The effect of nocturnal wear of complete dentures on sleep and oral health related quality of life: study protocol for a randomized controlled trial
Identifieur interne : 000049 ( Pmc/Checkpoint ); précédent : 000048; suivant : 000050The effect of nocturnal wear of complete dentures on sleep and oral health related quality of life: study protocol for a randomized controlled trial
Auteurs : Elham Emami [Canada] ; Phan The Huy Nguyen ; Fernanda R. Almeida ; Jocelyne S. Feine [Canada] ; Igor Karp ; Gilles Lavigne ; Nelly HuynhSource :
- Trials [ 1745-6215 ] ; 2014.
Abstract
Edentulism and sleep disturbance are chronic conditions that are common in older people and have serious adverse consequences for their functioning and quality of life. Edentulism can disturb sleep through the alteration of the craniofacial structure and surrounding soft tissue. However, the effect of prosthetic rehabilitation of edentulism on sleep quality is still not well understood. The objectives of this study are to test whether nocturnal denture wear affects sleep quality, daytime sleepiness, and the oral health related quality of life of edentate older people with moderate to severe sleep apnea, and to identify modifiers of effect of nocturnal denture wear.
We will carry out a single-blind randomized cross-over trial. Seventy edentate older people with moderate to severe obstructive sleep apnea will be enrolled. The study participants will be assigned to wear and not wear their dentures on alternate periods of 30 days. The outcome measures will be sleep quality (assessed by portable polysomnography), daytime sleepiness (assessed by the Epworth Sleepiness Scale), and oral health related quality of life (assessed by validated questionnaire). A number of characteristics (sociodemographic, oropharyngeal morphology, oral and prosthesis characteristics, and perceived general health quality of life) will be assessed by means of clinical examination, 3D imaging of the craniofacial structure, and validated questionnaires at baseline. Linear mixed effects regression models for repeated measures will be fitted to test the study hypotheses. The main analyses will be based on the intention-to-treat principle. To assess the robustness of the findings to potential incomplete adherence, sensitivity analyses will be conducted while applying the per-protocol principle.
This practice-relevant evidence could represent a preventive approach to improve sleep characteristics of the older population and improve their well-being and quality of life.
ClinicalTrials.gov
Url:
DOI: 10.1186/1745-6215-15-358
PubMed: 25218696
PubMed Central: 4177759
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">The effect of nocturnal wear of complete dentures on sleep and oral health related quality of life: study protocol for a randomized controlled trial</title><author><name sortKey="Emami, Elham" sort="Emami, Elham" uniqKey="Emami E" first="Elham" last="Emami">Elham Emami</name><affiliation><nlm:aff id="Aff1">Faculty of Dentistry, Université de Montréal, 2900 Edouard-Montpetit, Montreal, QC H3T 1J4 Canada</nlm:aff><wicri:noCountry code="subfield">QC H3T 1J4 Canada</wicri:noCountry></affiliation><affiliation wicri:level="4"><nlm:aff id="Aff2">Faculty of Dentistry, McGill University, 3550 University Street, Montreal, QC H3A 2A7 Canada</nlm:aff><orgName type="university">Université McGill</orgName><country>Canada</country><placeName><settlement type="city">Montréal</settlement><region type="state">Québec</region></placeName></affiliation></author><author><name sortKey="Nguyen, Phan The Huy" sort="Nguyen, Phan The Huy" uniqKey="Nguyen P" first="Phan The Huy" last="Nguyen">Phan The Huy Nguyen</name><affiliation><nlm:aff id="Aff1">Faculty of Dentistry, Université de Montréal, 2900 Edouard-Montpetit, Montreal, QC H3T 1J4 Canada</nlm:aff><wicri:noCountry code="subfield">QC H3T 1J4 Canada</wicri:noCountry></affiliation></author><author><name sortKey="Almeida, Fernanda R" sort="Almeida, Fernanda R" uniqKey="Almeida F" first="Fernanda R" last="Almeida">Fernanda R. Almeida</name><affiliation><nlm:aff