Regis 2013.
| Methods | Study design: parallel‐arm RCT Conducted in Ribeirao Preto Dental School, Brazil Number of centres: 1 Recruitment period: October 2010 to April 2011 Funding source: funded by FAPESP Study duration: not mentioned | |
| Participants | Participants, both male and female, aged over 45 years and edentulous for at least 1 year, requesting treatment with upper and lower complete dentures, were recruited through referral by the Brazilian public health system to the Ribeirao Preto Dental School. Inclusion criteria: mental receptiveness, good understanding of spoken Portuguese, and provision of informed consent Exclusion criteria: compromised masticatory system disorders, pathological changes of residual ridges, and debilitating systemic diseases 72 assessed, 42 randomised, 39 completed study S group ‐ 21 participants, 19 completed study at 6 month follow‐up C group ‐ 21 participants, 20 completed study at 6 month follow‐up |
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| Interventions | The traditional method and conventional method of CD fabrication differed in the following ways: methods of impression and use of a facebow and single try‐in appointment for one group. Intervention group: simplified method Single impression: irreversible hydrocolloid impression materials with stock metal tray. Technique not mentioned Jaw relation: registration of maxillomandibular relationship (without facebow transfer) articulated using 15‐degree flat plane indicator on semi‐adjustable articulator Try‐in: done Denture insertion: denture inserted and adjustments done at 1st, 7th, and 14th day; further appointment if required, until no participants presented with discomfort or mucosal irritation Comparator group: traditional method Preliminary impression: alginate impression materials with stock metal tray. Technique not mentioned Final impression: taken with a custom tray, border moulded with impression compound and final impression with zinc‐oxide eugenol impression paste Jaw relation: maxillomandibular registration with facebow transfer and articulated using average setting on semi‐adjustable articulator of 30‐degree horizontal condylar inclination, and 15‐degree lateral condylar inclination Occlusion: anatomic teeth with 33 bilateral balanced occlusion Anterior try‐in: anterior teeth done separately Posterior try‐in: posterior teeth try‐in Denture insertion: denture inserted and adjustments done at 1st, 7th, and 14th day; further appointment if required, until no participants presented with discomfort or mucosal irritation No remount procedure done in either group All lab work carried out by same dental technician under the supervision of the operating clinician |
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| Outcomes | Outcomes evaluated at baseline, 3 months and 6 months for: 1. Patient‐reported OHRQoL using OHIP‐EDENT questionnaire 2. Patient‐reported satisfaction of the denture 3. Operator‐assessed quality of the denture | |
| Notes | Single study published as three publications for different outcomes | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Participants were randomly divided into two groups and received new dentures fabricated according to a simplified (Group S) or a conventional method (Group C – comparator). Allocation to group was performed according to a sequence of computer‐generated random numbers." |
| Allocation concealment (selection bias) | Low risk | Quote: "A researcher (R2) uninvolved with other trial procedure prepared and secured the codes, which were concealed by means of numbered, opaque, and sealed envelopes. For each participant, an envelope was opened after the first appointment, following the obtainment of an initial set of casts." |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: one publication of the study states that blinding was done whenever applicable Comment: it was not possible to blind personnel |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "A blinded researcher (P3) applied both instruments before treatment (baseline) and at the 3‐ and 6‐month follow‐up appointments." |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: 39 participants completed the study. Only 3 participants lost to follow‐up, so it is unlikely the loss to follow‐up influenced the outcomes |
| Selective reporting (reporting bias) | Low risk | Comment: all outcomes stated in methods section were reported in results section |
| Other bias | Low risk | No other biases found |