Measurement of the Performance and Safety of RTR+Membrane in Guided Tissue Regeneration (GTR) in Dental Surgical Procedures

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

RECRUITING

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-09

Study Completion Date

2025-12-31

Brief Summary

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The goal of this observational study is to measure in real practice the performance and safety of RTR+Membrane, a synthetic dental membrane for guided tissue regeneration in periodontal or dental implant surgery. The main question it aims to answer is to measure the post-operative wound healing several months after surgery. Participants will be followed after their dental surgery via clinical examination and radiological and photos images.

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Detailed Description

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Participants are any adult patients with one of the 3 following dental treatments to be done with RTR+Membrane:

* post-extraction socket preservation,
* alveolar ridge augmentation,
* Guided Tissue Regeneration (GTR) during immediate implant placement.

Since it is a real-life evidence study in current practice, patients will be followed at their surgery and their follow-ups. Below are listed visits and type of data collected.

* V1 - Surgery: Demography, Medical history and concomitant treatments, Clinical/technical information (tooth extraction, surgery, membrane and grafting materials use), Clinical Exam, Photography, X-rays or Cone Beam Computed Tomography (CBCT)
* V2 - Early follow-up (including suture removal, if needed): Clinical Exam, Questionnaire, Photography
* V2bis - Early follow-up: Clinical Exam, Photography
* V3 - Late follow-up: Clinical Exam, Photography, X-rays or CBCT, Questionnaire

Conditions

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Guided Bone Regeneration

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Post-extraction socket preservation group

The 30 eligible patients are any male and female, adult patients with the following dental treatment to be done with the study device: Post-extraction socket preservation (not done concomitantly to implant placement).

Preserving alveolar bone volume after tooth extraction

Intervention Type PROCEDURE

* Visit 1: A periodontal or dental implant surgery is done aiming to preserve alveolar bone volume after extraction
* Visit 2 (10 days ± 4 days) - Early post-surgery follow-up
* V2bis (1 month +/- 1 week) - Early post-surgery follow-up
* Visit 3 (5 months ± 1 month) - Late post-surgery follow-up

Alveolar ridge augmentation group

The 30 eligible patients are any male and female, adult patients with the following dental treatment to be done with the study device: Alveolar ridge augmentation (not done concomitantly to implant placement).

Alveolar crest reconstruction

Intervention Type PROCEDURE

* Visit 1: A periodontal or dental implant surgery is done aiming to alveolar crest reconstruction
* Visit 2 (10 days ± 4 days) - Early post-surgery follow-up
* Visit 3 (5 months ± 1 month) - Late post-surgery follow-up

Guided Tissue Regeneration (GTR) during immediate implant placement group

The 30 eligible patients are any male and female, adult patients with the following dental treatment to be done with the study device: Guided Tissue Regeneration (GTR) during immediate implant placement

Covering bone defects during immediate implant placement.

Intervention Type PROCEDURE

* Visit 1: A periodontal or dental implant surgery is done aiming to cover bone defects during immediate implant placement.
* Visit 2 (10 days ± 4 days) - Early post-surgery follow-up
* Visit 3 (3 months ± 1 month) - Late post-surgery follow-up

Interventions

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Preserving alveolar bone volume after tooth extraction

* Visit 1: A periodontal or dental implant surgery is done aiming to preserve alveolar bone volume after extraction
* Visit 2 (10 days ± 4 days) - Early post-surgery follow-up
* V2bis (1 month +/- 1 week) - Early post-surgery follow-up
* Visit 3 (5 months ± 1 month) - Late post-surgery follow-up

Intervention Type PROCEDURE

Alveolar crest reconstruction

* Visit 1: A periodontal or dental implant surgery is done aiming to alveolar crest reconstruction
* Visit 2 (10 days ± 4 days) - Early post-surgery follow-up
* Visit 3 (5 months ± 1 month) - Late post-surgery follow-up

Intervention Type PROCEDURE

Covering bone defects during immediate implant placement.

* Visit 1: A periodontal or dental implant surgery is done aiming to cover bone defects during immediate implant placement.
* Visit 2 (10 days ± 4 days) - Early post-surgery follow-up
* Visit 3 (3 months ± 1 month) - Late post-surgery follow-up

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Male or female adult patient
* Patient with one of the 3 following dental treatments to be done with the study device: post-extraction socket preservation, alveolar ridge augmentation, or Guided Tissue Regeneration (GTR) during immediate implant placement.
* Patient affiliated or beneficiary of a social security system.
* Patient has signed his/her informed consent form.

Exclusion Criteria

* Pregnancy or lactation
* Active tissue infection at the implant site
* Several dental treatments done simultaneously in non-contiguous dental zones
* Heavy smoker (\>10 cigarettes / day)
* Patient receiving long-term corticosteroid therapy, anti-rejection drugs, bisphosphonates, head \& neck radiotherapy or chemotherapy
* Patient with chronic infections (such as osteomyelitis) at the surgical site
* Patient with poorly controlled metabolic disorders (such as diabetes, osteomalacia, thyroid disorders)
* Patient with an auto-immune disease
* Patient under tutelage, vulnerable person, person without liberty, or unable to complete questionnaire independently

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No