Free Gingival Grafts for Keratinization Deficiency
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores two methods for preparing the tissue bed for gum grafts, which increase the band of tough, protective gum tissue in the lower jaw. One method uses FDA-approved bone screws to anchor the graft, while the other employs a traditional technique without screws. Researchers aim to determine which method provides better healing, more comfort, and fewer complications. Individuals with healthy gums who need a gum graft in the back of their lower jaw might be suitable candidates. As an unphased trial, this study allows patients to contribute to innovative research that could enhance future gum graft procedures.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are taking medications that affect surgical or wound healing, you may not be eligible to participate.
What prior data suggests that this technique is safe for gingival graft procedures?
Research has shown that free gingival grafts (FGGs) are generally safe. Studies on the full-thickness method have not identified any major safety issues. However, limited data directly compares full-thickness and partial-thickness methods.
Reports indicate that FGGs often lead to stable results, with some cases showing good outcomes for up to 13 years, suggesting long-term safety and effectiveness. The partial-thickness method has proven effective and reliable in increasing gum tissue without major problems.
Past research has found both partial and full-thickness methods safe. However, using bone screws in the full-thickness method is a newer approach, and specific safety data for this is limited. The FDA has approved bone screws, providing some assurance of their safety.
In summary, FGGs are generally well-tolerated and safe, but the new technique using bone screws is still under evaluation for safety.12345Why are researchers excited about this trial?
Researchers are excited about these treatments for keratinization deficiency because they explore innovative techniques in gingival grafting. Unlike traditional methods, the trial examines both partial-thickness and full-thickness bed preparations for grafts. The full-thickness approach is particularly intriguing due to the use of bone screws to anchor the sutures, which could potentially improve graft stability and integration. By comparing these methods, researchers aim to determine the most effective technique for enhancing gum tissue health and resilience, promising better outcomes for patients with keratinization deficiency.
What evidence suggests that this trial's techniques could be effective for increasing keratinized gingival tissue?
Research has shown that free gingival grafts (FGG), used to widen gum tissue, yield good results with various preparation methods. In this trial, participants will undergo either a full-thickness bed preparation with bone screw placement or a partial-thickness bed preparation. Studies have found that both full-thickness and partial-thickness preparations of the graft site can lead to effective healing and stable grafts. One study comparing these methods found that FGG can change in size and thickness within three months after surgery, regardless of the method used. Healing studies also indicate that FGG can successfully blend with the surrounding tissue. Thus, whether using full-thickness with bone screws or partial-thickness methods, the grafts are likely to effectively increase the width of the gum tissue.13467
Who Is on the Research Team?
Tatakis Dimitris, DDS, PhD
Principal Investigator
The Ohio State University Graduate Periodontics Program Director
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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