Gingival Grafting Techniques for Gum Recession
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Alabama at Birmingham
Disqualifiers: Smokers, Systemic pathologies, Active periodontal, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial compares two methods to improve gum tissue quality in patients who lack Keratinized Tissue (KT). One method uses a piece of the patient's own gum tissue, while the other combines a small strip of gum tissue with a special growth-promoting material. The study aims to see which method is better for increasing tissue thickness, improving aesthetics, and minimizing patient discomfort.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of this treatment for gum recession?
Research shows that using acellular dermal matrix (ADM) grafts can be effective for treating gum recession, similar to traditional methods like connective tissue grafts. ADM grafts are beneficial because they reduce the need for tissue from the patient's own mouth, which can lessen discomfort and complications.
12345Is gingival grafting safe for treating gum recession?
Gingival grafting techniques, including the use of acellular dermal matrix (ADM) and autogenous free gingival grafts (FGG), have been studied for safety. These procedures are generally considered safe, but they can cause some discomfort and bleeding at the donor site. ADM is often used to reduce these issues, as it avoids the need to harvest tissue from the patient's own mouth.
12467How does the treatment for gum recession using Free Gingival Graft, Strip Free Gingival Graft + Acellular Dermal Matrix Graft differ from other treatments?
This treatment is unique because it combines a patient's own tissue (autogenous graft) with an acellular dermal matrix (ADM), which is a substitute material that reduces the need for tissue from another part of the patient's mouth, potentially decreasing pain and recovery time. The ADM provides a scaffold for tissue regeneration without the complications associated with harvesting tissue from the patient.
12468Eligibility Criteria
This trial is for patients at the UAB Dental School, over 18 years old, who can understand consent forms and speak English. They should have healthy teeth or implants next to areas lacking keratinized tissue but no active gum disease, previous grafts in those areas, systemic conditions affecting healing, or heavy tobacco use.Inclusion Criteria
I am 18 years old or older.
English speaking
My gums do not have enough protective tissue around my teeth or implants.
+3 more
Exclusion Criteria
I have had soft tissue grafting at the treatment site.
I have active gum disease.
I do not speak English.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo soft tissue grafting using either Free Gingival Graft (FGG) or Strip Gingival Graft with Acellular Dermal Matrix (SGG+ADM)
Immediate procedure
1 visit (in-person)
Follow-up
Participants are monitored for changes in soft tissue quality and quantity, as well as patient-centered outcomes
12 months
Multiple visits (in-person)
Participant Groups
The study compares two methods of increasing keratinized tissue around teeth and implants: one using a patient's own gum tissue (Free Gingival Graft) and another combining this with an Acellular Dermal Matrix (Strip Gingival Graft + ADM).
2Treatment groups
Experimental Treatment
Active Control
Group I: Strip Free gingival graft (SGG) + Acellular Dermal Matrix graft (ADM)Experimental Treatment1 Intervention
A horizontal incision is then placed at the middle of residual KT. Two vertical releasing incisions are followed to allow for apical displacement of the flap. The recipient site should ideally retain intact periosteum that is firmly attached to bone with no loose fibers, no irregularities and no perforations.
A strip of a free gingival graft is then harvested from the patient's palate. This strip is only 2 to 3 mm wide ,1 to 1.5 mm thick and has an appropriate length to cover the full apical extension of the recipient site. The strip is sutured immediately with 6-0 monocryl sutures. Coronal to the strip, the periosteal bed is covered with ADM, which is already rehydrated in sterile saline for 10 min, trimmed and customized to fit the available space. The ADM is then stabilized on the periosteal bed with the epithelium side facing upward. The ADM is fixed on the recipient bed by periosteal 6-0 monocryl sutures.
Group II: Free gingival graft.Active Control1 Intervention
Two vertical incisions are made, and a partial thickness flap are designed to provide a firm and immobile periosteal bed. The raised partial thickness flap will be excised. Muscle and unattached connective tissue fibers are thoroughly scraped with a scalpel to prevent graft mobility. Autogenous FGG was harvested with #15C scalpel blade from hard palate at the same side randomly selected to receive the FGG. Donor area will be sutured with 5-0 gut sutures. FGG, is placed and stabilized with simple interrupted 5-0 vicryl sutures at recipient site coronal border and horizontal or periosteal anchorage sutures over the graft.
