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

Septodont

Status: Enrolling

Conditions: Guided Bone Regeneration

Treatments: Procedure: Covering bone defects during immediate implant placement.; Procedure: Preserving alveolar bone volume after tooth extraction; Procedure: Alveolar crest reconstruction

Study type: Observational

Funder types: Industry

Identifiers

NCT06467630

RTR+ 2023-01

Details and patient eligibility

About

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.

Full 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

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

90 participants in 3 patient groups

Post-extraction socket preservation group

Description:

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).

Treatment:

Procedure: Preserving alveolar bone volume after tooth extraction

Alveolar ridge augmentation group

Description:

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).

Treatment:

Procedure: Alveolar crest reconstruction

Guided Tissue Regeneration (GTR) during immediate implant placement group

Description:

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

Treatment:

Procedure: Covering bone defects during immediate implant placement.