The effect of nocturnal wear of complete dentures on sleep and oral health related quality of life: study protocol for a randomized controlled trial

Elham Emami, Phan The Huy Nguyen, Fernanda R Almeida, Jocelyne S Feine, Igor Karp, Gilles Lavigne, Nelly Huynh, Elham Emami, Phan The Huy Nguyen, Fernanda R Almeida, Jocelyne S Feine, Igor Karp, Gilles Lavigne, Nelly Huynh

Abstract

Background: 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.

Methods/design: 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.

Discussion: 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.

Trial registration: ClinicalTrials.gov NCT01868295.

Figures

Figure 1
Figure 1
Trial design.

References

    1. Department of Economic and Social Affairs - Population Division . World Population to 2300. New York: United Nations Publication; 2004.
    1. Canada H. Report of the Findings of the Oral Health Component of the Canadian Health Measures Survey 2007-2009. Ottawa, ON: Ministry of Health; 2010.
    1. Ancoli-Israel S. Sleep and its disorders in aging populations. Sleep Med. 2009;10(Suppl 1):S7–S11. doi: 10.1016/j.sleep.2009.07.004.
    1. Ancoli-Israel S, Ayalon L, Salzman C. Sleep in the elderly: normal variations and common sleep disorders. Harv Rev Psychiatr. 2008;16:279–286. doi: 10.1080/10673220802432210.
    1. Jean-Louis G, Kripke DF, Ancoli-Israel S. Sleep and quality of well-being. Sleep. 2000;23:1115–1121.
    1. 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 life in the Austrian population. Acta Neurol Scand. 2000;102:249–257. doi: 10.1034/j.1600-0404.2000.102004249.x.
    1. Hossain JL, Shapiro CM. The prevalence, cost implications, and management of sleep disorders: an overview. Sleep Breath Schlaf Atm. 2002;6:85–102. doi: 10.1055/s-2002-32322.
    1. Rakel RE. Clinical and societal consequences of obstructive sleep apnea and excessive daytime sleepiness. Postgrad Med. 2009;121:86–95. doi: 10.3810/pgm.2009.01.1957.
    1. Hillman DR, Murphy AS, Pezzullo L. The economic cost of sleep disorders. Sleep. 2006;29:299–305.
    1. Kapur KK, Garrett NR, Hamada MO, Roumanas ED, Freymiller E, Han T, Diener RM, Levin S, Wong WK. Randomized clinical trial comparing the efficacy of mandibular implant-supported overdentures and conventional dentures in diabetic patients. Part III: comparisons of patient satisfaction. J Prosthet Dent. 1999;82:416–427. doi: 10.1016/S0022-3913(99)70028-4.
    1. Vernazza C, Heasman P, Gaunt F, Pennington M. How to measure the cost-effectiveness of periodontal treatments. Periodontol 2000. 2012;60:138–146. doi: 10.1111/j.1600-0757.2011.00406.x.
    1. The Canadian Centre for Policy Alternatives . Putting Our Money Where Our Mouth Is: The Future of Dental Care in Canada. ON: Ottawa; 2011.
    1. Bucca C, Carossa S, Pivetti S, Gai V, Rolla G, Preti G. Edentulism and worsening of obstructive sleep apnoea. Lancet. 1999;353:121–122. doi: 10.1016/S0140-6736(05)76158-4.
    1. 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 sleep apnoea. Respir Res. 2006;7:8. doi: 10.1186/1465-9921-7-8.
    1. Erovigni F, Graziano A, Ceruti P, Gassino G, De Lillo A, Carossa S. Cephalometric evaluation of the upper airway in patients with complete dentures. Minerva Stomatol. 2005;54:293–301.
    1. 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.
    1. Gupta P, Thombare R, Pakhan AJ, Singhal S. Cephalometric evaluation of the effect of complete dentures on retropharyngeal space and its effect on spirometric values in altered vertical dimension. ISRN Dent. 2011;2011:516969.
