Guided Bone RegenerationObsR+NCT06467630
Measurement of the Performance and Safety of RTR+Membrane in Guided Tissue Regeneration (GTR) in Dental Surgical Procedures
An observational study of Guided Bone Regeneration, run by Septodont at 9 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Guided Bone Regeneration
- What is being tested?
- Preserving alveolar bone volume after tooth extraction, Alveolar crest reconstruction and Covering bone defects during immediate implant placement.
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 9 sitesFrance
- Study dates
- 9 Feb 2024to May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible patients are any male and female, adult patients with one of the 3 following dental treatments to be done with the study device: * post-extraction socket preservation*, * alveolar ridge augmentation*, * Guided Tissue Regeneration (GTR) during immediate implant placement. The dental treatment under investigation for one patient could be related to: * 1 alveolar socket corresponding to only 1 tooth; * 1 implant to be placed in replacement of 1 tooth; * several contiguous alveolar sockets; * Or, several contiguous implants to be placed. Dental treatments done simultaneously in non-contiguous dental zones won't be considered for this study.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Hospital University of Nantes
Nantes, 44000
Private dental practice office of Dr. Alain Hoornaert
Nantes, 44000
Private dental practice office of Dr. Samer Saloum-Rouxel
Nantes, 44000
Private dental practice office of Dr. Xavier Struillou
Nantes, 44000
Private dental practice office of Dr. Edouard Lanoiselée
Nozay, 44170
Private dental practice office of Dr. Aurélien Fruchet
Olonne-sur-Mer, 85340
Private dental practice office of Dr. Hélène Le Hécho
Orée d'Anjou, 49530
Private dental practice office of Dr. Nicolas Strube
Orvault, 44700
Private dental practice office of Dr. Romain Besnier
Orvault, 44700
About this study
Official title: Prospective, National, Multicentre and Observational Clinical Investigation of R.T.R.+ Membrane Used in Guided Tissue Regeneration (GTR) in Dental Surgical Procedures
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.
Read the 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
- Conditions
- Guided Bone Regeneration
- Being tested
- Preserving alveolar bone volume after tooth extraction, Alveolar crest reconstruction, Covering bone defects during immediate implant placement.
- Keywords
- Guided Bone Regeneration, Dental surgical procedures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preserving alveolar bone volume after tooth extractionProcedure or surgery
- 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 or surgery
- 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 or surgery
- 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
| Study group | Role | What they receive |
|---|---|---|
| Post-extraction socket preservation group | 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). Receives: Procedure: Preserving alveolar bone volume after tooth extraction | |
| Alveolar ridge augmentation group | 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). Receives: Procedure: Alveolar crest reconstruction | |
| Guided Tissue Regeneration (GTR) during immediate implant placement group | 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 Receives: Procedure: Covering bone defects during immediate implant placement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 6 months
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: up to 6 months
Number of adverse device effects (at least possibly) related to study device
For all groups
Measured: 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.
Measured: 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:
- Osseous changes in mesiodistal width of the alveolar ridge
- Osseous changes in height of the alveolar ridge
- Osseous changes in vestibulolingual dimension of the alveolar ridge.
These changes are evaluated from Baseline to Visit 3.
Measured: 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:
- Distal vertical situation of the bone plateau compared to the implant by retroalveolar radiography
- Mesial vertical situation of the bone plateau compared to the implant by retroalveolar radiography
- Insertion Torque Value (Ncm)
These changes are evaluated from Baseline to Visit 3.
Measured: up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start9 Feb 2024
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Guided Bone RegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Septodont
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alain Hoornaert, DDS, Principal investigator, University Hospital of Nantes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06467630
- Sponsor's protocol ID
- RTR+ 2023-01
- Acronym
- ObsR+
- Status last verified
- Apr 2026
- First submitted
- 2 Jan 2024
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, National, Multicentre and Observational Clinical Investigation of R.T.R.+ Membrane Used in Guided Tissue Regeneration (GTR) in Dental Surgical Procedures
- ClinicalTrials.gov ID
- NCT06467630
- Acronym / sponsor ID
- ObsR+ / RTR+ 2023-01
- Conditions
- Guided Bone Regeneration
- Keywords
- Guided Bone Regeneration, Dental surgical procedures
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- SeptodontIndustry (pharma, biotech, devices)
- Study start
- 9 Feb 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Post-extraction socket preservation group | – | Procedure: Preserving alveolar bone volume after tooth extractionThe 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). |
| Alveolar ridge augmentation group | – | Procedure: Alveolar crest reconstructionThe 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). |
| Guided Tissue Regeneration (GTR) during immediate implant placement group | – | Procedure: 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 |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients are any male and female, adult patients with one of the 3 following dental treatments to be done with the study device: * post-extraction socket preservation*, * alveolar ridge augmentation*, * Guided Tissue Regeneration (GTR) during immediate implant placement. The dental treatment under investigation for one patient could be related to: * 1 alveolar socket corresponding to only 1 tooth; * 1 implant to be placed in replacement of 1 tooth; * several contiguous alveolar sockets; * Or, several contiguous implants to be placed. Dental treatments done simultaneously in non-contiguous dental zones won't be considered for this study.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | Post-extraction socket preservation group |
| 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 | Procedure or surgery | Alveolar ridge augmentation group |
| 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 | Procedure or surgery | Guided Tissue Regeneration (GTR) during immediate implant placement group |
Primary outcome
Post-operative wound healing measured by the Early Wound-Healing Index
Time frame: 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.
7 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
Time frame: up to 14 days
Post-operative clinical exam
Time frame: up to 6 months
Number of adverse device effects (at least possibly) related to study device
Time frame: up to 6 months
Oral Health-Related Quality of Life measured by the Oral Health Impact Profile (OHIP-5 items)
Time frame: up to 6 months
Radiological measurements on CBCT
Time frame: up to 6 months
Radiological measurements on retro-alveolar radios
Time frame: up to 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain Hoornaert, DDS principal investigator
University Hospital of Nantes
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Guided Bone Regeneration, run by Septodont at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative wound healing measured by the Early Wound-Healing Index (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.