Clinical Evaluation of Implant-secured Removable Partial Denture (PASI-PAC)

August 22, 2019 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France
        • Hospices Civils de Lyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PASI
PASI dental prosthesis delivery
Procedure: PASI

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.
Active Comparator: PAC
PAC dental prosthesis delivery
Procedure: PAC
Metalic standard removable partial denture, the standard treatment, will be delivered in 4 steps at Day 7, D14, D21, D28 after inclusion, as classically.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
prosthetic success rate
Time Frame: 5 years after prosthesis delivery
5 years after prosthesis delivery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2014

Primary Completion (Actual)

June 6, 2019

Study Completion (Actual)

June 6, 2019

Study Registration Dates

First Submitted

May 3, 2016

First Submitted That Met QC Criteria

May 3, 2016

First Posted (Estimate)

May 4, 2016

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 22, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-726

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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