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The aim of this randomized, controlled, parallel-grouped, clinical trial is to evaluate the width of keratinized gingiva after free gingival graft stabilized by titanium fixation tacs compared to traditional suturing.
Research question:
In patients with inadequate keratinized gingiva undergoing soft tissue augmentation by free gingival graft , will graft stabilization using Titanium fixation tacs affect the amount of keratinized tissue gain compared to graft stabilization using sutures ?
Free gingival graft obtained from the palate, usually replaces missing or lost keratinized tissue. Although it represents the gold standard, its success relies on providing intimate and atraumatic stabilization, as maintaining the plasmatic circulation is crucial for graft healing and perfusion, considering that judging the success of free gingival graftis based on the extent of the postoperative healing contraction and the quality of graft adherence to the underlying periosteum.
Suturing can be time consuming and sometimes fail to achieve a positive result. Also it was reported that for every one-minute increase of the gingival augmentation procedure time, there is a 4% likely increase for pain and a 3% for swelling.
However, by using fixation tacs the surgical time can be significantly reduced and the procedure can be less technique sensitive.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Free gingival graft stabilized by sutures | Active Comparator |
| |
| Free gingival graft stabilized by by Titanium fixation tacs | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Free gingival graft stabilized by Titanium fixation tacs | Procedure | Free gingival graft stabilized by Titanium fixation tacs , in patients with inadequate keratinized gingiva |
|
| Measure | Description | Time Frame |
|---|---|---|
| Width of keratinized gingiva | 6-month |
| Measure | Description | Time Frame |
|---|---|---|
| Surgery time | time spent from the beginning to the end of surgery | Perioperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed Atef Kamal Ibrahim, Bds | Contact | +2001121266030 | mohamed-kamal@dentistry.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Amr Zahran, Professor of Periodontology | Cairo University | Principal Investigator |
| Manar El Zanaty, lecturer of Periodontology | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Cairo University | Recruiting | Cairo | 11511 | Egypt |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 24, 2024 | Dec 31, 2024 |
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| Free gingival graft stabilized by sutures | Procedure | Free gingival graft stabilized by sutures , in patients with inadequate keratinized gingiva |
|
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 13, 2024 | Dec 31, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 29, 2024 | Jan 7, 2025 | ICF_002.pdf |