id="Aff3">Faculty of Dentistry, University of British Colombia, #103 - 2786W 16th Ave, Vancouver, BC V6K 4M1 Canada</nlm:aff><wicri:noCountry code="subfield">BC V6K 4M1 Canada</wicri:noCountry></affiliation></author><author><name sortKey="Feine, Jocelyne S" sort="Feine, Jocelyne S" uniqKey="Feine J" first="Jocelyne S" last="Feine">Jocelyne S. Feine</name><affiliation wicri:level="4"><nlm:aff id="Aff2">Faculty of Dentistry, McGill University, 3550 University Street, Montreal, QC H3A 2A7 Canada</nlm:aff><orgName type="university">Université McGill</orgName><country>Canada</country><placeName><settlement type="city">Montréal</settlement><region type="state">Québec</region></placeName></affiliation></author><author><name sortKey="Karp, Igor" sort="Karp, Igor" uniqKey="Karp I" first="Igor" last="Karp">Igor Karp</name><affiliation><nlm:aff id="Aff1">Faculty of Dentistry, Université de Montréal, 2900 Edouard-Montpetit, Montreal, QC H3T 1J4 Canada</nlm:aff><wicri:noCountry code="subfield">QC H3T 1J4 Canada</wicri:noCountry></affiliation><affiliation><nlm:aff id="Aff4">Schulich School of Medicine and Dentistry, University of Western Ontario, 1151 Richmond Street, London, ON N6A 5C1 Canada</nlm:aff><wicri:noCountry code="subfield">ON N6A 5C1 Canada</wicri:noCountry></affiliation></author><author><name sortKey="Lavigne, Gilles" sort="Lavigne, Gilles" uniqKey="Lavigne G" first="Gilles" last="Lavigne">Gilles Lavigne</name><affiliation><nlm:aff id="Aff1">Faculty of Dentistry, Université de Montréal, 2900 Edouard-Montpetit, Montreal, QC H3T 1J4 Canada</nlm:aff><wicri:noCountry code="subfield">QC H3T 1J4 Canada</wicri:noCountry></affiliation></author><author><name sortKey="Huynh, Nelly" sort="Huynh, Nelly" uniqKey="Huynh N" first="Nelly" last="Huynh">Nelly Huynh</name><affiliation><nlm:aff id="Aff1">Faculty of Dentistry, Université de Montréal, 2900 Edouard-Montpetit, Montreal, QC H3T 1J4 Canada</nlm:aff><wicri:noCountry code="subfield">QC H3T 1J4 Canada</wicri:noCountry></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">25218696</idno><idno type="pmc">4177759</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4177759</idno><idno type="RBID">PMC:4177759</idno><idno type="doi">10.1186/1745-6215-15-358</idno><date when="2014">2014</date><idno type="wicri:Area/Pmc/Corpus">000084</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000084</idno><idno type="wicri:Area/Pmc/Curation">000084</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">000084</idno><idno type="wicri:Area/Pmc/Checkpoint">000049</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Checkpoint">000049</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">The effect of nocturnal wear of complete dentures on sleep and oral health related quality of life: study protocol for a randomized controlled trial</title><author><name sortKey="Emami, Elham" sort="Emami, Elham" uniqKey="Emami E" first="Elham" last="Emami">Elham Emami</name><affiliation><nlm:aff id="Aff1">Faculty of Dentistry, Université de Montréal, 2900 Edouard-Montpetit, Montreal, QC H3T 1J4 Canada</nlm:aff><wicri:noCountry code="subfield">QC H3T 1J4 Canada</wicri:noCountry></affiliation><affiliation wicri:level="4"><nlm:aff id="Aff2">Faculty of Dentistry, McGill University, 3550 University Street, Montreal, QC H3A 2A7 Canada</nlm:aff><orgName type="university">Université McGill</orgName><country>Canada</country><placeName><settlement type="city">Montréal</settlement><region type="state">Québec</region></placeName></affiliation></author><author><name sortKey="Nguyen, Phan The Huy" sort="Nguyen, Phan The Huy" uniqKey="Nguyen P" first="Phan The Huy" last="Nguyen">Phan The Huy Nguyen</name><affiliation><nlm:aff id="Aff1">Faculty of Dentistry, Université de Montréal, 2900 Edouard-Montpetit, Montreal, QC H3T 1J4 Canada</nlm:aff><wicri:noCountry code="subfield">QC H3T 1J4 Canada</wicri:noCountry></affiliation></author><author><name sortKey="Almeida, Fernanda R" sort="Almeida, Fernanda R" uniqKey="Almeida F" first="Fernanda R" last="Almeida">Fernanda R. Almeida</name><affiliation><nlm:aff