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

Last updated: June 14, 2024
Sponsor: Septodont
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Alveolar crest reconstruction

Preserving alveolar bone volume after tooth extraction

Covering bone defects during immediate implant placement.

Clinical Study ID

NCT06467630
RTR+ 2023-01
  • Ages 18-89
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Male or female adult patient

  • Patient with one of the 3 following dental treatments to be done with the studydevice: post-extraction socket preservation, alveolar ridge augmentation, or GuidedTissue Regeneration (GTR) during immediate implant placement.

  • Patient affiliated or beneficiary of a social security system.

  • Patient has signed his/her informed consent form.

Exclusion

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 tocomplete questionnaire independently

Study Design

Total Participants: 90
Treatment Group(s): 3
Primary Treatment: Alveolar crest reconstruction
Phase:
Study Start date:
February 09, 2024
Estimated Completion Date:
December 31, 2025

Study Description

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

Connect with a study center

  • Hospital University of Nantes

    Nantes, 44000
    France

    Active - Recruiting

  • Private dental practice office of Dr. Alain Hoornaert

    Nantes, 44000
    France

    Active - Recruiting

  • Private dental practice office of Dr. Samer Saloum-Rouxel

    Nantes, 44000
    France

    Site Not Available

  • Private dental practice office of Dr. Xavier Struillou

    Nantes, 44000
    France

    Site Not Available

  • Private dental practice office of Dr. Edouard Lanoiselée

    Nozay, 44170
    France

    Site Not Available

  • Private dental practice office of Dr. Aurélien Fruchet

    Olonne-sur-Mer, 85340
    France

    Site Not Available

  • Private dental practice office of Dr. Nicolas Strube

    Orvault, 44700
    France

    Site Not Available

  • Private dental practice office of Dr. Romain Besnier

    Orvault, 44700
    France

    Site Not Available

  • Private dental practice office of Dr. Hélène Le Hécho

    Orée d'Anjou, 49530
    France

    Active - Recruiting

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