Acellular Dermal Matrix for Gum Recession

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Tufts University

Must not be taking: Immunosuppressants

Disqualifiers: Pregnancy, Immunosuppression, Smoking, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: Immediate post-surgery

34 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are taking immunosuppressant medications, you would not be eligible to participate.

What data supports the effectiveness of the treatment Acellular Dermal Matrix for gum recession?

Research shows that Acellular Dermal Matrix (ADM) is effective in treating gum recession, with studies highlighting patient satisfaction and positive long-term outcomes in covering exposed roots. ADM has been compared favorably to other methods, such as connective tissue grafts, for improving gum health. ^{1 2 3 4 5}

Is acellular dermal matrix safe for use in humans?

Acellular dermal matrix (ADM) is generally considered safe for use in humans, as it is a biocompatible material derived from human and animal tissue. It has been used successfully in various surgical procedures, including dental surgeries, without significant safety concerns reported in the studies. ^{2 3 4 6 7}

How is the treatment Acellular Dermal Matrix (ADM) unique for gum recession?

Acellular Dermal Matrix (ADM) is unique because it uses a biocompatible material derived from human and animal tissue that promotes natural healing by encouraging blood vessel growth and tissue remodeling. Unlike other treatments, ADM does not require harvesting tissue from the patient's own mouth, making it less invasive and potentially more comfortable. ^{1 3 4 6 8}

What is the purpose of this trial?

Gingival recession is a common defect among the American population. It is also a major cause for root decay, hypersensitivity, contributes to tooth mobility and low self-esteem. Acellular dermal matrix, a human-derived grafting material has been put on the market for the treatment of gingival recession. Treating gingival recession with this material has been a validated treatment option for years. However, treatment outcomes in two patient populations, namely those with thin biotypes and those with thick biotypes, has not been investigated. This study will observe the primary treatment outcomes in the two patient groups at 5 time points - 3 months, 6 months and 12 months post-surgery to observe short term outcomes; additional 24 months and 48 months post-surgery to observe long term outcomes.

Research Team

Wai Cheung, DMD, MS

Principal Investigator

Tufts University School of Dental Medicine

Eligibility Criteria

This trial is for current patients at Tufts University School of Dental Medicine with mild to moderate gum recession (2-4 mm) on certain front teeth. Participants should be generally healthy, have good oral hygiene (low plaque and gingival index), and not have any conditions that would prevent them from undergoing surgery for root coverage.

Inclusion Criteria

I have two adjacent gums receded between 2mm and less than 4mm.

I am healthy and can safely undergo surgery to cover exposed tooth roots.

My dental issue involves front teeth, except the bottom front ones.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Acellular Dermal Matrix (ADM) is applied beneath a coronally advanced flap during mucogingival surgery for both thin and thick gingival biotype groups

Immediate post-surgery

1 visit (in-person)

Short-term Follow-up

Participants are monitored for short-term outcomes at 3 and 6 months post-surgery

6 months

2 visits (in-person)

Long-term Follow-up

Participants are monitored for long-term outcomes at 12, 24, and 48 months post-surgery

48 months

3 visits (in-person)

Treatment Details

Interventions

• Acellular Dermal Matrix

Trial Overview The study tests the effectiveness of Acellular Dermal Matrix, a human-derived graft material, in treating gum recession over short-term (3, 6, 12 months) and long-term periods (24, 48 months). It focuses on comparing results between patients with thin and thick gums.

Participant Groups

Group I: Group 2: Thick Biotype Experimental Treatment 1 Intervention

Gingival thickness ≥ 0.8 mm Acellular Dermal Matrix (ADM) will be used according to manufacturer's instructions during mucogingival surgery. Subjects will be anesthetized using local anesthesia. An envelope flap design will be involved with no releasing incisions. The ADM will be placed beneath the flap. The flap will then be advanced to the level of cemento-enamel junction (CEJ). The area will be sutured. Mean root coverage, CPD, CAL, RH, RW, KTW, GT, and CRC will be measured and compared at 3 months, 6 months, 12 months, 24 months and 48 months post-surgery.

Group II: Group 1: Thin Biotype Experimental Treatment 1 Intervention

Gingival thickness \< 0.8 mm Acellular Dermal Matrix (ADM) will be used according to manufacturer's instructions during mucogingival surgery. Subjects will be anesthetized using local anesthesia. An envelope flap design will be involved with no releasing incisions. The ADM will be placed beneath the flap. The flap will then be advanced to the level of cemento-enamel junction (CEJ). The area will be sutured. Mean root coverage, CPD, CAL, RH, RW, KTW, GT, and CRC will be measured and compared at 3 months, 6 months, 12 months, 24 months and 48 months post-surgery.

Acellular Dermal Matrix is already approved in United States, European Union for the following indications:

Approved in United States as Acellular Dermal Matrix for:

• Soft tissue reinforcement
• Other non-breast related indications

Approved in European Union as Acellular Dermal Matrix for:

• Soft tissue reinforcement
• Other non-breast related indications

Who Is Running the Clinical Trial?

Tufts University

Lead Sponsor

Trials

271

Recruited

595,000+

Findings from Research

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]

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]

References

1. Israel pubmed.ncbi.nlm.nih.gov

[Using acellular dermal matrix (ADM) allograft in periodontal surgery--a literature review and case reports]. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

A patient-centered clinical evaluation of acellular dermal matrix graft in the treatment of gingival recession defects. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Acellular dermal matrix for root coverage procedures: 9-year assessment of treated isolated gingival recessions and their adjacent untreated sites. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

Root coverage with tunneling technique or modified advanced flap associated with acellular dermal matrix: results from 6 months randomized clinical trial. [2022]

5. Germany 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. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Treatment of Exposed Bone With Acellular Dermal Matrix in a Smoker Patient After Dental Implant Surgery: A Case Report. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

A comparative study of root coverage using acellular dermal matrix with and without enamel matrix derivative. [2007]

8. United States 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. [2022]