    1. Huynh N, Emami E, Helman J, Chervin R. Interactions between sleep disorders and oral diseases. Oral Dis. 2014;20:236–245. doi: 10.1111/odi.12152.
    1. Endeshaw YW, Katz S, Ouslander JG, Bliwise DL. Association of denture use with sleep-disordered breathing among older adults. J Public Health Dent. 2004;64:181–183. doi: 10.1111/j.1752-7325.2004.tb02749.x.
    1. Ivanhoe JR, Cibirka RM, Lefebvre CA, Parr GR. Dental considerations in upper airway sleep disorders: a review of the literature. J Prosthet Dent. 1999;82:685–698. doi: 10.1016/S0022-3913(99)70010-7.
    1. Kurtulmus H, Cotert HS. Management of obstructive sleep apnea with a mandibular and tongue advancement splint (MTAS) in a completely edentulous patient. A clinical report. J Prosthodont Off J Am Coll Prosthodont. 2009;18:348–352. doi: 10.1111/j.1532-849X.2008.00432.x.
    1. Nayar S, Knox J. Management of obstructive sleep apnea in an edentulous patient with a mandibular advancement splint: a clinical report. J Prosthet Dent. 2005;94:108–111. doi: 10.1016/j.prosdent.2005.05.006.
    1. Ancoli-Israel S, Kripke DF. Prevalent sleep problems in the aged. Biofeedback Self Regul. 1991;16:349–359. doi: 10.1007/BF00999989.
    1. Wolkove N, Elkholy O, Baltzan M, Palayew M. Sleep and aging: 1. Sleep disorders commonly found in older people. CMAJ. 2007;176:1299–1304. doi: 10.1503/cmaj.060792.
    1. Nguyen ATD, Jobin V, Payne R, Beauregard J, Naor N, Kimoff RJ. Laryngeal and velopharyngeal sensory impairment in obstructive sleep apnea. Sleep. 2005;28:585–593.
    1. Hung H-C, Colditz G, Joshipura KJ. The association between tooth loss and the self-reported intake of selected CVD-related nutrients and foods among US women. Community Dent Oral Epidemiol. 2005;33:167–173. doi: 10.1111/j.1600-0528.2005.00200.x.
    1. Österberg T, Dey DK, Sundh V, Carlsson GE, Jansson J-O, Mellström D. Edentulism associated with obesity: a study of four national surveys of 16 416 Swedes aged 55-84 years. Acta Odontol Scand. 2010;68:360–367. doi: 10.3109/00016357.2010.514721.
    1. Almeida FR, Furuyama RJ, Chaccur DC, Lowe AA, Chen H, Bittencourt LR, Frigeiro MLMA, Tsuda H. Complete denture wear during sleep in elderly sleep apnea patients - a preliminary study. Sleep Breath. 2012;16:855–863. doi: 10.1007/s11325-011-0587-9.
    1. Emami E, Lavigne G, de Grandmont P, Rompré PH, Feine JS. Perceived sleep quality among edentulous elders. Gerodontology. 2012;29:e128–e134. doi: 10.1111/j.1741-2358.2010.00426.x.
    1. Cumming CG, Wight C, Blackwell CL, Wray D. Denture stomatitis in the elderly. Oral Microbiol Immunol. 1990;5:82–85. doi: 10.1111/j.1399-302X.1990.tb00232.x.
    1. Emami E, Séguin J, Rompré PH, de Koninck L, de Grandmont P, Barbeau J. The relationship of myceliated colonies of Candida albicans with denture stomatitis: an in vivo/in vitro study. Int J Prosthodont. 2007;20:514–520.
    1. 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 complete dentures: a publication of the American College of Prosthodontists. J Prosthodont. 2011;20(Suppl 1):S1–S12.
    1. Sumi Y, Miura H, Michiwaki Y, Nagaosa S, Nagaya M. Colonization of dental plaque by respiratory pathogens in dependent elderly. Arch Gerontol Geriatr. 2007;44:119–124. doi: 10.1016/j.archger.2006.04.004.
    1. Marcus PA, Joshi A, Jones JA, Morgano SM. Complete edentulism and denture use for elders in New England. J Prosthet Dent. 1996;76:260–266. doi: 10.1016/S0022-3913(96)90169-9.
    1. Emami E, de Grandmont P, Rompré PH, Barbeau J, Pan S, Feine JS. Favoring trauma as an etiological factor in denture stomatitis. J Dent Res. 2008;87:440–444. doi: 10.1177/154405910808700505.