id="Aff3">Faculty of Dentistry, University of British Colombia, #103 - 2786W 16th Ave, Vancouver, BC V6K 4M1 Canada</nlm:aff><wicri:noCountry code="subfield">BC V6K 4M1 Canada</wicri:noCountry></affiliation></author><author><name sortKey="Feine, Jocelyne S" sort="Feine, Jocelyne S" uniqKey="Feine J" first="Jocelyne S" last="Feine">Jocelyne S. Feine</name><affiliation wicri:level="4"><nlm:aff id="Aff2">Faculty of Dentistry, McGill University, 3550 University Street, Montreal, QC H3A 2A7 Canada</nlm:aff><orgName type="university">Université McGill</orgName><country>Canada</country><placeName><settlement type="city">Montréal</settlement><region type="state">Québec</region></placeName></affiliation></author><author><name sortKey="Karp, Igor" sort="Karp, Igor" uniqKey="Karp I" first="Igor" last="Karp">Igor Karp</name><affiliation><nlm:aff id="Aff1">Faculty of Dentistry, Université de Montréal, 2900 Edouard-Montpetit, Montreal, QC H3T 1J4 Canada</nlm:aff><wicri:noCountry code="subfield">QC H3T 1J4 Canada</wicri:noCountry></affiliation><affiliation><nlm:aff id="Aff4">Schulich School of Medicine and Dentistry, University of Western Ontario, 1151 Richmond Street, London, ON N6A 5C1 Canada</nlm:aff><wicri:noCountry code="subfield">ON N6A 5C1 Canada</wicri:noCountry></affiliation></author><author><name sortKey="Lavigne, Gilles" sort="Lavigne, Gilles" uniqKey="Lavigne G" first="Gilles" last="Lavigne">Gilles Lavigne</name><affiliation><nlm:aff id="Aff1">Faculty of Dentistry, Université de Montréal, 2900 Edouard-Montpetit, Montreal, QC H3T 1J4 Canada</nlm:aff><wicri:noCountry code="subfield">QC H3T 1J4 Canada</wicri:noCountry></affiliation></author><author><name sortKey="Huynh, Nelly" sort="Huynh, Nelly" uniqKey="Huynh N" first="Nelly" last="Huynh">Nelly Huynh</name><affiliation><nlm:aff id="Aff1">Faculty of Dentistry, Université de Montréal, 2900 Edouard-Montpetit, Montreal, QC H3T 1J4 Canada</nlm:aff><wicri:noCountry code="subfield">QC H3T 1J4 Canada</wicri:noCountry></affiliation></author></analytic><series><title level="j">Trials</title><idno type="eISSN">1745-6215</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>Background</title><p>Edentulism and sleep disturbance are chronic conditions that are common in older people and have serious adverse consequences for their functioning and quality of life. Edentulism can disturb sleep through the alteration of the craniofacial structure and surrounding soft tissue. However, the effect of prosthetic rehabilitation of edentulism on sleep quality is still not well understood. The objectives of this study are to test whether nocturnal denture wear affects sleep quality, daytime sleepiness, and the oral health related quality of life of edentate older people with moderate to severe sleep apnea, and to identify modifiers of effect of nocturnal denture wear.</p></sec><sec><title>Methods/design</title><p>We will carry out a single-blind randomized cross-over trial. Seventy edentate older people with moderate to severe obstructive sleep apnea will be enrolled. The study participants will be assigned to wear and not wear their dentures on alternate periods of 30 days. The outcome measures will be sleep quality (assessed by portable polysomnography), daytime sleepiness (assessed by the Epworth Sleepiness Scale), and oral health related quality of life (assessed by validated questionnaire). A number of characteristics (sociodemographic, oropharyngeal morphology, oral and prosthesis characteristics, and perceived general health quality of life) will be assessed by means of clinical examination, 3D imaging of the craniofacial structure, and validated questionnaires at baseline. Linear mixed effects regression models for repeated measures will be fitted to test the study hypotheses. The main analyses will be based on the intention-to-treat principle. To assess the robustness of the findings to potential incomplete adherence, sensitivity analyses will be conducted while applying the per-protocol principle.