UBC Faculty Research and Publications

The effect of nocturnal wear of complete dentures on sleep and oral health related quality of life: study… Emami, Elham; Nguyen, Phan T H; Almeida, Fernanda R; Feine, Jocelyne S; Karp, Igor; Lavigne, Gilles; Huynh, Nelly Sep 13, 2014

Your browser doesn't seem to have a PDF viewer, please download the PDF to view this item.

Item Metadata


52383-13063_2014_Article_2235.pdf [ 406.89kB ]
JSON: 52383-1.0223489.json
JSON-LD: 52383-1.0223489-ld.json
RDF/XML (Pretty): 52383-1.0223489-rdf.xml
RDF/JSON: 52383-1.0223489-rdf.json
Turtle: 52383-1.0223489-turtle.txt
N-Triples: 52383-1.0223489-rdf-ntriples.txt
Original Record: 52383-1.0223489-source.json
Full Text

Full Text

STUDY PROTOCOLThe effect of nocturnal weemedisorders, sleep qualityTRIALSEmami et al. Trials 2014, 15:358http://www.trialsjournal.com/content/15/1/358sion of occlusion can negatively influence sleep and leadQC H3A 2A7, CanadaFull list of author information is available at the end of the articleBackgroundThe worldwide population is rapidly aging, with the ma-jority of older people living longer than previous genera-tions [1]. Aging substantially increases the risk of toothloss and sleep disturbance. In Canada, about one in fourpeople aged 65 and older is completely toothless [2], andnearly half of all older people complain of disturbedsleep [3,4]. These two chronic conditions have seriousadverse consequences for well-being, functioning, andquality of life, and place a significant burden on thehealth care system [5-8]. The costs associated with sleepdisturbance and tooth loss are also substantial [7,9-12].The relationship between edentulism and sleep dis-turbance and sleep-disordered breathing has been welldocumented [13,14]. In fact, anatomical changes associ-ated with edentulism and decrease in the vertical dimen-* Correspondence: elham.emami@umontreal.ca1Faculty of Dentistry, Université de Montréal, 2900 Edouard-Montpetit,Montreal, QC H3T 1J4, Canada2Faculty of Dentistry, McGill University, 3550 University Street, Montreal,and Nelly HuynhAbstractBackground: Edentulism and sleep disturbance are chronic conditions that are common in older people and haveserious adverse consequences for their functioning and quality of life. Edentulism can disturb sleep through thealteration of the craniofacial structure and surrounding soft tissue. However, the effect of prosthetic rehabilitation ofedentulism on sleep quality is still not well understood. The objectives of this study are to test whether nocturnaldenture wear affects sleep quality, daytime sleepiness, and the oral health related quality of life of edentate olderpeople with moderate to severe sleep apnea, and to identify modifiers of effect of nocturnal denture wear.Methods/design: We will carry out a single-blind randomized cross-over trial. Seventy edentate older people withmoderate to severe obstructive sleep apnea will be enrolled. The study participants will be assigned to wear andnot wear their dentures on alternate periods of 30 days. The outcome measures will be sleep quality (assessed byportable polysomnography), daytime sleepiness (assessed by the Epworth Sleepiness Scale), and oral health relatedquality of life (assessed by validated questionnaire). A number of characteristics (sociodemographic, oropharyngealmorphology, oral and prosthesis characteristics, and perceived general health quality of life) will be assessed bymeans 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. Themain analyses will be based on the intention-to-treat principle. To assess the robustness of the findings to potentialincomplete adherence, sensitivity analyses will be conducted while applying the per-protocol principle.Discussion: This practice-relevant evidence could represent a preventive approach to improve sleep characteristics ofthe older population and improve their well-being and quality of life.Trial registration: ClinicalTrials.gov NCT01868295.Keywords: Complete denture, edentulism, obstructive sleeping apnea, oral health related quality of life, sleepon sleep and oral health rstudy protocol for a randoElham Emami1,2*, Phan The Huy Nguyen1, Fernanda R Al1© 2014 Emami et al.; licensee BioMed CentralCommons Attribution License (http://creativecreproduction in any medium, provided the orDedication waiver (http://creativecommons.orunless otherwise stated.Open Accessar of complete dentureslated quality of life:mized controlled trialida3, Jocelyne S Feine2, Igor Karp1,4, Gilles Lavigne1Ltd. This is an Open Access article distributed under the terms of the Creativeommons.org/licenses/by/4.0), which permits unrestricted use, distribution, andiginal