Clinical Evaluation of Implant-secured Removable Partial Denture

NCT ID: NCT02762201

Last Updated: 2019-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-16

Study Completion Date

2019-06-06

Brief Summary

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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.

Detailed Description

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Conditions

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Tooth Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PASI

PASI dental prosthesis delivery

Group Type EXPERIMENTAL

PASI

Intervention Type 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.

PAC

PAC dental prosthesis delivery

Group Type ACTIVE_COMPARATOR

PAC

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospices Civils de Lyon

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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2012-726

Identifier Type: -

Identifier Source: org_study_id

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