    1. Divaris K, Ntounis A, Marinis A, Polyzois G, Polychronopoulou A. Loss of natural dentition: multi-level effects among a geriatric population. Gerodontology. 2012;29:e192–e199. doi: 10.1111/j.1741-2358.2010.00440.x.
    1. Zomorodian K, Haghighi NN, Rajaee N, Pakshir K, Tarazooie B, Vojdani M, Sedaghat F, Vosoghi M. Assessment of Candida species colonization and denture-related stomatitis in complete denture wearers. Med Mycol. 2011;49:208–211. doi: 10.3109/13693786.2010.507605.
    1. ORBi: OCEBM Levels of Evidence Working Group - Oxford Centre for Evidence‒Based Medicine 2011 Levels of Evidence ‒ Traduction française []
    1. Arisaka H, Sakuraba S, Tamaki K, Watanabe T, Takeda J, Yoshida K. Effects of wearing complete dentures during sleep on the Apnea-Hypopnea Index. Int J Prosthodont. 2009;22:173–177.
    1. 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. doi: 10.1136/qshc.4.1.55.
    1. Sibbald B, Roland M. Understanding controlled trials: why are randomised controlled trials important? BMJ. 1998;316:201. doi: 10.1136/bmj.316.7126.201.
    1. Folstein MF, Folstein SE, McHugh PR. ‘Mini-Mental State’. A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975;12:189–198. doi: 10.1016/0022-3956(75)90026-6.
    1. Grizzle JE. The two-period change-over design and its use in clinical trials. Biometrics. 1965;21:467–480. doi: 10.2307/2528104.
    1. Anisimov VV. Effects of unstratified and centre-stratified randomization in multi-centre clinical trials. Pharm Stat. 2011;10:50–59. doi: 10.1002/pst.412.
    1. Kundt G, Glass A. Evaluation of imbalance in stratified blocked randomization: some remarks on the range of validity of the model by Hallstrom and Davis. Methods Inf Med. 2012;51:55–62. doi: 10.3414/ME10-01-0078.
    1. Kundt G. Comparative evaluation of balancing properties of stratified randomization procedures. Methods Inf Med. 2009;48:129–134.
    1. Lachin JM. Statistical properties of randomization in clinical trials. Control Clin Trials. 1988;9:289–311. doi: 10.1016/0197-2456(88)90045-1.
    1. Ma Z, Hu F. Balancing continuous covariates based on Kernel densities. Contemp Clin Trials. 2013;34:262–269. doi: 10.1016/j.cct.2012.12.004.
    1. Matts JP, Lachin JM. Properties of permuted-block randomization in clinical trials. Control Clin Trials. 1988;9:327–344. doi: 10.1016/0197-2456(88)90047-5.
    1. Signorini DF, Leung O, Simes RJ, Beller E, Gebski VJ, Callaghan T. Dynamic balanced randomization for clinical trials. Stat Med. 1993;12:2343–2350. doi: 10.1002/sim.4780122410.
    1. Zhang Y, Rosenberger WF, Smythe RT. Sequential monitoring of randomization tests: stratified randomization. Biometrics. 2007;63:865–872. doi: 10.1111/j.1541-0420.2006.00735.x.
    1. Corral-Peñafiel J, Pepin J-L, Barbe F. Ambulatory monitoring in the diagnosis and management of obstructive sleep apnoea syndrome. Eur Respir Rev Off J Eur Respir Soc. 2013;22:312–324. doi: 10.1183/09059180.00004213.
    1. Carra MC, Huynh NT, El-Khatib H, Remise C, Lavigne GJ. Sleep bruxism, snoring, and headaches in adolescents: short-term effects of a mandibular advancement appliance. Sleep Med. 2013;14:656–661. doi: 10.1016/j.sleep.2013.03.009.
    1. American Academy of Sleep Medicine Task Force Sleep-related breathing disorders in adults: recommendations for syndrome definition and measurement techniques in clinical research. The Report of an American Academy of Sleep Medicine Task Force. Sleep. 1999;22:667–689.
