Nunez 2015.

Methods	Study design: parallel‐group RCT Conducted in: Federal University of Goias, Brazil Number of centres: 1 Recruitment period: not reported Funding source: supported by a grant from Brazillian National Research Council and State Foundation Research of Goias Study duration: from June 2010 and to April 2012
Participants	Patients from the Brazilian public health system referred for complete dentures at the School of Dentistry of the Federal University of Goias. Inclusion criteria: both males and females, aged between 63 to 65 years, fully edentulous, requiring new upper and lower conventional CD Exclusion criteria: unable to cooperate, or with poor general health, or conditions that could influence response to treatment, such as temporomandibular disorders, orofacial motor disorders, severe oral manifestations of systematic disease, or a psychological or psychiatric condition 50 participants allocated into two groups Traditional group: 25 randomised; 23 completed follow‐up Simplified group: 25 randomised; 22 completed follow‐up
Interventions	The traditional method and simplified method differed in the following ways: methods of impression and use of a facebow. One operator performed all clinical procedures. Intervention group: simplified method Single impression: alginate impression materials with stock metal tray. Technique not mentioned Jaw relation: occlusal registration (without facebow transfer) articulated using average setting on semi‐adjustable articulator Occlusion: bilateral balanced occlusion Try‐in: bilateral balanced articulation check during try‐in Denture insertion: denture inserted and adjustments concluded when the clinician and participants agreed to terminate the visit. Comparator group: traditional method Preliminary impression: alginate impression materials with stock metal tray. Technique not mentioned Final impression: selective‐pressure final impression taken with a custom tray, border moulded with impression compound, and final impression with polysulfide impression Jaw relation: occlusal registration with facebow transfer and articulated using average setting on semi‐adjustable articulator Occlusion: bilateral balanced occlusion Try‐in: bilateral balanced articulation check during try‐in Denture insertion: denture inserted and adjustments concluded when the clinician and the participants agreed to terminate the visit. No remount procedure was done in either group. All lab work was carried out by same dental technician, using standardised procedure for both groups. Participants returned for follow‐up visits at 30 days (1 month) and 6 months post‐insertion.
Outcomes	1. Oral health‐related quality of life (Brazilian OHIP‐EDENT). 4 different scale domains were assessed: (i) masticatory discomfort and disability (4 items), (ii) psychological discomfort and disability (5 items), (iii) social disability (5 items), and (iv) oral pain and discomfort (5 items). 2. Satisfaction of upper and lower denture on a 10‐point VAS 3. General satisfaction with dentures was measured using the participants’ ratings of their overall satisfaction and satisfaction with comfort, stability, aesthetics, ability to speak, and ability to chew. All satisfaction items measured on a 10‐point VAS All treatment outcomes measured before insertion of new denture, at 30 days (1 month) and 6 months post‐insertion
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "All participants who met the inclusion criteria signed an informed consent and were randomly assigned by simple randomisation to two groups." Comment: method of sequence generation not specified
Allocation concealment (selection bias)	Unclear risk	Quote: "All treatments were performed by the same dentist." Comment: not clearly stated in the article. Trial author did not respond to this query.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "All treatments were performed by the same dentist. Blinding of the dentist to group allocation was not possible, though participants were not aware of the treatment protocol to which they were assigned."
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "The outcome assessments were performed by a dentist blinded to the group assignment."
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: only 5 participants lost to follow‐up in both groups
Selective reporting (reporting bias)	Unclear risk	Comment: overall general satisfaction with dentures not reported, but maxillary and mandibular denture satisfaction were reported separately. Trial authors did not respond to this query.
Other bias	Low risk	Comment: no other biases found