Randomized Study For Minimally Invasive Splinted Implants
Not Applicable
Completed
- Conditions
- Jaw, Edentulous
- Registration Number
- NCT02107612
- Lead Sponsor
- University of Concepcion, Chile
- Brief Summary
The purpose of this study was to evaluate the effect of a integrated system for inserting two splinted minimally-invasive implants, to retain mandibular over dentures, on the quality of life of edentulous patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
Inclusion Criteria
- Edentulous
- Men and women
- Between 45 and 90 years of age
- Who had a persistent loss of stability and retention of their conventional mandibular dentures
- Without temporomandibular disorders
Exclusion Criteria
- Uncontrolled systemic disease (eg, hypertension, diabetes)
- Severe osteoporosis (bone mineral density > 2.5 SD below the young adult reference mean, plus 1 or more fragility fractures) and/or taking bisphosphonates
- Mental disorders
- Who had received radiotherapy in the 18 months prior to the trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in Quality of Life One year Quality of life was assessed using the Oral Health Impact Profile (OHIP) for assessing health-related quality of life in edentulous adults (EDENT) scale with 19 items.
- Secondary Outcome Measures
Name Time Method Incidence of complications Two years Complications: infection, implant failure, presence of signs and symptoms of peri-implant mucositis.
Trial Locations
- Locations (1)
University of Concepción
🇨🇱Concepción, Región del Bio Bio, Chile
University of Concepción🇨🇱Concepción, Región del Bio Bio, Chile