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Clinical Trials in France / NCT06467630
Active, not recruiting Observational

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

NCT06467630 · tracked via the Priya Life Science France tracker
Sponsor
Septodont
Phase
Observational
Started
2024-02-09
Last updated
2026-05-01

Condition(s) studied

Guided Bone Regeneration

Investigational drug(s) / intervention(s)

Preserving alveolar bone volume after tooth extractionAlveolar crest reconstructionCovering bone defects during immediate implant placement.

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

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

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
89 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Post-operative wound healing measured by the Early Wound-Healing Index — up to 6 months
    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.

Trial sites (9)

FacilityCityRegionStatus
Hospital University of Nantes Nantes France
Private dental practice office of Dr. Alain Hoornaert Nantes France
Private dental practice office of Dr. Samer Saloum-Rouxel Nantes France
Private dental practice office of Dr. Xavier Struillou Nantes France
Private dental practice office of Dr. Edouard Lanoiselée Nozay France
Private dental practice office of Dr. Aurélien Fruchet Olonne-sur-Mer France
Private dental practice office of Dr. Hélène Le Hécho Orée d'Anjou France
Private dental practice office of Dr. Nicolas Strube Orvault France
Private dental practice office of Dr. Romain Besnier Orvault France

More Septodont trials in France

Clinical Investigation Measuring the Long Term Clinical Performance and Safety of Biodentine™ XP in Patients Treated for Coronal Restorative or Endodontic Dental Indications. Recruiting
Root Canal Obturation With a Ready-to-use Root Canal Sealer (PA1704) Versus BioRoot™ RCS: a Randomized Controlled Trial Active, not recruiting
Long-term Performance and Safety of Biodentine™ in Patients Treated for Endodontic Indications Active, not recruiting
Tooth Retention After Root Canal Treatment With Endomethasone N Active, not recruiting
Measurement of the Clinical and Radiological Performance Impact of the Root Canal Treatment With BioRootTM RCS. Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06467630 on ClinicalTrials.gov ↗ ← All trials in France