Gingival Grafting Techniques for Gum Recession
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: University of Alabama at Birmingham
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.
Is the treatment 'Free Gingival Graft, Strip Free Gingival Graft (SGG) + Acellular Dermal Matrix Graft (ADM)' a promising treatment for gum recession?Yes, the treatment using Free Gingival Graft combined with Acellular Dermal Matrix Graft (ADM) is promising for gum recession. ADM can reduce pain and discomfort because it avoids taking tissue from another part of the mouth. It also provides enough tissue for the procedure and has been shown to be effective in covering exposed roots and improving the appearance of gums.23467
What safety data exists for gingival grafting techniques for gum recession?The safety data for gingival grafting techniques, including Free Gingival Graft (FGG) and Acellular Dermal Matrix Graft (ADM), is supported by several studies. A 15-year clinical study compared ADM allografts with autogenous FGG for gingival augmentation, indicating long-term clinical outcomes. A systematic review evaluated ADM grafts for root coverage, comparing them to the gold standard subepithelial connective tissue grafts (SCTG). Another study compared ADM with connective tissue grafts, highlighting ADM as an alternative to reduce donor site morbidity. A split-mouth randomized controlled trial protocol aimed to assess ADM combined with a coronally advanced flap for treating gingival recession, addressing concerns about ADM's use. Overall, these studies suggest ADM as a viable alternative with potential benefits in reducing donor site morbidity and providing effective gingival recession treatment.34678
What data supports the idea that Gingival Grafting Techniques for Gum Recession is an effective treatment?The available research shows that Gingival Grafting Techniques, such as using an acellular dermal matrix (ADM) or a free gingival graft (FGG), are effective for treating gum recession. Studies have compared ADM with other methods like connective tissue grafts (CTG) and found that ADM can be just as effective for covering exposed roots and increasing gum tissue. For example, a 15-year study showed positive outcomes for both ADM and FGG in increasing gum tissue. Additionally, ADM is noted for causing less discomfort at the donor site compared to traditional methods, making it a preferable option for some patients.13456
Do I need to stop taking my current medications for the trial?The trial protocol does not specify whether you need to stop taking your current medications. However, if you have systemic conditions that contraindicate oral surgery or affect wound healing, you may not be eligible to participate.
Eligibility 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.
My gums do not have enough protective tissue around my teeth or implants.
My teeth next to the treatment area are healthy, or I have healthy implants or gums.
Exclusion Criteria
I have had soft tissue grafting at the treatment site.
I have active gum disease.
I do not speak English.
I am under 18 years old.
I do not have any health conditions that would interfere with surgery or healing.
Treatment Details
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 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.
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.
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 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).
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.
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).