Clinical Evaluation of Implant-secured Removable Partial Denture

Study Overview
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Brief Summary
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This study aims to compare the therapeutic efficiency of implant-secured removable partial denture (PASI) with the therapeutic efficiency of the metalic standard removable partial denture (PAC) in the treatment of intermediate extended-gap (4 adjacent teeth). The therapeutic efficiency will be assessed by the 5 years-prosthetic success rate.

Official Title
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Clinical Evaluation of Therapeutic Efficiency of Implant-secured Removable Partial Denture: A Randomized, Controlled, Prospective Multicentric Study.

Conditions
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Tooth Loss

Intervention / Treatment
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* Procedure: PASI
* Procedure: PAC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with at least a 4 to 6 adjacent teeth intermediate extended-gap (excluding wisdom teeth) in the upper or lower jaw. Patients with at least 4 conservable teeth by dental arch, without major occlusal trouble. Patients with healthy periodontium, allowing metalic standard removable partial denture delivery : bleeding on periodontal probing for a duration less than 30 seconds, Osteolysis of the alveolar ridge less or equal to 50%, attachment loss less or equal to 5mm Patients with a sufficient bone volume for implant placement, without prior bone supply. Exclusion Criteria: Patients with general counter-indications for implant placement. Patients suffering from a titanium allergy. Patients with an insufficient oral and dental hygiene - Patients smoking ten or more cigarettes per day. Patients with teeth extended-gap, which could be corrected by a fixed tooth-supported denture. Patient with an insufficient available bite level to deliver an attachment system (< 7mm). Patients with a severe generalized chronic periodontitis , an aggressive periodontitis or a periodontitis unresponsive to treatment. Women who have reported to be pregnant. Patients deprived of liberty

Ages Eligible for Study
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Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PASI<br>PASI dental prosthesis delivery | Procedure: PASI<br>* Implant-secured removable partial denture will be delivered in 2 large steps: implant delivery followed by denture delivery. Implant delivery will take 4 dental consultations : a pre-implant study at Day14 after inclusion, the surgical implant insertion at D28 after inclusion, stitches removal at D35 after inclusion, and finally functional implant delivery between 3 or 6 month after surgery (to allow implant osteointegration). Denture delivery will take 6 weekly dental consultations between Week 3 and Week 8 after the functional implant delivery.<br>|
| Active Comparator: PAC<br>PAC dental prosthesis delivery | Procedure: PAC<br>* Metalic standard removable partial denture, the standard treatment, will be delivered in 4 steps at Day 7, D14, D21, D28 after inclusion, as classically.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prosthetic success rate |  | 5 years after prosthesis delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prosthetic success rate |  | 6 months, 1 year, 2 years, 3 years and 4 years after prosthesis delivery |