    1. Bloom HG, Ahmed I, Alessi CA, Ancoli-Israel S, Buysse DJ, Kryger MH, Phillips BA, Thorpy MJ, Vitiello MV, Zee PC. Evidence-based recommendations for the assessment and management of sleep disorders in older persons. J Am Geriatr Soc. 2009;57:761–789. doi: 10.1111/j.1532-5415.2009.02220.x.
    1. American Academy of Sleep Medicine . The International Classification of Sleep Disorders, Revised - Diagnotic and Coding Manual. 2001.
    1. Tiihonen P, Hukkanen T, Tuomilehto H, Mervaala E, Töyräs J. Evaluation of a novel ambulatory device for screening of sleep apnea. Telemed E-Health. 2009;15:283–289. doi: 10.1089/tmj.2008.0118.
    1. American Academy of Sleep Medicine: The AASM Manual for the Scoring of Sleep and Associated Events. []
    1. Johns MW. A new method for measuring daytime sleepiness: the Epworth Sleepiness Scale. Sleep. 1991;14:540–545.
    1. Slade AJSGD. Development and evaluation of the Oral Health Impact Profile. Community Dent Health. 1994;11:3–11.
    1. Slade GD. Assessing change in quality of life using the Oral Health Impact Profile. Community Dent Oral Epidemiol. 1998;26:52–61. doi: 10.1111/j.1600-0528.1998.tb02084.x.
    1. Locker D, Slade G. Oral health and the quality of life among older adults: the oral health impact profile. J Can Dent Assoc. 1993;59:830–833.
    1. Heydecke G, Locker D, Awad MA, Lund JP, Feine JS. Oral and general health-related quality of life with conventional and implant dentures. Community Dent Oral Epidemiol. 2003;31:161–168. doi: 10.1034/j.1600-0528.2003.00029.x.
    1. Emami E, de Grandmont P, Rompré P. Oral health quality of life and physical health. Int J Health. 2011;1:157–170.
    1. Nuckton TJ, Glidden DV, Browner WS, Claman DM. Physical examination: Mallampati score as an independent predictor of obstructive sleep apnea. Sleep. 2006;29:903–908.
    1. Ware JE. SF-36 Physical and Mental Health Summary Scales: A User’s Manual. New England Medical Center: The Health Institute; 1994.
    1. 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.
    1. 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. doi: 10.1097/00005650-199206000-00002.
    1. Ware JE, Snow KK, Kosinski M, Gandek B, Institute NEMCHH . SF-36 Health Survey: Manual and Interpretation Guide. Boston, MA: The Health Institute, New England Medical Center; 1993.
    1. Sumsion T. The Delphi technique: an adaptive research tool. Br J Occup There. 1998;61:153–156.
    1. Emami E, Beauchamp A, Rompré P. Sleep stability in edentate elders [abstract] J Dent Res 2012. 2012;91(Special Issue B):163999.
    1. Emami E, Heydecke G, Rompré PH, de Grandmont P, Feine JS. Impact of implant support for mandibular dentures on satisfaction, oral and general health-related quality of life: a meta-analysis of randomized-controlled trials. Clin Oral Implants Res. 2009;20:533–544.
    1. Michaud P-L, de Grandmont P, Feine JS, Emami E. Measuring patient-based outcomes: is treatment satisfaction associated with oral health-related quality of life? J Dent. 2012;40:624–631. doi: 10.1016/j.jdent.2012.04.007.
    1. Leon AC, Marzuk PM, Portera L. More reliable outcome measures can reduce sample size requirements. Arch Gen Psychiatry. 1995;52:867–871. doi: 10.1001/archpsyc.1995.03950220077014.
    1. 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-related grant applications: summary from an NIMH workshop. Acad Psychiatry. 2009;33:221–228. doi: 10.1176/appi.ap.33.3.221.
    1. Putt M, Chinchilli VM. A mixed effects model for the analysis of repeated measures cross-over studies. Stat Med. 1999;18:3037–3058. doi: 10.1002/(SICI)1097-0258(19991130)18:22<3037::AID-SIM243>;2-7.

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