Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06435780
Status:
RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-02-04
Brief Title:
Novel Technique Versus Conventional Subepithelial Connective Tissue Graft in Treatment of Ridge Contour Defects
Sponsor:
Misr International University
Organization:
Misr International University
Study Overview
Official Title:
Evaluation of a Novel Technique Versus Conventional Subepithelial Connective Tissue Graft in Treatment of Ridge Contour Defects A Randomized Controlled Clinical Trial
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:
None
Brief Summary:
The aim of the study is to clinically and radiographically evaluate and compare two techniques to augment soft tissues the conventional subepithelial connective tissue graft technique and a novel denuded interpositional pedicled rolled flap technique DIPRF These techniques will be used to augment edentulous ridges that are recommended for rehabilitation by an implant or a fixed restoration
Detailed Description:
Fifty patients with soft tissue ridge contour defects in the maxillary premolar region and recommended for rehabilitation by an implant or a fixed restoration will be enrolled Patients will be allocated randomly into two groups group 1 test group will have augmentation for their soft tissue by a novel Denuded interpositional pedicled rolled flap technique DIPRF group 2 control group will be augmented by the conventional subepithelial connective tissue graft technique Clinical volumetric change evaluation and ridge thickness analysis using digitally calibrated casts and CBCT analysis with a fusion software will be performed for every site as well as periodontal evaluation and patient centered outcomes including pain and satisfaction after the procedure will be recorded for both techniques For each site an impression will be used to pour a cast that will be digitally scanned and vertical and horizontal ridge contours dimensionstissue volumetric changes will be recorded These measurements will be obtained before the surgical procedure 2 weeks and 3 and 6 months post-surgical CBCT analysis will be performed pre-operatively to confirm the diagnosis and eligibility of the case as having only soft tissue defect without bone defects and 6 months postoperatively to analyze the amount of soft tissue gain in the two groups
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