Mandibular Implants in Elderly Patients

Study Overview
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Brief Summary
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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.

Official Title
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Implant-supported Mandibular Overdentures in Very Old Adults - a Randomized Controlled Trial

Conditions
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Edentulous Complete Denture Wearers

Intervention / Treatment
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* Device: Implant placement
* Procedure: Conventional reline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: implant placement<br>insertion of 2 interforaminal mandibular implants and conversion of the lower complete denture to an implant-overdenture | Device: Implant placement<br>* 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.<br>* Other names: Locator® attachments (Zest Anchors: Escondido, CA, USA);|
| Active Comparator: denture reline<br>conventional reline of mandibular complete denture | Procedure: Conventional reline<br>* conventional reline of the existing mandibular complete denture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in OHRQoL | OHIP-Edent questionnaire, 20 questions | at 3, 12, 24 adn 36 months | 
| 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 | 
| 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 | 
| Change from Baseline in MNA | Mini-nutritional Assessement questionnaire (Guigoz 1994) | at 3, 12, 24 and 36 months | 
| 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 | 
| Change from Baseline in BMI | Body Mass Index kg/m2 | at 12, 24 and 36 months | 
| Change from Insertion in implant survival | inserted implants in vivo | at 3, 12, 24 and 36 months | 
| Change from Insertion in Pocket depth | mesial and distal peri-implant probing depth | at 3, 12, 24 and 36 months | 
| Change from Insertion in Plaque index | Plaque index on implants (Silness & Loe 1963) Denture plaque index | at 3, 12, 24 and 36 months | 
| 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 | 
| 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 | 
| Change from Baseline in Maximum bite force | unilateral maximal bite force measured with force gauge | at Intervention, 3, 12, 24 and 36 months | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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edentulous, complete denture