Improvdent: Improving dentures for patient benefit. A crossover randomised clinical trial comparing impression materials for complete dentures

BMC Oral Health

T Paul Hyde²  Carol Lee⁶  Shirley Swithenbank⁶  Howard Collier⁷  Jonathan Wright⁷  Catherine Fernandez⁴  Gillian Dukanovic²  Sean Dillon²  Sarah Brown⁷  Paul A Brunton²  Helen L Craddock²  Mary Godfrey⁵  Claire Hulme³  Sue H Pavitt¹  Nuria Navarro-Coy⁷  Janine C Gray⁷ 

[1] Centre for Health Sciences Research, Leeds Institute of Health Sciences, University of Leeds, Charles Thackrah, 101 Clarendon Road, Leeds, LS2 9LJ, UK;Leeds Dental Institute, Clarendon Road, University of Leeds, Leeds, LS2 9LU, UK;Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Charles Thackrah, 101 Clarendon Road, Leeds, LS2 9LJ, UK;Dental Translational and Clinical Research Unit (DenTCRU), Leeds Dental Institute, Clarendon Road, University of Leeds, Leeds, LS2 9LU, UK;Centre for Health and Social Care, Leeds Institute of Health Sciences, University of Leeds, Charles Thackrah, 101 Clarendon Rd., Leeds, LS2 9LJ, UK;IMPROVDENT PPI representatives, c/o Leeds Dental Institute, Clarendon Road, University of Leeds, Leeds, LS2 9LU, UK;Clinical Trials Research Unit, University of Leeds, Leeds, LS2 9JT, UK

关键词: Crossover trial;    Cost-effectiveness;    Impression material;    Edentulous;    Complete dentures;   

Others  :  1126371
DOI  :  10.1186/1472-6831-12-37

 received in 2012-06-01, accepted in 2012-07-06,  发布年份 2012

【 摘 要 】

Background

According to the UK Adult Dental Health Survey (2009) 15% of adults aged 65–74, 30% aged 75–84 and 47% aged >85 years are edentulous and require complete dentures. Patients’ quality of life and nutrition status are affected by poor dentures. The quality of the dental impression is the most important issue for improving the fit and comfort of new dentures. There is paucity of RCT evidence for which impression material is best for complete dentures construction. This study aims to compare two impression materials for effectiveness and cost effectiveness.

Methods/Design

IMPROVDENT is a double-blind crossover trial comparing the use of alginate and silicone, two commonly used denture impression materials, in terms of patient preference and cost-effectiveness. Eighty five edentulous patients will be recruited and provided with two sets of dentures, similar in all aspects except for the impression material used (alginate or silicone). Patients will try both sets of dentures for a two-week period, unadjusted, to become accustomed to the feel of the new dentures (habituation period). Patients will then wear each set of dentures for a period of 8 weeks (in random order) during which time the dentures will be adjusted for optimum comfort. Finally, patients will be given both sets of dentures for a further two weeks to wear whichever denture they prefer (confirmation period).

Patients will be asked about quality of life and to rate dentures on function and comfort at the end of each trial period and asked which set they prefer at the end of the habituation period (unadjusted denture preference) and confirmation period (adjusted denture preference). A health economic evaluation will estimate incremental cost-effectiveness ratios of producing dentures from the two materials. A qualitative study will investigate the impact of dentures on behaviour and quality of life.

Funding: IMPROVDENT is funded by NIHR RfPB (PB-PG-0408-16300).

Discussion

This trial aims to provide evidence on the costs and quality of dentures cast from two different commonly used impression materials; the intention is to significantly impact on the quality of denture production within NHS dentistry.

