Free Gingival Grafts for Keratinization Deficiency
Trial Summary
What is the purpose of this trial?
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.
Research Team
Tatakis Dimitris, DDS, PhD
Principal Investigator
The Ohio State University Graduate Periodontics Program Director
Eligibility Criteria
This trial is for patients needing a gum graft in the lower back mouth area, who haven't used tobacco or nicotine products for at least 5 years. They must be physically and mentally fit with no issues that would complicate periodontal surgery, have healthy gums, and can consent to treatment. Surgery is scheduled for Tuesdays.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Surgery
Participants undergo the free gingival graft procedure with either partial or full-thickness bed preparation
Post-operative Follow-up
Participants are monitored for wound healing, graft stability, and pain assessment
Operator Assessment
Operators assess surgical difficulty and preference after completing all cases
Treatment Details
Interventions
- Bone screw (FDA approved bone screw)
- Full thickness recipient bed
- Partial thickness recipient bed
- Periosteal sutures
- Sling sutures
- Sling sutures around screws
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ohio State University
Lead Sponsor