Kawai 2005.

Methods	Study design: single‐blinded, parallel‐group RCT Conducted in Montreal General Hospital, Canada Number of centres: 1 Recruitment period and method: between December 2000 and December 2002, large public advertisement, and advertised in retirement homes in province of Québec, Canada Funding source: supported by the Nihon university grant for overseas research and the Suzuki Memorial grant from the Canadian Institutes of Health Research Study duration: follow‐up till May 2003
Participants	Both males and females who were edentulous and aged between 45 and 75 years Inclusion criteria: significant problems with at least one of their existing dentures. Possess an adequate understanding of written and spoken French, and ability to understand and respond to a test questionnaire. Exclusion criteria: symptoms of temporomandibular disorders, xerostomia, orofacial motor disorders, severe oral manifestations of systematic disease, or psychological or psychiatric conditions that could influence response to treatment 128 potential participants recruited after applying inclusion and exclusion criteria, 122 participants included in study and randomised to two groups Group T ‐ 61 randomised; 51 completed study Group S ‐ 61 randomised; 54 completed study
Interventions	Traditional procedure and simplified procedures differed in the following ways: methods of final impression, use of a facebow, type of articulator used, and use of a remount procedure. Two experienced prosthodontists, familiar with both procedures treated participants Intervention group: simplified procedure Single impression: alginate impression materials with stock metal tray. Technique not mentioned Jaw relation: occlusal registration (without facebow transfer) articulated using average value articulator Occlusion: bilateral balanced occlusion Try‐in: done Denture insertion: denture inserted and was adjusted four times every week. Comparator group: traditional procedure Preliminary impression: alginate impression materials with stock metal tray; technique not mentioned Final impression: final impression was taken with a custom tray, border moulded with impression compound, and final impression with polyether rubber impression. Jaw relation: occlusal registration with facebow transfer and semi‐adjustable articulator was used along Occlusion: bilateral balanced occlusion Try‐in: done Denture insertion: remounting procedure done, denture inserted and adjusted until participant and clinician satisfied All lab work carried out by one commercial lab All participants returned for follow‐up visits at 3 and 6 months post denture insertion
Outcomes	Primary outcome: participant rating on a 100‐mm VAS of overall general satisfaction with their set of dentures Secondary outcomes: participant VAS ratings of the maxillary and mandibular dentures alone for satisfaction, comfort, stability, aesthetics, ability to speak, ease of cleaning, and ability to chew soft white bread, hard cheese, raw carrot, sausage, steak, raw apple, and lettuce. Data were gathered at the 3‐ and 6‐month follow‐up visits by a blinded research assistant.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "The randomisation was stratified by clinical condition as a potential confounder according to diagnostic guidelines issued by The American College of Prosthodontists (Class I–Class IV). A blinded research assistant assigned subjects to the groups using computer generated random numbers."
Allocation concealment (selection bias)	Unclear risk	Comment: no adequate information available in article
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "Blinding of the clinicians to treatment allocation was not possible; however, the subjects were not told to which group they were assigned."
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "The clinical assessment of denture quality at the 6‐month recall was carried out by four prosthodontists, who were blinded both to group allocation and to the purpose of the study."
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: there were 15/122 participants lost to follow‐up; however, the number of dropouts was equal in both groups.
Selective reporting (reporting bias)	Low risk	Comment: all outcomes reported as planned
Other bias	Low risk	Comment: no other bias found