Trial Registration

ISRCTN Register: ISRCTN01528038

UKCRN Portfolio ID: 8305

【 授权许可】

   
2012 Gray et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Fuller E, Steele J, Watt R, Nuttall N: In 1: Oral health and function – a report from the Adult Dental Health Survey. Edited by Ian O’ S, Deborah L. 2009. http://www.ic.nhs.uk/statistics-and-data-collections/primary-care/dentistry/adult-dental-health-survey-2009--summary-report-and-thematic-series webcite
• [2]Jagger R, Barker E, Dhaliwal N, Allen F: Assessment of the oral health related quality of life of patients awaiting initial prosthetic assessment. Eur J Prosthodont Restor Dent 2006, 14:111-115.
• [3]Heydecke G, Tedesco LA, Kowalski C, Inglehart MR: Complete dentures and oral health-related quality of life – do coping styles matter? Community Dent Oral Epidemiol 2004, 32:297-306.
• [4]John MT, Szentpétery A, Steele JG: Association between factors related to the time of wearing complete dentures and oral health-related quality of life in patients who maintained a recall. Int J Prosthodont 2007, 20:31-36.
• [5]Adam RZ, Geerts GA, Lalloo R: The impact of new complete dentures on oral health related quality of life. SADJ 2007, 62:264-266. 268
• [6]Ellis JS, Pelekis ND, Thomason JM: Conventional rehabilitation of edentulous patients: the impact on oral health-related quality of life and patient satisfaction. J Prosthodont 2007, 16:37-42.
• [7]Ellis JS, Thomason JM, Jepson NJ, Nohl F, Smith DG, Allen PF: A randomized controlled trial of food choices made by edentulous adults. Clin. Oral Impl. Res 2008, 19:356-361.
• [8]Harwood CL: The evidence base for current practices in prosthodontics. Eur J Prosthodont Restor Dent 2008, 16:24-34.
• [9]McCord JF, McNally LM, Smith PW, Grey NJ: Does the nature of the definitive impression material influence the outcome of (mandibular) complete dentures? Eur J Prosthodont Restor Dent 2005, 13:105-108.
• [10]Hochman N, Yaniv O: Comparative clinical evaluation of removable partial dentures made from impressions with different materials. Compend Contin Educ Dent 1998, 19:200-202. 204–6
• [11]Hyde TP, McCord JF: Survey of prosthodontic impression procedures for complete dentures in general dental practice in the United Kingdom. J Pros Dent 1999, 81:295-299.
• [12]Petrie CS, Walker MP, Williams K: A Survey of U.S. Prosthodontists and Dental Schools on the Current Materials and Methods for Final Impressions for Complete Denture Prosthodontics. J Prosthodont 2005, 14:253-262.
• [13]Tang L, Lund JP, Tache R, Clokie CM, Feine JS: A within subject comparison of mandibular long-bar and hybrid implant supported prostheses: sychometric evaluation and patient preference. J Dent Res 1997, 76:1675-1683.
• [14]Awad MA, Feine JS: Measuring patient satisfaction with mandibular prostheses. Community Dent Oral Epidemiol 1998, 26:400-405.
• [15]Awad MA, Lund JP, Shapiro SH, Locker D, Klemetti E, Chehade A, et al.: Oral health status and treatment satisfaction with mandibular implant overdentures and conventional dentures: a randomized clinical trial in a senior population. Int J Prosthodont 2003, 16:390-396.
• [16]Dillon S, Hyde TP, Brunton PA: A Technique to Construct Duplicate Dentures for Clinical Research. Quin J Dent Tech 2008, 6:30-39.
• [17]Basker RM, Davenport JC: Prosthetic Treatment of the Edentulous Patient. 4th edition. Oxford: Blackwell; 2002:165.
• [18]Allen F, Locker D: A modified short version of the oral health impact profile for assessing health-related quality of life in edentulous adults. Int J Prosthodont 2002, 15:446-450.
• [19]Brooks RG, Jendteg S, Lindgren B, Persson U, Björk S: EuroQol: health related quality of life measurement. Results of Swedish questionnaire exercise. Health Policy 1991, 18(1):37-48.
• [20]Kind P, Dolan P: The effect of past and present illness experience on the valuations of health states. Med Care 1995, 33(4 suppl):AS255-AS263.
• [21]Charmaz K: Constructing grounded theory: a practical guide through qualitative analysis. London: Sage Publications; 2006.
• [22]Jokstad A, Esposito M, Coulthard P, Worthington HV: The reporting of randomized controlled trials in prosthodontics. Int J Prosthodont 2002, 15(3):230-242.
• [23]Sutton AF, Worthington HV, McCord JF: RCT comparing posterior occlusal forms for complete dentures. J Dent Res 2007, 86(7):651-655.
• [24]Hyde TP, Craddock HL, Blance A, Brunton PA: A cross-over Randomised Controlled Trial of selective pressure impressions for lower complete dentures. J Dent 2010, 38(11):853-858. Epub 2010, Jul 15