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Open Access Study protocol

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

Janine C Gray1, Nuria Navarro-Coy1, Sue H Pavitt2, Claire Hulme3, Mary Godfrey4, Helen L Craddock5, Paul A Brunton5, Sarah Brown1, Sean Dillon5, Gillian Dukanovic5, Catherine Fernandez17, Jonathan Wright1, Howard Collier1, Shirley Swithenbank6, Carol Lee6 and T Paul Hyde5*

Author Affiliations

1 Clinical Trials Research Unit, University of Leeds, Leeds, LS2 9JT, UK

2 Centre for Health Sciences Research, Leeds Institute of Health Sciences, University of Leeds, Charles Thackrah, 101 Clarendon Road, Leeds, LS2 9LJ, UK

3 Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Charles Thackrah, 101 Clarendon Road, Leeds, LS2 9LJ, UK

4 Centre for Health and Social Care, Leeds Institute of Health Sciences, University of Leeds, Charles Thackrah, 101 Clarendon Rd., Leeds, LS2 9LJ, UK

5 Leeds Dental Institute, Clarendon Road, University of Leeds, Leeds, LS2 9LU, UK

6 IMPROVDENT PPI representatives, c/o Leeds Dental Institute, Clarendon Road, University of Leeds, Leeds, LS2 9LU, UK

7 Dental Translational and Clinical Research Unit (DenTCRU), Leeds Dental Institute, Clarendon Road, University of Leeds, Leeds, LS2 9LU, UK

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BMC Oral Health 2012, 12:37  doi:10.1186/1472-6831-12-37

Published: 31 August 2012

Abstract

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

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