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

Primary Purpose

Tooth Loss

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PASI
PAC
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospices Civils de Lyon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PASI

PAC

Arm Description

PASI dental prosthesis delivery

PAC dental prosthesis delivery

Outcomes

Primary Outcome Measures

prosthetic success rate

Secondary Outcome Measures

prosthetic success rate

Full Information

First Posted
May 3, 2016
Last Updated
August 22, 2019
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02762201
Brief Title
Clinical Evaluation of Implant-secured Removable Partial Denture
Acronym
PASI-PAC
Official Title
Clinical Evaluation of Therapeutic Efficiency of Implant-secured Removable Partial Denture: A Randomized, Controlled, Prospective Multicentric Study.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
Sponsor and principal investigator decision
Study Start Date
May 16, 2014 (Actual)
Primary Completion Date
June 6, 2019 (Actual)
Study Completion Date
June 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PASI
Arm Type
Experimental
Arm Description
PASI dental prosthesis delivery
Arm Title
PAC
Arm Type
Active Comparator
Arm Description
PAC dental prosthesis delivery
Intervention Type
Procedure
Intervention Name(s)
PASI
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
PAC
Intervention Description
Metalic standard removable partial denture, the standard treatment, will be delivered in 4 steps at Day 7, D14, D21, D28 after inclusion, as classically.
Primary Outcome Measure Information:
Title
prosthetic success rate
Time Frame
5 years after prosthesis delivery
Secondary Outcome Measure Information:
Title
prosthetic success rate
Time Frame
6 months, 1 year, 2 years, 3 years and 4 years after prosthesis delivery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hospices Civils de Lyon
City
Lyon
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Evaluation of Implant-secured Removable Partial Denture

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