Edentulous Complete Denture Wearers
Conditions
Keywords
edentulous, complete denture
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.
Interventions
DEVICEImplant placement
Participants received two Straumann Standard Implants® in the interforaminal region using the recommended surgical protocol. The implants were loaded using Locator® attachments after six to eight weeks healing time by transforming the existing lower denture to an IOD.
PROCEDUREConventional reline
conventional reline of the existing mandibular complete denture
Sponsors
University of Geneva, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* severe clinical depression * dementia * poorly controlled diabetes * immunosuppression * treatment with bisphosphonates * condition precluding the surgical intervention for implant placement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 Baseline in BMI | at 12, 24 and 36 months | Body Mass Index kg/m2 |
| Change from Insertion in implant survival | at 3, 12, 24 and 36 months | inserted implants in vivo |
| Change from Baseline in OHRQoL | at 3, 12, 24 adn 36 months | OHIP-Edent questionnaire, 20 questions |
| 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 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 |
| 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) |
| 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 |
| 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 Insertion in Pocket depth | at 3, 12, 24 and 36 months | mesial and distal peri-implant probing depth |
Countries
Switzerland
Outcome results
None listed