Clinical Evaluation of Implant-secured Removable Partial Denture

NCT02762201 | Terminated

• 1 other identifier: 2012-726
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tooth Loss

Outcome Measures

Primary Outcomes (1)

• prosthetic success rate

  5 years after prosthesis delivery

Secondary Outcomes (1)

• prosthetic success rate

  6 months, 1 year, 2 years, 3 years and 4 years after prosthesis delivery

Study Arms (2)

PASI

EXPERIMENTAL

PASI dental prosthesis delivery

Procedure: PASI

PAC

ACTIVE COMPARATOR

PAC dental prosthesis delivery

Procedure: PAC

Interventions

PASI PROCEDURE

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.

PASI

PAC PROCEDURE

Metalic standard removable partial denture, the standard treatment, will be delivered in 4 steps at Day 7, D14, D21, D28 after inclusion, as classically.

PAC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon

Lyon, France

Location

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: May 4, 2016
• Study Start: May 16, 2014
• Primary Completion: June 6, 2019
• Study Completion: June 6, 2019
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)