Gingival Grafting Techniques for Gum Recession

Overseen By Sarah Startley, DMD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Smokers, Systemic pathologies, Active periodontal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Immediate procedure

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two gum grafting methods to improve tissue quality for individuals with gum recession. One method, Free Gingival Graft (FGG), uses the patient's own gum tissue. The other, Strip Free Gingival Graft (SGG) combined with Acellular Dermal Matrix Graft (ADM), uses a strip of the patient's gum with a special material called acellular dermal matrix. The researchers aim to determine which technique is more effective. This study may suit those with gum recession and teeth or implants lacking a specific type of protective tissue, who are patients at the UAB Dental School. As an unphased trial, it offers a unique opportunity to contribute to dental research and potentially enhance future treatment options for gum recession.

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 prior data suggests that these gingival grafting techniques are safe for treating gum recession?

A previous study compared two treatments for repairing gum tissue: acellular dermal matrix (ADM) and free gingival graft (FGG). Both treatments showed promise in improving gum health. ADM, a ready-to-use material, aids in repairing damaged tissue and has been found safe for gum issues.

Research has shown that the free gingival graft is a well-known method with a strong safety record, often used to increase healthy gum tissue.

Both treatments are generally well-tolerated, but like any medical procedure, side effects can occur. These might include temporary pain or swelling at the graft site. It is important to discuss potential risks with a healthcare provider before deciding to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these gingival grafting techniques for gum recession because they offer innovative approaches to improve gum health. The Strip Free Gingival Graft (SGG) combined with Acellular Dermal Matrix (ADM) provides a unique two-layer protection by using a thin strip from the patient's palate along with a rehydrated matrix, potentially enhancing tissue integration and stability. This method contrasts with the traditional Free Gingival Graft, which uses a thicker section from the palate and focuses on creating a stable, immobile bed for the graft. The dual-layer approach of SGG + ADM could lead to better outcomes in terms of graft stability and patient comfort, making it a promising alternative to standard techniques.

What evidence suggests that these gingival grafting techniques are effective for gum recession?

Research has shown that both Free Gingival Grafts (FGG) and Strip Gingival Graft with Acellular Dermal Matrix (SGG+ADM) are being studied in this trial to effectively treat gum recession. Participants in one arm of the trial will receive FGG, a reliable method to improve gum health and appearance by thickening gum tissue to prevent further recession. Meanwhile, participants in another arm will receive the combination of SGG and ADM, which also shows promise for achieving good aesthetic results and enhancing tissue quality. Both techniques aim to increase the amount of firm, protective gum tissue, which is important for healthy gums. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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

English speaking

My gums do not have enough protective tissue around my teeth or implants.

Able to read and understand informed consent document

Exclusion Criteria

I have had soft tissue grafting at the treatment site.

I have active gum disease.

I am under 18 years old.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Free Gingival Graft
• Strip Free Gingival Graft (SGG) + Acellular Dermal Matrix Graft (ADM)

Trial Overview

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).

How Is the Trial Designed?

Group I: Strip Free gingival graft (SGG) + Acellular Dermal Matrix graft (ADM) Experimental Treatment 1 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 Control 1 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

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

After 15 years, both acellular dermal matrix (ADM) allograft and autogenous free gingival graft (FGG) significantly increased keratinized tissue width and thickness, but FGG showed superior results in these areas.

The ADM group experienced a significant increase in recession depth and a high rate of tissue contraction (59.6%), while the FGG group had a decrease in recession depth and a lower contraction rate (17.6%), indicating better long-term stability with FGG.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Free gingival graft and acellular dermal matrix for gingival augmentation: a 15-year clinical study. Cevallos, CAR., de Resende, DRB., Damante, CA., et al.[2020]

In a clinical trial involving 9 subjects with bilateral gingival recession, both acellular dermal matrix allograft (ADMA) and subepithelial connective tissue graft (SCTG) showed improvements in clinical outcomes, but ADMA resulted in significantly lower root coverage (64.44%) compared to SCTG (82.01%).

Patients reported less pain with the ADMA treatment, suggesting it may be a more comfortable option for managing gingival recession, despite its lower effectiveness in root coverage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of acellular dermal matrix allograft (ADMA) and a subepithelial connective tissue graft (SCTG) for the treatment of gingival recession. Jenabian, N., Yazdanpanahbahabadi, M., Haghpanah Aski, P., et al.[2022]

A systematic review of 17 controlled trials found that acellular dermal matrix grafts (ADMG) provide similar root coverage and clinical attachment level gains as the gold standard subepithelial connective tissue grafts (SCTG) for treating gingival recession.

ADMG was found to be superior to SCTG in increasing the width of keratinized tissue, making it a suitable alternative for patients who prefer to avoid a second surgical site.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acellular dermal matrix and subepithelial connective tissue grafts for root coverage: A systematic review. Gallagher, SI., Matthews, DC.[2022]

The histological analysis of freeze-dried acellular dermal matrix (ADM) grafts revealed that the resulting tissue resembled scar tissue, indicating that ADM may not effectively promote normal tissue regeneration compared to autogenous free gingival grafts (FGG).

In contrast, FGG-derived tissue showed a more uniform epithelial structure and better-defined borders with surrounding tissues, suggesting that the microenvironment around the graft site plays a crucial role in epithelial differentiation and healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acellular dermal matrix allografts to achieve increased attached gingiva. Part 2. A histological comparative study. Wei, PC., Laurell, L., Lingen, MW., et al.[2022]

This study will compare the long-term effects of acellular dermal matrix grafts (ADMG) and connective tissue grafts (CTG) combined with coronally advanced flap (CAF) in treating gingival recession in 40 participants, assessing outcomes over 24 months.

The aim is to evaluate root coverage, aesthetics, and patient satisfaction, addressing the potential advantages of using ADMG, which may reduce complications associated with harvesting autogenous tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Zhan, Y., Wang, M., Cao, X., et al.[2022]

In a study involving 32 bilateral Miller Class I or II gingival recessions, a modified surgical technique using acellular dermal matrix grafts (ADMG) showed a statistically significant greater reduction in gingival recession compared to the conventional technique.

The modified technique resulted in a higher percentage of root coverage (79%) compared to the traditional method (63.9%), indicating it may be more effective for root coverage procedures in periodontal surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 6-month comparative clinical study of a conventional and a new surgical approach for root coverage with acellular dermal matrix. Barros, RR., Novaes, AB., Grisi, MF., et al.[2022]

In a study involving 16 patients with bilateral gingival recessions, the use of Acellular Dermal Matrix (ADM) allograft for root coverage showed similar effectiveness to traditional connective tissue grafts (CTG) in reducing recession and improving clinical attachment after 6 months.

While both techniques were effective, the CTG group experienced a significant increase in the width of keratinized tissue compared to the ADM group, suggesting that while ADM is a viable alternative, it may not provide the same benefits in tissue width.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Gholami, GA., Saberi, A., Kadkhodazadeh, M., et al.[2022]

In a clinical trial involving 39 patients with gingival recessions, both acellular dermal matrix allograft (ADMA) and autogenous connective tissue graft (CTG) showed significant improvements in clinical parameters over 5 years, with CTG demonstrating a greater gain in keratinized mucosa width.

ADMA presents a viable alternative for treating gingival recessions, with only one minor complication reported, while CTG may be preferred if increasing keratinized mucosa width is a primary goal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acellular dermal matrix allograft versus autogenous connective tissue grafts for thickening soft tissue and covering multiple gingival recessions: a 5-year preference clinical study. Kroiss, S., Rathe, F., Sader, R., et al.[2021]

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