work is properly credited. The Creative Commons Public Domaing/publicdomain/zero/1.0/) applies to the data made available in this article,Emami et al. Trials 2014, 15:358 Page 2 of 7http://www.trialsjournal.com/content/15/1/358to obstructive sleep apnea [13-18]. Loss of the verticaldimension of occlusion leads to a forward and upwardmandibular position associated with a backward shift inthe supine position [16,19]. This rotational movement ofthe mandible favors a shift of the tongue and soft palateagainst the posterior pharyngeal wall. The reduction inthe retropharyngeal space associated with impaired func-tion of the upper airway dilatation muscles results inupper airway resistance, and diminished response to nega-tive pressure stimulation [20-22]. Moreover, age-specificcompromised pharyngeal anatomy, upper airway mucosalsensory dysfunction, and a decline in pharyngeal sensorydiscrimination and reflexes have been proposed as beingresponsible for the vulnerability of edentate elders to air-way collapse [23-25]. Furthermore, the literature suggeststhat there is a possible association between sleep disturb-ance and wearing a complete denture during sleep, whichmay explain the mechanism underlying the relationshipbetween obstructive sleep apnea and edentate individuals[26,27]. One hypothesized effect was that the use of a den-ture during sleep may lead to open bite and mouthbreathing with a decrease in the tone of the pharyngealmuscles, thus leading to the development or worsening ofobstructive sleep apnea [28]; an alternative hypothesisholds that sleep quality and pharyngeal patency are main-tained by nocturnal denture use. Moreover, this dentureeffect appears to be different between healthy edentateolder people and those with sleep disturbances [29]. How-ever, there is a general belief amongst oral health care pro-fessionals that edentate individuals should remove theirdentures at night. In fact, numerous studies have demon-strated that long-term nocturnal wearing of dentures canreduce the protective effect of saliva and obstruct goodoxygenation of the oral mucosa, which makes it less resist-ant to mechanical and microbiological aggression, thus in-creasing the risk of chronic inflammatory changes withinthe mucosa [30-32]. This leads to an increased risk oftraumatic ulcers, denture stomatitis, and alveolar bone re-sorption in the edentate population [33-37].However, tooth loss and not wearing dentures at nighthave not been recognized as a risk factor for sleep disturb-ance and obstructive sleep apnea. Furthermore, the limitedquality of studies on this topic (graded as level ≤3 on theOxford level of grade of evidence) [38] do not permit clini-cians to engage in evidence-based clinical decision-making.This lack of knowledge poses legal and ethical problemsfor clinicians and other dental professionals who are in-volved in the care of the growing edentate population.To enable development of clinical practice guidelines,solid evidence is required. Specifically, a rigorous random-ized trial is needed to help determine the effects of den-ture wearing on patient-relevant outcomes [28,39-41].To address this need, we have designed a single-blindrandomized cross-over trial. The first objective of thestudy is to test whether nocturnal denture wear has aneffect on sleep quality and daytime sleepiness of edentateolder people with moderate to severe sleep apnea. Thesecond objective is to test whether nocturnal denturewear has an effect on the oral health related quality oflife of edentate older people with moderate to severesleep apnea. The third objective is to identify modifiersof the putative effects of nocturnal denture wear.Methods/designThe study protocol was approved by the Research EthicsBoard of Health of the Université de Montréal (Project13-076-CERES-D). The trial is registered in the USClinical Trials Registry NCT01868295.Recruitment processParticipants will be recruited from the area of metropol-itan Montreal. Participants will be recruited through theresearch, prosthodontics, and sleep apnea clinics of theUniversité de Montréal, associated hospitals, geriatric in-stitutes, and private sleep clinics.The research coordinator will contact the patients inperson at the clinics with a study information brochureto invite them to participate in the trial. Potential studyparticipants will be asked to contact a research coordin-ator via a dedicated phone number with voicemail. Theresearch coordinator will describe the study in generalterms and assess major inclusion criteria, and the studycandidates will be invited to an in-person informationand screening session. During this session, the