NCT02339194.
Trial name or title | Application of a simplified method of complete denture fabrication for severely resorbed mandibular ridges |
Methods |
Study design: single‐blinded, Phase 3 parallel RCT Conducted in University Federal do Ceara, Brazil Number of centres: 1 Recruitment period: not stated Funding source: University Federal do Ceara Study duration: 18 months |
Participants | Participant estimate: 72 Inclusion criteria: (1) severely resorbed mandibular alveolar bones; (2) complete edentulism for at least one year; (3) desire to receive a pair of new conventional complete dentures; (4) mental receptiveness; (5) good understanding of spoken Portuguese; (6) both males and females 45 years and older Exclusion criteria: (1) disorders of the masticatory system; (2) pathological changes of residual ridges; (3) debilitating systemic diseases |
Interventions | Procedure: denture fabrication technique Group A: experimental ‐ simplified protocol ‐ denture fabrication technique (single impression with alginate through prefabricated trays for both arches) Group B: no intervention – traditional protocol (only mandibular secondary impression made with border moulding using compound and impression rubber in custom tray) |
Outcomes | Primary outcomes: oral health‐related quality of life (time frame 6 months) assessed using Brazilian version of Oral Health Impact Profile for edentulous patients inventory Secondary outcomes: (1) satisfaction with dentures assessed by means of two specific questionnaires (time frame 6 months); (2) denture quality by clinical examination (time frame 3 months); (3) masticatory performance assessed by colorimetric method (time frame 6 months) |
Starting date | January 2014 |
Contact information | Samara M Sales DDS, samarah_sales@hotmail.com, 8596523217 |
Notes | Recruiting participants |