Mandibular Implants in Elderly Patients
- Conditions
- Edentulous Complete Denture Wearers
- Interventions
- Procedure: Conventional relineDevice: Implant placement
- Registration Number
- NCT01928004
- Lead Sponsor
- University of Geneva, Switzerland
- Brief Summary
The purpose of this study is to investigate denture satisfaction following the conversion of existing mandibular complete dentures to implant-overdentures (IOD) in very old edentulous patients who depend on help for activities of daily living (ADL) and evaluate secondary endpoints such as functional, structural, nutritional, cognitive and patient-centered outcome measures.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
- 75 years or older
- living institutionalized or receiving help for the ADL
- edentulous
- wearing complete dentures
- the lower denture had to cause discomfort to the degree that the patients were seeking treatment
- severe clinical depression
- dementia
- poorly controlled diabetes
- immunosuppression
- treatment with bisphosphonates
- condition precluding the surgical intervention for implant placement
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description denture reline Conventional reline conventional reline of mandibular complete denture implant placement Implant placement insertion of 2 interforaminal mandibular implants and conversion of the lower complete denture to an implant-overdenture
- Primary Outcome Measures
Name Time Method Change from Baseline in Denture satisfaction at 3, 12, 24 and 36 months VAS-scale score to evaluate the subjective satisfaction with the denture
- Secondary Outcome Measures
Name Time Method Change from Baseline in OHRQoL at 3, 12, 24 adn 36 months OHIP-Edent questionnaire, 20 questions
Change from Baseline in MNA at 3, 12, 24 and 36 months Mini-nutritional Assessement questionnaire (Guigoz 1994)
Change from Baseline in Blood markers at 3, 12, 24 and 36 months Albumin, Folic acid, Vitamin B12 (VitB12), Hemoglobin (Hb), C-reactive protein (CRP)
Change from Insertion in implant survival at 3, 12, 24 and 36 months inserted implants in vivo
Change from Baseline in Maximum bite force at Intervention, 3, 12, 24 and 36 months unilateral maximal bite force measured with force gauge
Change from Baseline in Stimulated Saliva Flow Rate at Intervention, 3, 12, 24 and 36 months whole saliva collected after chewing wax for 2 minutes on one side
Change from Insertion in peri-implant bone loss at 3, 12, 24 and 36 months mesial and distal peri-implant bone loss, as evaluated on intraoral radiographs or OPTs
Changes from Baseline in Masseter Muscle Thickness at 3, 12, 24 and 36 months ultrasound measurements of the masseter muscle thickness in contracted and relaxed state
Change from Baseline in Independence at 12, 24 and 36 months IADL Instrumental Activities of Daily Living Scale (Lawton and Brody, 1969) MIF Measure of functional independence
Change from Insertion in Pocket depth at 3, 12, 24 and 36 months mesial and distal peri-implant probing depth
Change from Baseline in cognitive function at 12, 24 and 36 months Mini-Mental State Examination, to evaluate cognitive function (Folstein et al. 1975) Trail-making test A and B Verbal fluency test
Change from Baseline in BMI at 12, 24 and 36 months Body Mass Index kg/m2
Change from Insertion in Plaque index at 3, 12, 24 and 36 months Plaque index on implants (Silness \& Loe 1963) Denture plaque index
Change from Baseline in Chewing efficiency at Intervention, 3, 12, 24 and 36 months two color mixing test with bi-colored chewing gum (Schimmel et al 2007)
Trial Locations
- Locations (1)
University of Geneva
🇨ðŸ‡Geneva, Switzerland