left">−1</td><td align="char">12 (16.7%)</td><td align="char">16 (22.2%)</td><td align="char">12 (16.7%)</td></tr><tr><td align="left">0</td><td align="char">30 (41.7%)</td><td align="char">35 (48.6%)</td><td align="char">39 (54.2%)</td></tr><tr><td align="left">1</td><td align="char">12 (16.7%)</td><td align="char">7 (9.7%)</td><td align="char">6 (8.3%)</td></tr><tr><td align="left">2–3</td><td align="char">7 (9.7%)</td><td align="char">3 (4.2%)</td><td align="char">2 (2.8%)</td></tr><tr><td align="left">Missing</td><td align="char">1 (1.4%)</td><td align="char">1 (1.4%)</td><td align="char">1 (1.4%)</td></tr><tr><td align="left">Total</td><td align="char">72 (100.0%)</td><td align="char">72 (100.0%)</td><td align="char">72 (100.0%)</td></tr></tbody></table></table-wrap><table-wrap id="tbl0015" position="float"><label>Table 3</label><caption><p>Overall and domain OHIP-EDENT scores by impression material.</p></caption><table frame="hsides" rules="groups"><thead><tr><th></th><th></th><th align="center">Alginate</th><th align="center">Silicone</th></tr><tr><th></th><th></th><th align="center"><italic>N</italic> = 78</th><th align="center"><italic>N</italic> = 78</th></tr></thead><tbody><tr><td colspan="4" align="left"><italic>Overall OHIP-EDENT score</italic></td></tr><tr><td rowspan="2" align="left">Overall score:</td><td align="left">Median (range)</td><td align="char">38.5 (2, 75)</td><td align="char">27.0 (0, 69)</td></tr><tr><td align="left">Missing</td><td align="char">6</td><td align="char">6</td></tr><tr><td colspan="4" align="left">
</td></tr><tr><td colspan="4" align="left"><italic>Domain OHIP-EDENT score</italic></td></tr><tr><td rowspan="2" align="left">Function limitation:</td><td align="left">Median (range)</td><td align="char">9.0 (0, 12)</td><td align="char">7.0 (0, 12)</td></tr><tr><td align="left">Missing</td><td align="char">5</td><td align="char">5</td></tr><tr><td rowspan="2" align="left">Pain:</td><td align="left">Median (range)</td><td align="char">11.0 (0, 16)</td><td align="char">8.0 (0, 16)</td></tr><tr><td align="left">Missing</td><td align="char">6</td><td align="char">5</td></tr><tr><td rowspan="2" align="left">Psychological discomfort:</td><td align="left">Median (range)</td><td align="char">3.0 (0, 8)</td><td align="char">2.0 (0, 8)</td></tr><tr><td align="left">Missing</td><td align="char">5</td><td align="char">5</td></tr><tr><td rowspan="2" align="left">Physical disability:</td><td align="left">Median (range)</td><td align="char">7.0 (0, 12)</td><td align="char">5.0 (0, 12)</td></tr><tr><td align="left">Missing</td><td align="char">6</td><td align="char">6</td></tr><tr><td rowspan="2" align="left">Psychological disability:</td><td align="left">Median (range)</td><td align="char">2.0 (0, 8)</td><td align="char">2.0 (0, 8)</td></tr><tr><td align="left">Missing</td><td align="char">5</td><td align="char">6</td></tr><tr><td rowspan="2" align="left">Social disability:</td><td align="left">Median (range)</td><td align="char">2.0 (0, 12)</td><td align="char">0.0 (0, 11)</td></tr><tr><td align="left">Missing</td><td align="char">5</td><td align="char">6</td></tr><tr><td rowspan="2" align="left">Handicap:</td><td align="left">Median (range)</td><td align="char">0.0 (0, 8)</td><td align="char">0.0 (0, 8)</td></tr><tr><td align="left">Missing</td><td align="char">5</td><td align="char">6</td></tr></tbody></table></table-wrap></floats-group></pmc><affiliations><list><country><li>Nouvelle-Zélande</li><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="Hyde, T P" sort="Hyde, T P" uniqKey="Hyde T" first="T. P." last="Hyde">T. P. Hyde</name></region><name sortKey="Brown, S" sort="Brown, S" uniqKey="Brown S" first="S." last="Brown">S. Brown</name><name sortKey="Brunton, P A" sort="Brunton, P A" uniqKey="Brunton P" first="P. A." last="Brunton">P. A. Brunton</name><name sortKey="Craddock, H L" sort="Craddock, H L" uniqKey="Craddock H" first="H. L." last="Craddock">H. L. Craddock</name><name sortKey="Dillon, S" sort="Dillon, S" uniqKey="Dillon S" first="S." last="Dillon">S. Dillon</name><name sortKey="Dukanovic, G" sort="Dukanovic, G" uniqKey="Dukanovic G" first="G." last="Dukanovic">G. Dukanovic</name><name sortKey="Fernandez, C" sort="Fernandez, C" uniqKey="Fernandez C" first="C." last="Fernandez">C. Fernandez</name><name sortKey="Godfrey, M" sort="Godfrey, M" uniqKey="Godfrey M" first="M." last="Godfrey">M. Godfrey</name><name sortKey="Gray, J C" sort="Gray, J C" uniqKey="Gray J" first="J. C." last="Gray">J. C. Gray</name><name sortKey="Hulme, C" sort="Hulme, C" uniqKey="Hulme C" first="C." last="Hulme">C. Hulme</name><name sortKey="Navarro Coy, N" sort="Navarro Coy, N" uniqKey="Navarro Coy N" first="N." last="Navarro-Coy">N. Navarro-Coy</name><name sortKey="Pavitt, S H" sort="Pavitt, S H" uniqKey="Pavitt S" first="S. H." last="Pavitt">S. H. Pavitt</name><name sortKey="Wright, J" sort="Wright, J" uniqKey="Wright J" first="J." last="Wright">J. Wright</name></country><country name="Nouvelle-Zélande"><noRegion><name sortKey="Brunton, P A" sort="Brunton, P A" uniqKey="Brunton P" first="P. A." last="Brunton">P. A. Brunton</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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