researchcoordinator will inform these potential participants ofthe general health risks associated with obstructive sleepapnea and will explain all aspects of the study, using aPowerPoint presentation and a study brochure. The in-terested participants will be screened for eligibility forinclusion in the study. Eligible participants will be askedto read and sign a consent form. Informed consent willbe obtained from each eligible participant before pro-ceeding with the trial.Inclusion and exclusion criteriaInclusion criteriaTo be considered for inclusion in the study, the subjectmust: (1) be aged 65 years or older; (2) have worn acomplete set of removable dentures in the past year butnot have worn the dentures during sleep in that period;(3) have an Apnea-Hypopnea Index (AHI) score of atleast 15 at screening; (4) have an adequate understand-ing of written and spoken English or French; (5) be ableto understand and respond to the questionnaires used inthe study; (6) agree to follow the research study instruc-tions; (7) agree to adhere to the allocated sequence of in-terventions; (8) consume no alcohol and (9) not worklate at night on the day before polysomnography.Exclusion criteriaThe participants are excluded if they: (1) have an AHI scoreless than 15; (2) have any severe cardiologic, neurologic, psy-chological, or psychiatric condition, respiratory disease, acuteairway infection, or any other health condition that jeopar-dizes sleep; (3) score 24 or less on the Mini-Mental StateEvaluation [42]; (4) regularly consume more than two (forwomen) or three (for men) alcoholic beverages per day; (5)are taking medication or any illicit drug that will affect sleeparchitecture or respiratory muscle activity (that is, hypnotics,psychostimulants, anticonvulsant, or antipsychotics); (6) arereceiving regular continuous positive airway pressure therapyor nocturnal supplemental oxygen; (7) have sleepinessdeemed to be unsafe and requiring urgent treatment; or (8)feel that the trial would negatively influence their private life.Intervention, randomization, allocation concealment, andsequence generationA single-blind randomized cross-over clinical trial willbe conducted. The trial will have two sequences and twoperiods (balanced design).Eligible study participants will be randomly assignedto wear or not wear their complete dentures at night, al-ternately, for two periods of 30 days (Figure 1). Minimalor no carry-over effect is expected based on the actionof the postulated mechanism of intervention [28] (add-itional analyses of raw data from research team memberFRA: Grizzle’s model [43] sequence effect P = 0.8, periodeffect P = 0.9, intervention effect P = 0.002). Therefore,no wash-out period was deemed necessary.To achieve a balanced allocation of participants in eachsequence, a permuted block randomization with varyingblock sizes using SAS® PROC PLAN will be used [44-51].Randomization and administration of opaque sequentialenvelopes will be carried out off-site. The sleep technolo-gist will deliver these envelopes to study participants attheir homes. Each participant will receive a sequentiallynumbered, sealed, opaque, tamper-proof envelope indicat-ing the sequence of intervention, and intervention willstart on the same day (one week after baseline assess-ment). All the investigators, the research coordinator,and the scoring service providers will be blinded to theRecruitmentizBaseline data collectionpe paScreening Emami et al. Trials 2014, 15:358 Page 3 of 7http://www.trialsjournal.com/content/15/1/358RandomSleeping with denturesFirst Second(30 dSleeping with denturesOutcome assessment (T1)Outcome assessment (T2)Figure 1 Trial design.ationSleeping without denturesriod eriod ys) Sleeping without denturesOutcome assessment (T1)Outcome assessment (T2)istration of study questionnaires, and cone-beam com-hypopneic incidents per hour of sleep [56]. The AHIEmami et al. Trials 2014, 15:358 Page 4 of 7http://www.trialsjournal.com/content/15/1/358index will be measured using diagnostic portable poly-somnography units for overnight home use [57]. Stand-ard polysomnography measurements will include totalsleep duration, sleep efficiency, sleep onset latency, electro-encephalogram arousal index, spontaneous arousals, andsleep-stage distribution. Upon return of the device, poly-somnographic data will be downloaded and scored usingREMLogic software (Embla Inc., Canada) to assess AHI,snoring index, respiratory disturbance index, flow limita-tion, respiratory efforts related arousals, and average andminimal oxygen saturation. These respiratory events willputed tomography (CBCT) (NewTom 5G CBCT, QR S.r.l.