Measurement of the Performance and Safety of RTR+Membrane in Guided Tissue Regeneration (GTR) in Dental Surgical Procedures (ObsR+)
Prospective, National, Multicentre and Observational Clinical Investigation of R.T.R.+ Membrane Used in Guided Tissue Regeneration (GTR) in Dental Surgical Procedures
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Nantes, France, 44000
- Hospital University of Nantes
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Nantes, France, 44000
- Private dental practice office of Dr. Alain Hoornaert
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Nantes, France, 44000
- Private dental practice office of Dr. Samer Saloum-Rouxel
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Nantes, France, 44000
- Private dental practice office of Dr. Xavier Struillou
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Nozay, France, 44170
- Private dental practice office of Dr. Edouard Lanoiselée
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Olonne-sur-Mer, France, 85340
- Private dental practice office of Dr. Aurélien Fruchet
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Orvault, France, 44700
- Private dental practice office of Dr. Nicolas Strube
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Orvault, France, 44700
- Private dental practice office of Dr. Romain Besnier
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Orée d'Anjou, France, 49530
- Private dental practice office of Dr. Hélène Le Hécho
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
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.
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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).
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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).
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post-operative wound healing measured by the Early Wound-Healing Index
Time Frame: up to 6 months
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Post-operative wound healing measured by Early Wound-Healing Index
Time Frame: up to 14 days
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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
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Post-operative wound healing measured by Early Wound Healing Score
Time Frame: up to 14 days
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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
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Post-operative clinical exam
Time Frame: up to 6 months
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For all groups This is a descriptive secondary outcome measured by the investigator via the reporting of the presence or the absence of:
The evaluation is done at visit 2, visit 2Bis, and visit 3. |
up to 6 months
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Number of adverse device effects (at least possibly) related to study device
Time Frame: up to 6 months
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For all groups
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up to 6 months
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Oral Health-Related Quality of Life measured by the Oral Health Impact Profile (OHIP-5 items)
Time Frame: up to 6 months
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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
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Radiological measurements on CBCT
Time Frame: up to 6 months
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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
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Radiological measurements on retro-alveolar radios
Time Frame: up to 4 months
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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
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alain Hoornaert, DDS, University Hospital of Nantes
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RTR+ 2023-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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