Free Gingival Graft is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Free Gingival Graft for:
- Gingival recession
- Periodontal defects
- Soft tissue augmentation around dental implants
🇪🇺 Approved in European Union as Free Gingival Graft for:
- Gingival recession
- Periodontal defects
- Soft tissue augmentation around dental implants
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Unversity of Alabama at Birmingham, School of DentistryBirmingham, AL
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Who Is Running the Clinical Trial?
University of Alabama at BirminghamLead Sponsor
References
Acellular dermal matrix and subepithelial connective tissue grafts for root coverage: A systematic review. [2022]The aim of this systematic review was to evaluate whether patients with gingival recession would benefit from an acellular dermal matrix graft (ADMG) in ways that are comparable to the gold standard of the subepithelial connective tissue graft (SCTG).
Comparison of the clinical outcomes of connective tissue and acellular dermal matrix in combination with double papillary flap for root coverage: A 6-month trial. [2022]Different techniques have been proposed for the treatment of gingival recession. The majority of current procedures use autogenous soft-tissue grafts, which are associated with morbidity at the donor sites. Acellular dermal matrix (ADM) Alloderm is an alternative donor material presented to reduce related morbidity and provide more volume of the donor tissue. This study aimed to evaluate the effectiveness of an ADM allograft for root coverage and to compare it with a connective tissue graft (CTG), when used with a double papillary flap.
Acellular dermal matrix allograft versus autogenous connective tissue grafts for thickening soft tissue and covering multiple gingival recessions: a 5-year preference clinical study. [2021]The present preference clinical trial compared the long-term outcome of acellular dermal matrix allograft (ADMA) versus autogenous connective tissue graft (CTG) in the treatment of gingival recessions.
Free gingival graft and acellular dermal matrix for gingival augmentation: a 15-year clinical study. [2020]This study evaluated clinical outcomes of acellular dermal matrix (ADM) allograft compared with autogenous free gingival graft (FGG) for gingival augmentation after 15 years.
Acellular dermal matrix allografts to achieve increased attached gingiva. Part 2. A histological comparative study. [2022]In part 1 of this study, we compared the clinical efficacy of freeze-dried acellular dermal matrix (ADM) allograft in 6 patients with autogenous free gingival graft (FGG) in 6 patients for increasing the width of attached gingiva in the mandibular anterior area. The purpose of the present study was to histologically compare the microstructure of ADM and FGG treated sites from the same group.
Effectiveness of acellular dermal matrix graft with a coronally advanced flap for the treatment of Miller Class I/II single gingival recession with thin gingival phenotype: study protocol for a split-mouth randomised controlled trial. [2022]Gingival recession is one of the most common mucogingival deformities requiring surgical correction. The American Academy of Periodontology Regeneration Workshop recommended connective tissue graft (CTG) combined with coronally advanced flap (CAF) for the treatment of Miller Class I and II single-tooth gingival recession. The disadvantages of harvesting autogenous tissue include postoperative bleeding, pain and discomfort at the donor site, restricted tissue supply, increased morbidity and prolonged operative times. Acellular dermal matrix (ADM) contains undamaged collagen and elastin matrices that can be used as a substitute for CTG during root coverage procedures. However, the use of ADM is still controversial. The objective of this split-mouth; randomised, controlled, clinical study is to evaluate the long-term effects of ADM graft (ADMG) combined with CAF on root coverage, aesthetics and patient satisfaction for the treatment of single gingival recession with thin gingival phenotype.
Comparison of acellular dermal matrix allograft (ADMA) and a subepithelial connective tissue graft (SCTG) for the treatment of gingival recession. [2022]This study aimed to evaluate the effect of acellular dermal matrix allograft (ADMA) for the treatment of gingival recession as a substitute for subepithelial connective tissue graft (SCTG).
A 6-month comparative clinical study of a conventional and a new surgical approach for root coverage with acellular dermal matrix. [2022]The acellular dermal matrix graft (ADMG) has become widely used in periodontal surgeries as a substitute for the subepithelial connective tissue graft (SCTG). These grafts exhibit different healing processes due to their distinct cellular and vascular structures. Therefore the surgical technique primarily developed for the autograft may not be adequate for the allograft. This study compared the clinical results of two surgical techniques--the "conventional" and a modified procedure--for the treatment of localized gingival recessions with the ADMG.