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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a treatment for gum recession using an acellular dermal matrix, a grafting material made from human tissue. Researchers aim to assess the treatment's effectiveness for individuals with varying gum thicknesses, specifically those with thin and thick gum tissue. They will observe participants at several points over four years to evaluate the treatment's success. This trial suits patients with specific types of gum recession who are already receiving treatment at Tufts University School of Dental Medicine and do not have conditions affecting healing. As a Phase 4 trial, this research involves an FDA-approved treatment, helping to understand its benefits for more patients.

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 is the safety track record for Acellular Dermal Matrix?

Research has shown that acellular dermal matrix (ADM) is generally safe for people. ADM, made from human or animal tissue, integrates well with the body. In one study, 15 patients with 53 areas of gum recession received ADM treatment, which proved effective. Another study demonstrated that out of 20 gum areas treated with ADM, seven achieved complete root coverage, with an average coverage of over 73%.

These studies reported no major safety issues, indicating that ADM is well-tolerated. As this treatment is in a later phase, it has already passed earlier safety tests and is deemed safe enough for further research. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Acellular Dermal Matrix (ADM) for gum recession because it offers a new approach compared to traditional treatments like connective tissue grafts. Unlike those methods, ADM uses processed human tissue to support the healing of gum tissue, potentially reducing the need for tissue harvesting from the patient's palate. This could result in less discomfort and recovery time for patients. Additionally, ADM might improve outcomes by providing a stable framework for gum regeneration, which is especially promising for patients with varying gum thicknesses.

What is the effectiveness track record for Acellular Dermal Matrix in treating gum recession?

Research has shown that acellular dermal matrix (ADM) effectively treats receding gums. In this trial, participants will be divided into two groups based on gingival thickness: Group 1 with a thin biotype and Group 2 with a thick biotype. Studies have found that ADM not only improves appearance but also reduces tooth sensitivity, a common issue with receding gums. In some cases, ADM performs as well as connective tissue grafts, often considered the best treatment for this condition. Patients have reported positive outcomes, such as reduced discomfort after surgery and improved appearance. This treatment has been used successfully for years, consistently covering exposed roots and enhancing gum health. ^{6 7 8 9 10}

Who Is on the Research Team?

Wai Cheung, DMD, MS

Principal Investigator

Tufts University School of Dental Medicine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8796220/

Effectiveness of acellular dermal matrix graft with a coronally ... This trial will compare the long‐term outcomes of acellular dermal matrix graft and connective tissue graft for treating gingival recessions ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38409621/

Efficacy of acellular xenogeneic dermal matrix graft in the ... Conclusions: CTG is more effective than AXDM in treating multiple gingival recessions. This is evidenced by significant reductions in gingival ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0901502719314389

Clinical efficacy of acellular dermal matrix for plastic ... Concerning patient-reported outcomes, ADM achieved favourable aesthetic appearance, alleviation of dentinal hypersensitivity, and less surgical morbidity. In ...

4. apm.amegroups.org apm.amegroups.org/article/view/98157/html

Efficacy and safety of acellular dermal matrix versus ... These findings suggest that patients with gingival recession may experience a benefit from the ADM treatment that is comparable to the CTG as the gold standard, ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03043638?tab=table

Efficiency of PRP on Acellular Dermal Matrix Application in ... The aim of this study was to evaluate the effectiveness of platelet rich plasma (PRP) combined with coronally advanced flap plus acellular dermal matrix ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35927781/

Efficacy and safety of acellular dermal matrix versus ... The ADM treatment for patients with gingival recession may be superior to CTG in gaining CAL, but CTG has a significant advantage over ADM for gaining KT width.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9327458/

Comparison of acellular dermal matrix allograft (ADMA) ... In more than 50% of people, one or more gingival recessions with <1 mm height have been observed. The gingival recession might cause an increase in tooth ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1013905219311861

Long-term predictability of allogenic dermal matrix for root ... 15 patients with total of 53 recession defects have been treated with Acellular Dermal Matrix (ADM). The following clinical parameters were evaluated recession ...

9. withpower.com withpower.com/trial/phase-4-gingival-recession-7-2015-d1143

Acellular Dermal Matrix for Gum Recession 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 ...

10. journals.lww.com journals.lww.com/jpbs/fulltext/2016/08001/management_of_gingival_recession_with_acellular.15.aspx

Management of gingival recession with acellular dermal... Out of 20 sites treated with acellular dermal matrix graft, seven sites showed complete root coverage (100%), and the mean root coverage obtained was 73.39%.