Guided Bone Regeneration
Conditions
Keywords
Guided Bone Regeneration, Dental surgical procedures
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
Interventions
PROCEDUREPreserving 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
PROCEDUREAlveolar 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
PROCEDURECovering 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
Sponsors
Septodont
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
| Number of adverse device effects (at least possibly) related to study device | up to 6 months | For all groups |
| 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. |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORAlain Hoornaert, DDS
University Hospital of Nantes
Outcome results
None listed