| Methods |
Study design: parallel‐group RCT
Conducted in University of California, USA
Number of centres: not stated
Recruitment period: not stated
Funding source: not stated
Study duration: not stated |
| Participants |
30 edentulous participants who had worn dentures previously were randomly assigned into two groups of 15 |
| Interventions |
Preliminary impression was made with irreversible hydrocolloid in stock metal tray for 30 participants
Group 1 ‐ final‐impression wax used. 15 randomised; 13 completed study
Group 2 ‐ light body polysulfide impression. 15 randomised; 14 completed study
Dentures were inserted and adjustments were recorded over one year. |
| Outcomes |
Dentures inserted were evaluated for stability, patient comfort, health of oral tissues, and need for denture adjustments, checked after 24 hours, one week, six months, and one year. |
| Notes |
Only one‐year denture adjustment results were reported; other outcomes were not reported in the study. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Quote: "Fifteen patients were randomly selected for final impression materials either a light‐body polysulfide rubber or wax."
Comment: method of randomisation not stated in the article |
| Allocation concealment (selection bias) |
Unclear risk |
Comment: not stated in the article |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Comment: not stated in the article, but blinding of personnel not possible |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Comment: not stated in the article |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Comment: three participants in the wax final‐impression group and one participant in the polysulfide group were lost to follow‐up after one year; this was not stated clearly in the text of the article. |
| Selective reporting (reporting bias) |
High risk |
Quote: "Complete dentures made from these impressions were checked after 24 h, one week, six months, and one year to determine denture stability, patient comfort, health of oral tissues, and need for denture adjustments."
Comment: only denture adjustments were reported for one year as planned. |
| Other bias |
Low risk |
Comment: no other bias found |
