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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.
Participants are any adult patients with one of the 3 following dental treatments to be done with RTR+Membrane:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preserving alveolar bone volume after tooth extraction | Procedure |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Eligible patients are any male and female, adult patients with one of the 3 following dental treatments to be done with the study device:
The dental treatment under investigation for one patient could be related to:
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| Name | Affiliation | Role |
|---|---|---|
| Alain Hoornaert, DDS | University Hospital of Nantes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital University of Nantes | Nantes | 44000 | France | |||
| Private dental practice office of Dr. Alain Hoornaert |
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| Alveolar crest reconstruction | Procedure |
|
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| Covering bone defects during immediate implant placement. | Procedure |
|
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| 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:
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 |
| 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. Hélène Le Hécho | Orée d'Anjou | 49530 | France |
| Private dental practice office of Dr. Nicolas Strube | Orvault | 44700 | France |
| Private dental practice office of Dr. Romain Besnier | Orvault | 44700 | France |