-Verona, Italy), as described. Then, in the same week,they will undergo one baseline portable overnight re-cording (level II polysomnography) [52]. Follow-up datawill be collected at the end of each period by the sleeptechnologist at home by means of one portable overnightrecording and the outcome questionnaires. The sleep tech-nologist will install the device at the participants’ homes onthe evening of recording, verifying electrode impedanceand signal quality. This approach will allow us to maximizethe participation of older people and will increase their ad-herence to the study procedures [53].Primary outcome measuresThe selection of the outcomes was based on a literaturereview and consultation with experts in sleep and oralhealth disease [54,55].The primary outcome is a change in sleep quality, asmeasured by the AHI index. This index is a marker ofsleep quality that represents the number of apneic andintervention assignment. Data will be gathered, measured,recorded, and entered in a blinded fashion. Blinding willbe lifted once data analysis is complete. Although it is notpossible for the participants to be ‘blind’ to the interven-tion, they will be asked not to discuss their interventionswith any research staff. Any question from participantsduring the intervention period will be answered by two in-dependent prosthodontists and, if necessary, a sleep clin-ician, as these individuals will not be involved in datacollection or data analyses.Data collectionPersons who consent to participate in the study will beinvited to visit the clinical research laboratories of theFaculty of Dental Medicine at the Université de Mon-tréal at their convenience. During this visit, one trainedand calibrated research trainee will conduct baselinedata collection, including a clinical examination, admin-be scored by Sleep Strategies Inc. (Canada), according toAmerican Academy of Sleep Medicine guidelines [58].Secondary outcome measuresSecondary outcomes will be changes in daytime sleepi-ness and oral health related quality of life.The Epworth Sleepiness Scale (ESS) will be used to as-sess perceived daytime sleepiness. The ESS is an eight-item, four-point scale (0 to 3) with strong internalconsistency (Cronbach’s α = 0.81) and half-split reliability(r = 0.82) [59]. Participants will be asked to rate theirchance of dozing in eight different sedentary situations.Scores of 10 or more suggest excessive daytime sleepiness.Oral health related quality of life will be measured bymeans of the Oral Health Impact Profile (OHIP-20) [60].This instrument is a disease-specific measure of people’sperceptions of the impact of denture wear on physical,psychological, and social aspects of their quality of life.This validated and highly reliable (α = 0.88) oral healthdisease-specific instrument has been widely used in geri-atric dental research [61-63] and has been tested andvalidated in English- and French-speaking Canadians forcross-cultural validity. The range of the scale is 20 to120 points, with lower scores indicating a better oralhealth related quality of life [60,64].The primary and secondary outcome measures will bedetermined at baseline and at the end of each 30-dayperiod.CovariatesWe will also collect data on sociodemographic, medical,and anthropometric (weight, height) characteristics, oro-pharyngeal morphology (measured by a three-dimensionalimaging system, CBCT), as well as edentulism-associatedcharacteristics (vertical dimension of occlusion accordingto prosthodontic standard criteria, history of tooth loss,history of denture use, and nocturnal denture wear) [65]and general health. Perceived general health will beassessed using the Short Form-36 (SF-36) [66]. This isa generic self-administered questionnaire consisting ofeight multi-item subscales: physical functioning, socialfunctioning, role limitations due to physical health prob-lems, and role limitations due to emotional problems,mental health, vitality, pain, and general health percep-tions. The SF-36 has excellent internal consistency anddiscriminates between individuals with and withoutchronic disease [66-68]. The computerized scoring sys-tem will be used according to the user’s manual, inwhich higher scores represent a better condition [69].Sample size justificationAssuming that (i) the minimal clinically important dif-ference in the AHI score between the two interventionsis 5 events per hour (based on the opinion of expert cli-nicians, Delphi method) [70], (ii) the standard deviationof the distribution of the difference in AHI score be-tween interventions is 10.6 events per hour (based onEmami et al. Trials 2014, 15:358 Page 5 of 7http://www.trialsjournal.com/content/15/1/358estimates