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NCT Number: NCT06467630

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Guided Bone Regeneration

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital University of Nantes, Nantes, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

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

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. Post-operative wound healing measured by Early Wound-Healing Index

    Time frame: up to 14 days

    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 2 for this secondary outcome measure.

  2. Post-operative wound healing measured by Early Wound Healing Score

    Time frame: up to 14 days

    For all groups

    The Early Wound Healing Score is from 0 (worse) to 10 (best).

    The EHS is evaluated at the Visit 2 for this secondary outcome measure.

  3. Post-operative clinical exam

    Time frame: up to 6 months

    For all groups

    This is a descriptive secondary outcome measured by the investigator via the reporting of the presence or the absence of:

    • pain,
    • discomfort,
    • inflammation,
    • hematoma, redness,
    • swelling/suppuration,
    • membrane exposure,
    • dehiscence.

    The evaluation is done at visit 2, visit 2Bis, and visit 3.

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

    Time frame: up to 6 months

    For all groups

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

    Time frame: up to 6 months

    For all groups

    The 5 items of OHIP are: Difficulty chewing any foods; Painful aching in the mouth; Felt uncomfortable about the appearance of teeth; Less flavor in the food; and, Difficulty doing the usual jobs.

    Score is from 0 (best) to 20 (worse). The evaluation is done at visit 2 and visit 3.

  6. Radiological measurements on CBCT

    Time frame: up to 6 months

    Only for Post-extraction socket preservation sub-group & for Alveolar ridge augmentation sub-group

    The treatment efficacy is measured via the following measures on CBCT:

    A. Osseous changes in mesiodistal width of the alveolar ridge

    B. Osseous changes in height of the alveolar ridge

    C. Osseous changes in vestibulolingual dimension of the alveolar ridge.

    These changes are evaluated from Baseline to Visit 3.

  7. Radiological measurements on retro-alveolar radios

    Time frame: up to 4 months

    Only for Guided Tissue Regeneration (GTR) during immediate implant placement subgroup.

    The treatment efficacy is measured via the following measures:

    A. Distal vertical situation of the bone plateau compared to the implant by retroalveolar radiography

    B. Mesial vertical situation of the bone plateau compared to the implant by retroalveolar radiography

    C. Insertion Torque Value (Ncm)

    These changes are evaluated from Baseline to Visit 3.

Sponsors and collaborators

Lead sponsor

Septodont

Industry

Registry information

Official study title

Prospective, National, Multicentre and Observational Clinical Investigation of R.T.R.+ Membrane Used in Guided Tissue Regeneration (GTR) in Dental Surgical Procedures

Acronym: ObsR+

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 21, 2024
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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