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

Septodont90 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Guided Bone Regeneration

Interventions

Preserving alveolar bone volume after tooth extractionPROCEDURE

* 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 reconstructionPROCEDURE

* 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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 Years

Medical Language ↔ Plain English

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

Locations (9)

Hospital University of Nantes

Nantes, France

RECRUITING

Private dental practice office of Dr. Alain Hoornaert

Nantes, France

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: up to 6 months

Secondary Outcomes

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

Time frame: up to 14 days

Post-operative wound healing measured by Early Wound Healing Score

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.

Time frame: up to 14 days

Post-operative clinical exam

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.

Central Contacts

CCP from the Sponsor

CONTACT

+33 1 49 76 70 00 clinical-operations@septodont.com

Data from ClinicalTrials.gov

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