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

Guided Bone Regeneration Clinical Trial

— ObsR+  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06467630
• Other study ID #: RTR+ 2023-01
• Status: Recruiting
• Start date: February 9, 2024
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: Septodont
• Contact: CCP from the Sponsor
• Phone: +33 1 49 76 70 00
• Email: clinical-operations[@]septodont.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Guided Bone Regeneration

Intervention

Procedure:
• Preserving alveolar bone volume after tooth extraction
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
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.
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

Locations

Country	Name	City	State
France	Hospital University of Nantes	Nantes
France	Private dental practice office of Dr. Alain Hoornaert	Nantes
France	Private dental practice office of Dr. Samer Saloum-Rouxel	Nantes
France	Private dental practice office of Dr. Xavier Struillou	Nantes
France	Private dental practice office of Dr. Edouard Lanoiselée	Nozay
France	Private dental practice office of Dr. Aurélien Fruchet	Olonne-sur-Mer
France	Private dental practice office of Dr. Hélène Le Hécho	Orée d'Anjou
France	Private dental practice office of Dr. Nicolas Strube	Orvault
France	Private dental practice office of Dr. Romain Besnier	Orvault

Sponsors (1)

Lead Sponsor	Collaborator
Septodont

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Number of adverse device effects (at least possibly) related to study device	For all groups	up to 6 months
Secondary	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
Secondary	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
Secondary	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