from our pilot data) [28], and (iii) the drop-outrate is 10% (based on our pilot data), a sample size of 70study participants will ensure a 0.90 power to reject the nullhypothesis if it is indeed false, at a two-sided Bonferroni-adjusted α level of 0.0167 (to account for the three studyoutcomes).The sample size of 70 would ensure a power of morethan 0.90 to detect a difference of 2.5 units in the meanESS score (assuming that the standard deviation is 3.5units) [71], and a difference of 17 units (minimal clinic-ally important difference) [72] in the mean OHIP score(assuming that the standard deviation is 23.8 units) [73], ata two-sided Bonferroni-adjusted α level of 0.0167 [74,75].Statistical analysisDescriptive analyses for all variables will be performed.In case of apparent material deviations from normality,the distributions of the dependent variables will be nor-malized by appropriate transformations.Mixed linear models will be fitted using SAS ProcMixed (SAS version 9.3, SAS Institute Inc., USA) to testthe associations between the intervention and each ofthe study outcomes [76]. The model will include vari-ables for intervention, randomization sequence, period,and baseline value of the study outcome as fixed effectsand subject as a random effect. Hypotheses concerningmodel parameters will be tested by Wald tests with anapproximate F null distribution.To test for potential modification of the impact of theintervention by determining the presence of sleep dis-turbance at baseline, and the degree of sleep disturbanceat baseline, we will introduce a series of interactionterms between the intervention status and each of thesecharacteristics (one at a time) into the above-describedlinear models.All of the analyses will be carried out in accordance withthe intention-to-treat principle, and various strategies willbe contemplated, to account for post-randomization miss-ing data in the case of non-balanced missing data or attri-tion of more than 10% of participants. However, in thesensitivity analyses, we will also carry out per-protocolanalyses to assess the robustness of our findings to poten-tial incomplete adherence: in particular, patients withmajor protocol violations or poor adhere will be excluded.DiscussionThis research could inform planning for a preventiveapproach to improve sleep characteristics of the olderpopulation and, thereby, improve well-being and qualityof life. The evidence produced by this trial will assist inproducing truly evidence-based practice guidelines usedby primary care providers, dentists, and sleep medicinespecialists, who provide care for the millions of edentateolder people around the world [56].Trial statusThe project is currently in the recruitment phase.AbbreviationsAHI: Apnea-Hypopnea Index; CBCT: cone-beam computed tomography;ESS: Epworth Sleepiness Scale questionnaire; OHIP-20: Oral Health ImpactProfile questionnaire; SF-36: Short Form-36 Health Survey questionnaire.Competing interestsThe authors declare that they have no competing interests.Authors’ contributionsEE, NH, and PTHN drafted the manuscript. EE, NH, and GL participated in theconception, design and coordination of the study. FRA, JSF, and IK helpedrevised the manuscript and participated in the conception and design of thestudy. All the authors revised and approved the final manuscript forpublication.AcknowledgementsThe trial is funded by Canadian Institutes of Health Research (grant number:325899) and is supported by the facilities of Université de Montréal, Quebec,Canada. The authors would also like to acknowledge the study collaboratorsand knowledge users: Matthieu Schmittbuhl, Frédéric Series, Julie Carrier,Louis de Koninck, and Pierre de Grandmont. The authors are grateful for thewilling participation of study participants.Author details1Faculty of Dentistry, Université de Montréal, 2900 Edouard-Montpetit,Montreal, QC H3T 1J4, Canada. 2Faculty of Dentistry, McGill University,3550 University Street, Montreal, QC H3A 2A7, Canada. 3Faculty of Dentistry,University of British Colombia, #103 - 2786W 16th Ave, Vancouver, BC V6K 4M1,Canada. 