Ignite Creation Date:
2024-07-17 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06467630
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-01-02
Brief Title:
Measurement of the Performance and Safety of RTRMembrane in Guided Tissue Regeneration GTR in Dental Surgical Procedures
Sponsor:
Septodont
Organization:
Septodont
Study Overview
Official Title:
Prospective National Multicentre and Observational Clinical Investigation of RTR Membrane Used in Guided Tissue Regeneration GTR in Dental Surgical Procedures
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ObsR
Brief Summary:
The goal of this observational study is to measure in real practice the performance and safety of RTRMembrane 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 RTRMembrane
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 Clinicaltechnical 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
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 Clinicaltechnical 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None