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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.
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 dimensions(tissue 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Augmentation of soft tissue by a novel Denuded interpositional pedicled rolled flap technique (DIPRF) |
|
| Control group | Active Comparator | Will be augmented by the conventional subepithelial connective tissue graft technique. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DIPRF | Procedure | Denuded interpositional pedicled rolled flap technique |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ridge contour thickness gain | Ridge contour will be assessed using CBCT analysis using fusion software. The differences between measurement times will indicate the amount of bone gain | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hebattallah A Mattar | Contact | 201207000253 | hebatullah.mater@miuegypt.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Hebattallah A Mattar | Misr International University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Misr International University | Recruiting | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1343013 | Background | Scharf DR, Tarnow DP. Modified roll technique for localized alveolar ridge augmentation. Int J Periodontics Restorative Dent. 1992;12(5):415-25. | |
| 20664835 | Background | Su H, Gonzalez-Martin O, Weisgold A, Lee E. Considerations of implant abutment and crown contour: critical contour and subcritical contour. Int J Periodontics Restorative Dent. 2010 Aug;30(4):335-43. |
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| 36059913 | Background | Ammar AH, Ahmed E, ElBarbary A, Ghalwash D, Ezz Elarab A. Clinical Comparison of the Volumetric Changes in Single Pontic Site Development through Connective Tissue Grafting Using Modified Pouch Technique versus Pouch Technique in the Maxillary Esthetic Zone: A Randomized Controlled Clinical Trial. Int J Dent. 2022 Aug 25;2022:1677471. doi: 10.1155/2022/1677471. eCollection 2022. |