4Schulich School of Medicine and Dentistry, University of WesternOntario, 1151 Richmond Street, London, ON N6A 5C1, Canada.Received: 25 July 2014 Accepted: 9 September 2014Published: 13 September 2014References1. Department of Economic and Social Affairs - Population Division: WorldPopulation to 2300. New York: United Nations Publication; 2004.2. Health Canada Report of the Findings of the Oral Health Component of theCanadian Health Measures Survey 2007-2009. Ottawa, ON: Ministry of Health;2010.3. Ancoli-Israel S: Sleep and its disorders in aging populations. Sleep Med2009, 10(Suppl 1):S7–S11.4. Ancoli-Israel S, Ayalon L, Salzman C: Sleep in the elderly: normal variationsand common sleep disorders. Harv Rev Psychiatr 2008, 16:279–286.5. Jean-Louis G, Kripke DF, Ancoli-Israel S: Sleep and quality of well-being.Sleep 2000, 23:1115–1121.6. Zeitlhofer J, Schmeiser-Rieder A, Tribl G, Rosenberger A, Bolitschek J, Kapfhammer G,Saletu B, Katschnig H, Holzinger B, Popovic R, Kunze M: Sleep and quality of lifein the Austrian population. Acta Neurol Scand 2000, 102:249–257.7. Hossain JL, Shapiro CM: The prevalence, cost implications, and managementof sleep disorders: an overview. Sleep Breath Schlaf Atm 2002, 6:85–102.8. Rakel RE: Clinical and societal consequences of obstructive sleep apneaand excessive daytime sleepiness. Postgrad Med 2009, 121:86–95.9. Hillman DR, Murphy AS, Pezzullo L: The economic cost of sleep disorders.Sleep 2006, 29:299–305.10. Kapur KK, Garrett NR, Hamada MO, Roumanas ED, Freymiller E, Han T,Diener RM, Levin S, Wong WK: Randomized clinical trial comparing theefficacy of mandibular implant-supported overdentures and conventionaldentures in diabetic patients. Part III: comparisons of patient satisfaction.J Prosthet Dent 1999, 82:416–427.11. Vernazza C, Heasman P, Gaunt F, Pennington M: How to measure thecost-effectiveness of periodontal treatments. Periodontol 2000 2012,60:138–146.12. The Canadian Centre for Policy Alternatives: Putting Our Money Where OurMouth Is: The Future of Dental Care in Canada. Ottawa, ON: 2011. http://www.policyalternatives.ca/sites/default/files/uploads/publications/National%20Office/2011/04/Putting%20our%20money%20where%20our%20mouth%20is.pdfEmami et al. Trials 2014, 15:358 Page 6 of 7http://www.trialsjournal.com/content/15/1/35813. Bucca C, Carossa S, Pivetti S, Gai V, Rolla G, Preti G: Edentulism andworsening of obstructive sleep apnoea. Lancet 1999, 353:121–122.14. Bucca C, Cicolin A, Brussino L, Arienti A, Graziano A, Erovigni F, Pera P, Gai V,Mutani R, Preti G, Rolla G, Carossa S: Tooth loss and obstructive sleepapnoea. Respir Res 2006, 7:8.15. Erovigni F, Graziano A, Ceruti P, Gassino G, De Lillo A, Carossa S:Cephalometric evaluation of the upper airway in patients with completedentures. Minerva Stomatol 2005, 54:293–301.16. Gassino G, Cicolin A, Erovigni F, Carossa S, Preti G: Obstructive sleep apnea,depression, and oral status in elderly occupants of residential homes.Int J Prosthodont 2005, 18:316–322.17. Gupta P, Thombare R, Pakhan AJ, Singhal S: Cephalometric evaluation ofthe effect of complete dentures on retropharyngeal space and its effecton spirometric values in altered vertical dimension. ISRN Dent 2011,2011:516969.18. Huynh N, Emami E, Helman J, Chervin R: Interactions between sleepdisorders and oral diseases. Oral Dis 2014, 20:236–245.19. Endeshaw YW, Katz S, Ouslander JG, Bliwise DL: Association of denture usewith sleep-disordered breathing among older adults. J Public Health Dent2004, 64:181–183.20. Ivanhoe JR, Cibirka RM, Lefebvre CA, Parr GR: Dental considerations inupper airway sleep disorders: a review of the literature. J Prosthet Dent1999, 82:685–698.21. Kurtulmus H, Cotert HS: Management of obstructive sleep apnea with amandibular and tongue advancement splint (MTAS) in a completelyedentulous patient. A clinical report. J Prosthodont Off J Am CollProsthodont 2009, 18:348–352.22. Nayar S, Knox J: Management of obstructive sleep apnea in anedentulous patient with a mandibular advancement splint: a clinicalreport. J Prosthet Dent 2005, 94:108–111.23. Ancoli-Israel S, Kripke DF: Prevalent sleep problems in the aged.Biofeedback Self Regul 1991, 16:349–359.24. Wolkove N, Elkholy O, Baltzan M, Palayew M: Sleep and aging: 1. Sleepdisorders commonly found in older people. CMAJ 2007, 176:1299–1304.25. Nguyen ATD, Jobin V, Payne R, Beauregard J, Naor N, Kimoff RJ: Laryngealand velopharyngeal sensory impairment in obstructive sleep apnea.Sleep 2005, 28:585–593.26. Hung H-C, Colditz G, Joshipura KJ: The association between tooth lossand the self-reported intake of selected CVD-related nutrients and foodsamong US women. Community Dent Oral Epidemiol 2005, 33:167–173.27. Österberg T, Dey DK, Sundh V, Carlsson GE, Jansson J-O, Mellström D:Edentulism associated with obesity: a study of four national surveysof 16 416 Swedes aged 55-84 years. Acta Odontol Scand 2010, 68:360–367.28. Almeida FR, Furuyama RJ, Chaccur DC, Lowe AA, Chen H, Bittencourt LR,Frigeiro MLMA, Tsuda H: Complete denture wear during sleep in elderlysleep apnea patients - a preliminary study. Sleep Breath 2012, 16:855–863.29. Emami E, Lavigne G, de Grandmont P, Rompré PH, Feine JS: Perceivedsleep