title: A randomised controlled trial of complete denture impression materials.
abstract: OBJECTIVE
  There is continuing demand for non-implant prosthodontic treatment and yet there is a paucity of high quality Randomised Controlled Trial (RCT) evidence for best practice. The aim of this research was to provide evidence for best practice in prosthodontic impressions by comparing two impression materials in a double-blind, randomised, crossover, controlled, clinical trial.
  
  
  METHODS
  Eighty-five patients were recruited, using published eligibility criteria, to the trial at Leeds Dental Institute, UK. Each patient received two sets of dentures; made using either alginate or silicone impressions. Randomisations determined the order of assessment and order of impressions. The primary outcome was patient blinded preference for unadjusted dentures. Secondary outcomes were patient preference for the adjusted dentures, rating of comfort, stability and chewing efficiency, experience of each impression, and an OHIP-EDENT questionnaire.
  
  
  RESULTS
  Seventy-eight (91.8%) patients completed the primary assessment. 53(67.9%) patients preferred dentures made from silicone impressions while 14(17.9%) preferred alginate impressions. 4(5.1%) patients found both dentures equally satisfactory and 7 (9.0%) found both equally unsatisfactory. There was a 50% difference in preference rates (in favour of silicone) (95%CI 32.7-67.3%, p<0.0001).
  
  
  CONCLUSIONS
  There is significant evidence that dentures made from silicone impressions were preferred by patients.
  
  
  CONCLUSIONS
  Given the strength of the clinical findings within this paper, dentists should consider choosing silicone rather than alginate as their material of choice for secondary impressions for complete dentures.
  
  
  BACKGROUND
  ISRCTN 01528038. This article forms part of a project for which the author (TPH) won the Senior Clinical Unilever Hatton Award of the International Assocation for Dental Research, Capetown, South Africa, June 2014.
authors.affiliation: Leeds Dental Institute, University of Leeds, Leeds LS2 9LU, UK. Electronic address: t.p.hyde@leeds.ac.uk.
authors.forename: T P
authors.initials: TP
authors.lastname: Hyde
authors.affiliation: University of Aberdeen Dental School, Cornhill Road, Aberdeen AB25 2ZR, UK.
authors.forename: H L
authors.initials: HL
authors.lastname: Craddock
authors.affiliation: Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds LS2 9JT, UK.
authors.forename: J C
authors.initials: JC
authors.lastname: Gray
authors.affiliation: Applied Health Research, Leeds Institute of Health Sciences, University of Leeds, Leeds LS2 9LJ, UK.
authors.forename: S H
authors.initials: SH
authors.lastname: Pavitt
authors.affiliation: Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds LS2 9LJ, UK.
authors.forename: C
authors.initials: C
authors.lastname: Hulme
authors.affiliation: Health and Social Care, Leeds Institute of Health Sciences, Leeds LS2 9LJ, UK.
authors.forename: M
authors.initials: M
authors.lastname: Godfrey
authors.affiliation: Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds LS2 9JT, UK.
authors.forename: C
authors.initials: C
authors.lastname: Fernandez
authors.affiliation: Leeds Institute of Clinical Trials Research, University of Leeds, Leeds LS2 9JT, UK.
authors.forename: N
authors.initials: N
authors.lastname: Navarro-Coy
authors.affiliation: Leeds Dental Institute, University of Leeds, Leeds LS2 9LU, UK.
authors.forename: S
authors.initials: S
authors.lastname: Dillon
authors.affiliation: Leeds Institute of Clinical Trials Research, University of Leeds, Leeds LS2 9JT, UK.
authors.forename: J
authors.initials: J
authors.lastname: Wright
authors.affiliation: Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds LS2 9JT, UK.
authors.forename: S
authors.initials: S
authors.lastname: Brown
authors.affiliation: Dental Translational Clinical Research Unit (DenTCRU), Leeds Dental institute, University of Leeds, Leeds LS2 9LU, UK.
authors.forename: G
authors.initials: G
authors.lastname: Dukanovic
authors.affiliation: Leeds Dental Institute, University of Leeds, Leeds LS2 9LU, UK; Faculty of Dentistry, University of Otago, Dunedin, New Zealand.
authors.forename: P A
authors.initials: PA
authors.lastname: Brunton
mesh_terms: D000222:Adaptation, Physiological / Q000502:physiology; D000368:Aged; D000464:Alginates / Q000737:chemistry; D018592:Cross-Over Studies; D003760:Dental Impression Materials / Q000737:chemistry*; D003761:Dental Impression Technique; D003779:Denture Design; D003781:Denture Retention; D003824:Denture, Complete; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D020723:Glucuronic Acid / Q000737:chemistry; D006603:Hexuronic Acids / Q000737:chemistry; D006801:Humans; D008297:Male; D008409:Mastication / Q000502:physiology; D008875:Middle Aged; D009909:Oral Health; D057240:Patient Preference; D017060:Patient Satisfaction; D011788:Quality of Life; D012826:Silicone Elastomers / Q000737:chemistry
chemical_list: D000464:Alginates; D003760:Dental Impression Materials; C102652:Extrude; D006603:Hexuronic Acids; D012826:Silicone Elastomers; D020723:Glucuronic Acid
keywords: Edentulous; Impression materials; Patient outcomes; Prosthodontics; Quality-of life; Removable prosthodontics