Edentulous Complete Denture Wearers Clinical Trial
Official title:
Implant-supported Mandibular Overdentures in Very Old Adults - a Randomized Controlled Trial
| Verified date | April 2021 |
| Source | University of Geneva, Switzerland |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 45 |
| Est. completion date | April 2019 |
| Est. primary completion date | April 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 75 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | University of Geneva | Geneva |
| Lead Sponsor | Collaborator |
|---|---|
| University of Geneva, Switzerland |
Switzerland,
Maniewicz S, Duvernay E, Srinivasan M, Perneger T, Schimmel M, Müller F. Effect of implant-supported mandibular overdentures versus reline on masticatory performance and salivary flow rates in very old adults-A randomized clinical trial. Clin Oral Implant — View Citation
Müller F, Duvernay E, Loup A, Vazquez L, Herrmann FR, Schimmel M. Implant-supported mandibular overdentures in very old adults: a randomized controlled trial. J Dent Res. 2013 Dec;92(12 Suppl):154S-60S. doi: 10.1177/0022034513509630. Epub 2013 Oct 24. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from Baseline in Denture satisfaction | VAS-scale score to evaluate the subjective satisfaction with the denture | at 3, 12, 24 and 36 months | |
| Secondary | Change from Baseline in OHRQoL | OHIP-Edent questionnaire, 20 questions | at 3, 12, 24 adn 36 months | |
| Secondary | Change from Baseline in cognitive function | Mini-Mental State Examination, to evaluate cognitive function (Folstein et al. 1975) Trail-making test A and B Verbal fluency test | at 12, 24 and 36 months | |
| Secondary | Change from Baseline in Independence | IADL Instrumental Activities of Daily Living Scale (Lawton and Brody, 1969) MIF Measure of functional independence | at 12, 24 and 36 months | |
| Secondary | Change from Baseline in MNA | Mini-nutritional Assessement questionnaire (Guigoz 1994) | at 3, 12, 24 and 36 months | |
| Secondary | Change from Baseline in Blood markers | Albumin, Folic acid, Vitamin B12 (VitB12), Hemoglobin (Hb), C-reactive protein (CRP) | at 3, 12, 24 and 36 months | |
| Secondary | Change from Baseline in BMI | Body Mass Index kg/m2 | at 12, 24 and 36 months | |
| Secondary | Change from Insertion in implant survival | inserted implants in vivo | at 3, 12, 24 and 36 months | |
| Secondary | Change from Insertion in Pocket depth | mesial and distal peri-implant probing depth | at 3, 12, 24 and 36 months | |
| Secondary | Change from Insertion in Plaque index | Plaque index on implants (Silness & Loe 1963) Denture plaque index | at 3, 12, 24 and 36 months | |
| Secondary | Change from Insertion in peri-implant bone loss | mesial and distal peri-implant bone loss, as evaluated on intraoral radiographs or OPTs | at 3, 12, 24 and 36 months | |
| Secondary | Change from Baseline in Chewing efficiency | two color mixing test with bi-colored chewing gum (Schimmel et al 2007) | at Intervention, 3, 12, 24 and 36 months | |
| Secondary | Change from Baseline in Maximum bite force | unilateral maximal bite force measured with force gauge | at Intervention, 3, 12, 24 and 36 months | |
| Secondary | Change from Baseline in Stimulated Saliva Flow Rate | whole saliva collected after chewing wax for 2 minutes on one side | at Intervention, 3, 12, 24 and 36 months | |
| Secondary | Changes from Baseline in Masseter Muscle Thickness | ultrasound measurements of the masseter muscle thickness in contracted and relaxed state | at 3, 12, 24 and 36 months |