Skip to content

Clinical Evaluation of Implant-secured Removable Partial Denture

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02762201
Acronym
PASI-PAC
Enrollment
13
Registered
2016-05-04
Start date
2014-05-16
Completion date
2019-06-06
Last updated
2019-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tooth Loss

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.

Interventions

PROCEDUREPASI

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.

PROCEDUREPAC

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

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
prosthetic success rate5 years after prosthesis delivery

Secondary

MeasureTime frame
prosthetic success rate6 months, 1 year, 2 years, 3 years and 4 years after prosthesis delivery

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026