Within-subject Comparison of Mandibular Overdentures Retained by 1,2,or 3 Implants

Study Overview
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Brief Summary
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This research is being done to find out the ideal number of implants/attachments required to provide adequate stability of dentures during function.

Detailed Description
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The aim of this study is threefold: i) to evaluate within-subject response to complete lower dentures retained by 1 or 2 or 3 implants fitted with independent overdenture attachments; ii) laboratory evaluation of the retention force generated with 1-2 or 3-implants and study its correlation to patients' response; iii) study the wear pattern of the plastic inserts on the overdenture abutments during each retention mode (i.e. the number of implants used to retain the dentures) and correlate its effects to denture stability.

Official Title
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Within-subject Comparison of Mandibular Overdentures Retained by 1,2,or 3 Implants

Conditions
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Complete Edentulism

Intervention / Treatment
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* Other: Questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: subjects completely edentulous on maxilla and mandible for at least a year (w/out dentures) Adult age (25 plus) male or female Stable medical health Ability to participate in the study for at least 3-4 years Able to understand and respond to surveys used in the study Adequate amount of bone in the mandible to receive 3 implants. Exclusion Criteria: history of drug and alcohol abuse, excessive smoking (more than 1 pack/day) surgical limitations: uncontrolled systemic disease: diabetes, etc.. that may compromised healing irradiated surgical site inadequate bone height and width (re: implant size) inability to undergo minor oral surgery because of health or personal reasons psychological and handicapped conditions that may hinder 4-year involvement (physical handicap conditions) Severe TMDs related to joint pathology

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: number of implants<br>number of implants (1,2 or 3) used to retained an overdenture | Other: Questionnaire<br>* 3 surveys with 10 questions each: one before, during and after treatment<br>* Other names: questionnaire for patient satisfaction;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction survey (questionnaires) | Assess efficacy of treatment by analysis of patient's answer to a satisfaction survey. | every 6 months up to three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographs | Assess crestal bone level around the implants. | every 6 months up to three years | 
| Wear of 1 vs 2 vs 3 GPS retention components on complete dentures. | The force required to remove the female retentive componenets from the male component will be compaired between one vs two vs three retentive components. | baseline and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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overdenture, implant, edentulism