</p></sec><sec><title>Discussion</title><p>This practice-relevant evidence could represent a preventive approach to improve sleep characteristics of the older population and improve their well-being and quality of life.</p></sec><sec><title>Trial registration</title><p>ClinicalTrials.gov <ext-link ext-link-type="uri" xlink:href="http://www.clinicaltrials.gov/NCT01868295">NCT01868295</ext-link>.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Canada, H" uniqKey="Canada H">H Canada</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Ancoli Israel, S" uniqKey="Ancoli Israel S">S Ancoli-Israel</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Ancoli Israel, S" uniqKey="Ancoli Israel 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<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">25218696</article-id><article-id pub-id-type="pmc">4177759</article-id><article-id pub-id-type="publisher-id">2235</article-id><article-id pub-id-type="doi">10.1186/1745-6215-15-358</article-id><article-categories><subj-group subj-group-type="heading"><subject>Study Protocol</subject></subj-group></article-categories><title-group><article-title>The effect of nocturnal wear of complete dentures on sleep and oral health related quality of life: study protocol for a randomized controlled trial</article-title></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name><surname>Emami</surname><given-names>Elham</given-names></name><address><email>elham.emami@umontreal.ca</email></address><xref ref-type="aff" rid="Aff1"></xref><xref ref-type="aff" rid="Aff2"></xref></contrib><contrib contrib-type="author"><name><surname>Nguyen</surname><given-names>Phan The Huy</given-names></name><address><email>phan.the.huy.nguyen@umontreal.ca</email></address><xref ref-type="aff" rid="Aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Almeida</surname><given-names>Fernanda R</given-names></name><address><email>falmeida@interchange.ubc.ca</email></address><xref ref-type="aff" rid="Aff3"></xref></contrib><contrib contrib-type="author"><name><surname>Feine</surname><given-names>Jocelyne S</given-names></name><address><email>jocelyne.feine@mcgill.ca</email></address><xref ref-type="aff" rid="Aff2"></xref></contrib><contrib contrib-type="author"><name><surname>Karp</surname><given-names>Igor</given-names></name><address><email>ikarp@uwo.ca</email></address><xref ref-type="aff" rid="Aff1"></xref><xref ref-type="aff" rid="Aff4"></xref></contrib><contrib contrib-type="author"><name><surname>Lavigne</surname><given-names>Gilles</given-names></name><address><email>gilles.lavigne@umontreal.ca</email></address><xref ref-type="aff" rid="Aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Huynh</surname><given-names>Nelly</given-names></name><address><email>nelly.huynh@umontreal.ca</email></address><xref ref-type="aff" rid="Aff1"></xref></contrib><aff id="Aff1"><label></label>Faculty of Dentistry, Université de Montréal, 2900 Edouard-Montpetit, Montreal, QC H3T 1J4 Canada</aff><aff id="Aff2"><label></label>Faculty of Dentistry, McGill University, 3550 University Street, Montreal, QC H3A 2A7 Canada</aff><aff id="Aff3"><label></label>Faculty of Dentistry, University of British Colombia, #103 - 2786W 16th Ave, Vancouver, BC V6K 4M1 Canada</aff><aff id="Aff4"><label></label>Schulich School of Medicine and Dentistry, University of Western Ontario, 1151 Richmond Street, London, ON N6A 5C1 Canada</aff></contrib-group><pub-date pub-type="epub"><day>13</day><month>9</month><year>2014</year></pub-date><pub-date pub-type="pmc-release"><day>13</day><month>9</month><year>2014</year></pub-date><pub-date pub-type="collection"><year>2014</year></pub-date><volume>15</volume><elocation-id>358</elocation-id><history><date date-type="received"><day>25</day><month>7</month><year>2014</year></date><date date-type="accepted"><day>9</day><month>9</month><year>2014</year></date></history><permissions><copyright-statement>© Emami et al.; licensee BioMed Central Ltd. 2014</copyright-statement><license license-type="open-access"><license-p>This article is published under license to BioMed Central Ltd. 