Measurement of the Performance and Safety of RTR+Membrane in Guided Tissue Regeneration (GTR) in Dental Surgical Procedures
- Conditions
- Guided Bone Regeneration
- Interventions
- Procedure: Alveolar crest reconstructionProcedure: Preserving alveolar bone volume after tooth extractionProcedure: Covering bone defects during immediate implant placement.
- Registration Number
- NCT06467630
- Lead Sponsor
- Septodont
- Brief 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.
- Detailed 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Alveolar ridge augmentation group Alveolar crest reconstruction 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). Post-extraction socket preservation group Preserving alveolar bone volume after tooth extraction 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). Guided Tissue Regeneration (GTR) during immediate implant placement group Covering bone defects during immediate implant placement. 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
- Primary Outcome Measures
Name Time Method Post-operative wound healing measured by the Early Wound-Healing Index 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 Outcome Measures
Name Time Method Post-operative wound healing measured by Early Wound-Healing Index 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.Post-operative clinical exam 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.Post-operative wound healing measured by Early Wound Healing Score 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.Oral Health-Related Quality of Life measured by the Oral Health Impact Profile (OHIP-5 items) 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.Radiological measurements on CBCT 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.Radiological measurements on retro-alveolar radios 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.Number of adverse device effects (at least possibly) related to study device up to 6 months For all groups
Trial Locations
- Locations (9)
Private dental practice office of Dr. Xavier Struillou
🇫🇷Nantes, France
Private dental practice office of Dr. Samer Saloum-Rouxel
🇫🇷Nantes, France
Hospital University of Nantes
🇫🇷Nantes, France
Private dental practice office of Dr. Alain Hoornaert
🇫🇷Nantes, France
Private dental practice office of Dr. Edouard Lanoiselée
🇫🇷Nozay, France
Private dental practice office of Dr. Romain Besnier
🇫🇷Orvault, France
Private dental practice office of Dr. Nicolas Strube
🇫🇷Orvault, France
Private dental practice office of Dr. Hélène Le Hécho
🇫🇷Orée d'Anjou, France
Private dental practice office of Dr. Aurélien Fruchet
🇫🇷Olonne-sur-Mer, France