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NCT04099680
Free Gingival Grafts (FGGs) in Mandibular Posterior Sites
NA trial testing Partial thickness recipient bed in Lack of Keratinized Tissue in 13 participants. Status unknown.
15 April 2025
Quick facts
| Lead sponsor | Ohio State University |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 13 |
| Start date | 31 December 2020 |
| Primary completion | 15 April 2025 |
| Estimated completion | 15 April 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Partial thickness recipient bed
- Full thickness recipient bed
- Bone screw (FDA approved bone screw)
- Periosteal sutures
- Sling sutures
- Sling sutures around screws
Conditions studied
- Lack of Keratinized Tissue — all drugs for Lack of Keratinized Tissue →
Sponsor
Ohio State University
Who can join
Adults 35 to 70, any sex, with Lack of Keratinized Tissue. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In this proposed study a novel technique that utilizes bone screws as an anchorage device will be used to facilitate suturing and ensure graft tissue immobilization on full thickness recipient bed preparation sites. Currently, no information is available on free gingival graft treatment outcomes comparing full thickness recipient bed preparation, i.e., no periosteum remaining under the free gingival graft, with the aid of bone screws versus a conventional partial thickness recipient bed preparation with periosteum remaining under the graft. The purpose of the present study is to investigate the effect of these two different recipient bed preparations on soft tissue dimension change, graft and surgical wound healing, patient comfort, surgical complication frequency and operator satisfaction after free gingival graft to increase the width of keratinized gingival tissue in mandibular posterior sites. The purpose of the present study is to investigate the effect of these two different recipient bed preparations on soft tissue dimension change, graft and surgical wound healing, patient comfort, surgical complication frequency and operator satisfaction after free gingival graft procedure to increase the width of keratinized gingival tissue in mandibular posterior sites. The specific aims of this research study contain two aspects: 1. To compare the wound healing of a free gingival graft using either a partial thickness flap or full-thickness flap preparation with bone screws at the recipient site around mandibular posterior areas. 2. To assess patient comfort and surgeon satisfaction with a free gingival graft procedure using these two different recipient bed preparations.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04099680 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ohio State University
- Last refreshed: 10 May 2024
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