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

NCT06467630 | Active Not Recruiting

• 1 other identifier: RTR+ 2023-01
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Guided Bone Regeneration

Keywords

Guided Bone Regeneration; Dental surgical procedures

Outcome Measures

Primary Outcomes (1)

• Post-operative wound healing measured by the Early Wound-Healing Index

  For all groups The Early Wound-Healing Index (EHI) has the following best to worst scoring: (EHI) 1: complete flap closure without fibrin line in the interproximal area. (EHI) 2: complete flap closure with fine fibrin line in the interproximal area. (EHI) 3: complete flap closure with fibrin clot in the interproximal area. (EHI) 4: incomplete flap closure with partial necrosis of the interproximal tissue. (EHI) 5: incomplete flap closure with complete necrosis of the interproximal tissue. The EHI is evaluated at the Visit 3 (late post-surgery follow-up) for the primary outcome measure.

  up to 6 months

Secondary Outcomes (7)

• Post-operative wound healing measured by Early Wound-Healing Index

  up to 14 days

• Post-operative wound healing measured by Early Wound Healing Score

  up to 14 days

• Post-operative clinical exam

  up to 6 months

• Number of adverse device effects (at least possibly) related to study device

  up to 6 months

• Oral Health-Related Quality of Life measured by the Oral Health Impact Profile (OHIP-5 items)

  up to 6 months

Study Arms (3)

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).

Procedure: Preserving alveolar bone volume after tooth extraction

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).

Procedure: Alveolar crest reconstruction

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

Procedure: Covering bone defects during immediate implant placement.

Interventions

Preserving alveolar bone volume after tooth extraction 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

Post-extraction socket preservation group

Alveolar crest reconstruction 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

Alveolar ridge augmentation group

Covering bone defects during immediate implant placement. 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

Guided Tissue Regeneration (GTR) during immediate implant placement group

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible patients are any male and female, adult patients with one of the 3 following dental treatments to be done with the study device: * post-extraction socket preservation\*, * alveolar ridge augmentation\*, * Guided Tissue Regeneration (GTR) during immediate implant placement. The dental treatment under investigation for one patient could be related to: * 1 alveolar socket corresponding to only 1 tooth; * 1 implant to be placed in replacement of 1 tooth; * several contiguous alveolar sockets; * Or, several contiguous implants to be placed. Dental treatments done simultaneously in non-contiguous dental zones won't be considered for this study.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Septodont: lead

Study Sites (9)

Hospital University of Nantes

Nantes, 44000, France

Location

Private dental practice office of Dr. Alain Hoornaert

Nantes, 44000, France

Location

Private dental practice office of Dr. Samer Saloum-Rouxel

Nantes, 44000, France

Location

Private dental practice office of Dr. Xavier Struillou

Nantes, 44000, France

Location

Private dental practice office of Dr. Edouard Lanoiselée

Nozay, 44170, France

Location

Private dental practice office of Dr. Aurélien Fruchet

Olonne-sur-Mer, 85340, France

Location

Private dental practice office of Dr. Hélène Le Hécho

Orée d'Anjou, 49530, France

Location

Private dental practice office of Dr. Nicolas Strube

Orvault, 44700, France

Location

Private dental practice office of Dr. Romain Besnier

Orvault, 44700, France

Location

Study Officials

• Alain Hoornaert, DDS

  University Hospital of Nantes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: June 21, 2024
• Study Start: February 9, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (9)