Measurement of the Performance and Safety of RTR+Membrane in Guided Tissue Regeneration (GTR) in Dental Surgical Procedures
NCT Number: NCT06467630
Acronym: ObsR+
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Guided Bone Regeneration
Interventions: PROCEDURE: Preserving alveolar bone volume after tooth extraction|PROCEDURE: Alveolar crest reconstruction|PROCEDURE: Covering bone defects during immediate implant placement.
Sponsor: Septodont
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-02-09
Completion Date: 2025-12
Locations: Hospital University of Nantes, Nantes, 44000, France|Private dental practice office of Dr. Alain Hoornaert, Nantes, 44000, France|Private dental practice office of Dr. Samer Saloum-Rouxel, Nantes, 44000, France|Private dental practice office of Dr. Xavier Struillou, Nantes, 44000, France|Private dental practice office of Dr. Edouard Lanoiselée, Nozay, 44170, France|Private dental practice office of Dr. Aurélien Fruchet, Olonne-sur-Mer, 85340, France|Private dental practice office of Dr. Nicolas Strube, Orvault, 44700, France|Private dental practice office of Dr. Romain Besnier, Orvault, 44700, France|Private dental practice office of Dr. Hélène Le Hécho, Orée d'Anjou, 49530, France

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.

Primary Outcome Measures: 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., up to 6 months
Secondary Outcome Measures: Post-operative wound healing measured by 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 2 for this secondary outcome measure., 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., 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., up to 6 months|Number of adverse device effects (at least possibly) related to study device, For all groups, up to 6 months|Oral Health-Related Quality of Life measured by the Oral Health Impact Profile (OHIP-5 items), 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., up to 6 months|Radiological measurements on CBCT, 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., up to 6 months|Radiological measurements on retro-alveolar radios, 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., up to 4 months