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/4.0">http://creativecommons.org/licenses/by/4.0</ext-link>), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. 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>Edentulism and sleep disturbance are chronic conditions that are common in older people and have serious adverse consequences for their functioning and quality of life. Edentulism can disturb sleep through the alteration of the craniofacial structure and surrounding soft tissue. However, the effect of prosthetic rehabilitation of edentulism on sleep quality is still not well understood. The objectives of this study are to test whether nocturnal denture wear affects sleep quality, daytime sleepiness, and the oral health related quality of life of edentate older people with moderate to severe sleep apnea, and to identify modifiers of effect of nocturnal denture wear.</p></sec><sec><title>Methods/design</title><p>We will carry out a single-blind randomized cross-over trial. Seventy edentate older people with moderate to severe obstructive sleep apnea will be enrolled. The study participants will be assigned to wear and not wear their dentures on alternate periods of 30 days. The outcome measures will be sleep quality (assessed by portable polysomnography), daytime sleepiness (assessed by the Epworth Sleepiness Scale), and oral health related quality of life (assessed by validated questionnaire). A number of characteristics (sociodemographic, oropharyngeal morphology, oral and prosthesis characteristics, and perceived general health quality of life) will be assessed by means of clinical examination, 3D imaging of the craniofacial structure, and validated questionnaires at baseline. Linear mixed effects regression models for repeated measures will be fitted to test the study hypotheses. The main analyses will be based on the intention-to-treat principle. To assess the robustness of the findings to potential incomplete adherence, sensitivity analyses will be conducted while applying the per-protocol principle.</p></sec><sec><title>Discussion</title><p>This practice-relevant evidence could represent a preventive approach to improve sleep characteristics of the older population and improve their well-being and quality of life.</p></sec><sec><title>Trial registration</title><p>ClinicalTrials.gov <ext-link ext-link-type="uri" xlink:href="http://www.clinicaltrials.gov/NCT01868295">NCT01868295</ext-link>.</p></sec></abstract><kwd-group xml:lang="en"><title>Keywords</title><kwd>Complete denture</kwd><kwd>edentulism</kwd><kwd>obstructive sleeping apnea</kwd><kwd>oral health related quality of life</kwd><kwd>sleep disorders</kwd><kwd>sleep quality</kwd></kwd-group><custom-meta-group><custom-meta><meta-name>issue-copyright-statement</meta-name><meta-value>© The Author(s) 2014</meta-value></custom-meta></custom-meta-group></article-meta></front></pmc><affiliations><list><country><li>Canada</li></country><region><li>Québec</li></region><settlement><li>Montréal</li></settlement><orgName><li>Université McGill</li></orgName></list><tree><noCountry><name sortKey="Almeida, Fernanda R" sort="Almeida, Fernanda R" uniqKey="Almeida F" first="Fernanda R" last="Almeida">Fernanda R. Almeida</name><name sortKey="Huynh, Nelly" sort="Huynh, Nelly" uniqKey="Huynh N" first="Nelly" last="Huynh">Nelly Huynh</name><name sortKey="Karp, Igor" sort="Karp, Igor" uniqKey="Karp I" first="Igor" last="Karp">Igor Karp</name><name sortKey="Lavigne, Gilles" sort="Lavigne, Gilles" uniqKey="Lavigne G" first="Gilles" last="Lavigne">Gilles Lavigne</name><name sortKey="Nguyen, Phan The Huy" sort="Nguyen, Phan The Huy" uniqKey="Nguyen P" first="Phan The Huy" last="Nguyen">Phan The Huy Nguyen</name></noCountry><country name="Canada"><region name="Québec"><name sortKey="Emami, Elham" sort="Emami, Elham" uniqKey="Emami E" first="Elham" last="Emami">Elham Emami</name></region><name sortKey="Feine, Jocelyne S" sort="Feine, Jocelyne S" uniqKey="Feine J" first="Jocelyne S" last="Feine">Jocelyne S. Feine</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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