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. 2018 Apr 4;2018(4):CD012256. doi: 10.1002/14651858.CD012256.pub2

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