quality among edentulous elders. Gerodontology 2012, 29:e128–e134.30. Cumming CG, Wight C, Blackwell CL, Wray D: Denture stomatitis in theelderly. Oral Microbiol Immunol 1990, 5:82–85.31. Emami E, Séguin J, Rompré PH, de Koninck L, de Grandmont P, Barbeau J:The relationship of myceliated colonies of Candida albicans with denturestomatitis: an in vivo/in vitro study. Int J Prosthodont 2007, 20:514–520.32. Felton D, Cooper L, Duqum I, Minsley G, Guckes A, Haug S, Meredith P,Solie C, Avery D, Deal Chandler N, American College of Prosthodontists:Evidence-based guidelines for the care and maintenance of completedentures: a publication of the American College of Prosthodontists.J Prosthodont 2011, 20(Suppl 1):S1–S12.33. Sumi Y, Miura H, Michiwaki Y, Nagaosa S, Nagaya M: Colonization of dentalplaque by respiratory pathogens in dependent elderly. Arch GerontolGeriatr 2007, 44:119–124.34. Marcus PA, Joshi A, Jones JA, Morgano SM: Complete edentulism anddenture use for elders in New England. J Prosthet Dent 1996, 76:260–266.35. Emami E, de Grandmont P, Rompré PH, Barbeau J, Pan S, Feine JS: Favoringtrauma as an etiological factor in denture stomatitis. J Dent Res 2008,87:440–444.36. Divaris K, Ntounis A, Marinis A, Polyzois G, Polychronopoulou A: Loss ofnatural dentition: multi-level effects among a geriatric population.Gerodontology 2012, 29:e192–e199.37. Zomorodian K, Haghighi NN, Rajaee N, Pakshir K, Tarazooie B, Vojdani M,Sedaghat F, Vosoghi M: Assessment of Candida species colonization anddenture-related stomatitis in complete denture wearers. Med Mycol 2011,49:208–211.38. ORBi: OCEBM Levels of Evidence Working Group - Oxford Centre forEvidence‐Based Medicine 2011 Levels of Evidence ‐ Traduction française.In [http://orbi.ulg.ac.be/handle/2268/113937]39. Arisaka H, Sakuraba S, Tamaki K, Watanabe T, Takeda J, Yoshida K: Effects ofwearing complete dentures during sleep on the Apnea-Hypopnea Index.Int J Prosthodont 2009, 22:173–177.40. Grimshaw J, Freemantle N, Wallace S, Russell I, Hurwitz B, Watt I, Long A,Sheldon T: Developing and implementing clinical practice guidelines.Qual Health Care 1995, 4:55–64.41. Sibbald B, Roland M: Understanding controlled trials: why are randomisedcontrolled trials important? BMJ 1998, 316:201.42. Folstein MF, Folstein SE, McHugh PR: ‘Mini-Mental State’. A practicalmethod for grading the cognitive state of patients for the clinician. J PsychiatrRes 1975, 12:189–198.43. Grizzle JE: The two-period change-over design and its use in clinical trials.Biometrics 1965, 21:467–480.44. Anisimov VV: Effects of unstratified and centre-stratified randomization inmulti-centre clinical trials. Pharm Stat 2011, 10:50–59.45. Kundt G, Glass A: Evaluation of imbalance in stratified blockedrandomization: some remarks on the range of validity of the model byHallstrom and Davis. Methods Inf Med 2012, 51:55–62.46. Kundt G: Comparative evaluation of balancing properties of stratifiedrandomization procedures. Methods Inf Med 2009, 48:129–134.47. Lachin JM: Statistical properties of randomization in clinical trials.Control Clin Trials 1988, 9:289–311.48. Ma Z, Hu F: Balancing continuous covariates based on Kernel densities.Contemp Clin Trials 2013, 34:262–269.49. Matts JP, Lachin JM: Properties of permuted-block randomization in clinicaltrials. Control Clin Trials 1988, 9:327–344.50. Signorini DF, Leung O, Simes RJ, Beller E, Gebski VJ, Callaghan T: Dynamicbalanced randomization for clinical trials. Stat Med 1993, 12:2343–2350.51. Zhang Y, Rosenberger WF, Smythe RT: Sequential monitoring ofrandomization tests: stratified randomization. Biometrics 2007, 63:865–872.52. Corral-Peñafiel J, Pepin J-L, Barbe F: Ambulatory monitoring in the diagnosisand management of obstructive sleep apnoea syndrome. Eur Respir Rev OffJ Eur Respir Soc 2013, 22:312–324.53. Carra MC, Huynh NT, El-Khatib H, Remise C, Lavigne GJ: Sleep bruxism,snoring, and headaches in adolescents: short-term effects of a mandibularadvancement appliance. Sleep Med 2013, 14:656–661.54. American Academy of Sleep Medicine Task Force: Sleep-relatedbreathing disorders in adults: recommendations for syndromedefinition and measurement techniques in clinical research. TheReport of an American Academy of Sleep Medicine Task Force.Sleep 1999, 22:667–689.55. Bloom HG, Ahmed I, Alessi CA, Ancoli-Israel S, Buysse DJ, Kryger MH, PhillipsBA, Thorpy MJ, Vitiello MV, Zee PC: Evidence-based recommendations forthe assessment and management of sleep disorders in older persons.J Am Geriatr Soc 2009, 57:761–789.56. American Academy of Sleep Medicine: The International Classification ofSleep Disorders, Revised - Diagnotic and Coding Manual. 