Clinical Evaluation of Implant-secured Removable Partial Denture

Tooth Loss Clinical Trial

— PASI-PAC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02762201
• Other study ID #: 2012-726
• Status: Terminated
• Phase: N/A
• Start date: May 16, 2014
• Est. completion date: June 6, 2019

Study information

• Verified date: August 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: June 6, 2019
• Est. primary completion date: June 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tooth Loss

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prosthetic success rate		5 years after prosthesis delivery
Secondary	prosthetic success rate		6 months, 1 year, 2 years, 3 years and 4 years after prosthesis delivery