2001. http://www.esst.org/adds/ICSD.pdf57. Tiihonen P, Hukkanen T, Tuomilehto H, Mervaala E, Töyräs J: Evaluation of anovel ambulatory device for screening of sleep apnea. Telemed E-Health2009, 15:283–289.58. American Academy of Sleep Medicine: The AASM Manual for theScoring of Sleep and Associated Events. In [http://www.aasmnet.org/scoringmanual/default.aspx]59. Johns MW: A new method for measuring daytime sleepiness: theEpworth Sleepiness Scale. Sleep 1991, 14:540–545.60. Slade AJSGD: Development and evaluation of the Oral Health ImpactProfile. Community Dent Health 1994, 11:3–11.61. Slade GD: Assessing change in quality of life using the Oral HealthImpact Profile. Community Dent Oral Epidemiol 1998, 26:52–61.62. Locker D, Slade G: Oral health and the quality of life among olderadults: the oral health impact profile. J Can Dent Assoc 1993, 59:830–833.837–838, 844.63. Heydecke G, Locker D, Awad MA, Lund JP, Feine JS: Oral and generalhealth-related quality of life with conventional and implant dentures.Community Dent Oral Epidemiol 2003, 31:161–168.64. Emami E, de Grandmont P, Rompré P: Oral health quality of life andphysical health. Int J Health 2011, 1:157–170.65. Nuckton TJ, Glidden DV, Browner WS, Claman DM: Physical examination:Mallampati score as an independent predictor of obstructive sleepapnea. Sleep 2006, 29:903–908.66. Ware JE: SF-36 Physical and Mental Health Summary Scales: A User’s Manual.The Health Institute, New England Medical Center; 1994. http://www.google.ca/search?hl=vi&tbo=p&tbm=bks&q=inauthor:%22Mark+Kosinski%22&source=gbs_metadata_r&cad=667. Hopman WM, Towheed T, Anastassiades T, Tenenhouse A, Poliquin S,Berger C, Joseph L, Brown JP, Murray TM, Adachi JD, Hanley DA,Papadimitropoulos E: Canadian normative data for the SF-36 health survey.Canadian Multicentre Osteoporosis Study Research Group. CMAJ 2000,163:265–271.68. Ware JE, Sherbourne CD: The MOS 36-item short-form health survey (SF-36).I. Conceptual framework and item selection. Med Care 1992, 30:473–483.69. Ware JE, Snow KK, Kosinski M, Gandek B, Institute NEMCHH: SF-36 HealthSurvey: Manual and Interpretation Guide. Boston, MA: The Health Institute,New England Medical Center; 1993.70. Sumsion T: The Delphi technique: an adaptive research tool. Br J OccupThere 1998, 61:153–156.71. Emami E, Beauchamp A, Rompré P: Sleep stability in edentate eldersSubmit your next manuscript to BioMed Centraland take full advantage of: • Convenient online submission• Thorough peer review• No space constraints or color figure charges• Immediate publication on acceptance• Inclusion in PubMed, CAS, Scopus and Google Scholar• Research which is freely available for redistributionEmami et al. Trials 2014, 15:358 Page 7 of 7http://www.trialsjournal.com/content/15/1/358[abstract]. J Dent Res 2012 2012, 91(Special Issue B):163999.72. Emami E, Heydecke G, Rompré PH, de Grandmont P, Feine JS: Impact ofimplant support for mandibular dentures on satisfaction, oral andgeneral health-related quality of life: a meta-analysis of randomized-controlledtrials. Clin Oral Implants Res 2009, 20:533–544.73. Michaud P-L, de Grandmont P, Feine JS, Emami E: Measuring patient-basedoutcomes: is treatment satisfaction associated with oral health-relatedquality of life? J Dent 2012, 40:624–631.74. Leon AC, Marzuk PM, Portera L: More reliable outcome measures canreduce sample size requirements. Arch Gen Psychiatry 1995, 52:867–871.75. Sherrill JT, Sommers DI, Nierenberg AA, Leon AC, Arndt S, Bandeen-Roche K,Greenhouse J, Guthrie D, Normand S-L, Phillips KA, Shear MK, Woolson R:Integrating statistical and clinical research elements in intervention-relatedgrant applications: summary from an NIMH workshop. Acad Psychiatry2009, 33:221–228.76. Putt M, Chinchilli VM: A mixed effects model for the analysis of repeatedmeasures cross-over studies. Stat Med 1999, 18:3037–3058.doi:10.1186/1745-6215-15-358Cite this article as: Emami et al.: The effect of nocturnal wear of completedentures on sleep and oral health related quality of life: study protocol fora randomized controlled trial. Trials 2014 15:358.Submit your manuscript at www.biomedcentral.com/submit


Citation Scheme:


Citations by CSL (citeproc-js)

Usage Statistics



Customize your widget with the following options, then copy and paste the code below into the HTML of your page to embed this item in your website.
                            <div id="ubcOpenCollectionsWidgetDisplay">
                            <script id="ubcOpenCollectionsWidget"
                            async >
IIIF logo Our image viewer uses the IIIF 2.0 standard. To load this item in other compatible viewers, use this url:


Related Items