Soft Tissue Augmentation for Implant Complications

Overseen By Lorenzo Tavelli, DDS, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Harvard Medical School (HMS and HSDM)

Disqualifiers: Diabetes, HIV, Cancer, Smoking, others

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

Compensation: Varies

Number of Visits: 3

Duration: 12 months

28 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two methods to address gum issues around dental implants. Researchers aim to determine which is more effective: using tissue from the patient's own mouth (Autogenous Connective Tissue Graft) or a special mix of lab-made materials (Acellular Dermal Matrix + Enamel Matrix Derivative). Candidates with a single dental implant in the front of the mouth and gum problems, who are otherwise healthy, may qualify. As an unphased trial, this study provides a unique opportunity to contribute to dental research and potentially enhance treatment options for gum issues around implants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the trial requires participants to be systemically healthy, it's possible that certain medications might need to be adjusted. Please consult with the trial coordinators for specific guidance.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using an acellular dermal matrix (ADM) with an enamel matrix derivative (EMD) is safe. ADM has been used for over ten years, and in more than 500 cases, no reports of viral transmission have occurred. This makes it a safe alternative to using a patient's own tissue. Studies also indicate that ADM can effectively increase the thickness of soft tissue around implants, which supports its safety and effectiveness.

In contrast, the autogenous connective tissue graft uses tissue from the patient's own body. This common practice in dental procedures is generally well-tolerated. Since the tissue comes from the patient's own body, the risk of rejection remains low.

Both treatments have strong safety records, providing reassurance about their safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for soft tissue augmentation in implant complications because they offer unique approaches compared to traditional methods. The combination of acellular dermal matrix and enamel matrix derivative is notable for providing a scaffold that supports tissue regeneration while minimizing the need for harvesting tissue from the patient, potentially reducing recovery time and discomfort. On the other hand, the autogenous connective tissue graft, though a more traditional method, is enhanced by being de-epithelialized, which could improve integration and healing. These innovations could lead to better outcomes and greater patient satisfaction.

What evidence suggests that this trial's treatments could be effective for soft tissue augmentation?

This trial will compare two methods for soft tissue augmentation around dental implants. One method uses a combination of Acellular Dermal Matrix and Enamel Matrix Derivative (ADM + EMD). Studies have shown that this combination effectively supports tissue regrowth, with patients demonstrating better soft tissue coverage and healing.

The other method, part of a separate treatment arm in this trial, uses autogenous connective tissue grafts. Research has found this approach effective for covering areas with missing tissue at implant sites, as it uses the patient's own tissue, which the body typically accepts well, aiding in healing. Both treatments in this trial have shown promise in improving soft tissue coverage and regrowth around dental implants. ^{1 3 4 5 6}

Who Is on the Research Team?

Lorenzo Tavelli, DDS, MS

Principal Investigator

Harvard School of Dental Medicine, Boston, USA

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a single functional dental implant in the front of their mouth that needs more gum tissue. They must have good oral hygiene and overall health, with no untreated gum disease around the implant. Smokers or those with certain systemic conditions like diabetes or cancer are excluded.

Inclusion Criteria

Full-mouth plaque score and full-mouth bleeding score ≤ 20% (measured at four sites per tooth)

I have healthy gums and no serious health issues.

Implants diagnosed as healthy (Berglundh et al., 2018)

Exclusion Criteria

Patients pregnant or attempting to get pregnant (self-reported)

I have untreated gum disease around my dental implant.

I have untreated gum disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either autogenous connective tissue graft or acellular dermal matrix with enamel matrix derivative for vertical soft tissue augmentation

12 months

Regular visits for treatment and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 3, 6, and 12 months

12 months

3 visits (in-person) at 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Acellular Dermal Matrix + Enamel Matrix Derivative
• Autogenous Connective Tissue Graft

Trial Overview The study compares two methods for adding gum tissue to dental implants where there's not enough: using the patient's own tissue (CTG) versus a combination of donor skin matrix (ADM) and enamel matrix derivative.

How Is the Trial Designed?

Group I: Dermal matrix + EMD Experimental Treatment 1 Intervention

Acellular dermal matrix and enamel matrix derivative

Group II: Connective tissue graft Active Control 1 Intervention

Autogenous connective tissue graft harvested from the palate as a free gingival graft and then de-epithelialized

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

Approved in European Union as AlloGraft Dermal Matrix + Emdogain for:

• Gingival recession
• Soft tissue augmentation at implant sites

Approved in United States as AlloGraft Dermal Matrix + Emdogain for:

• Gingival recession
• Soft tissue augmentation at implant sites

Who Is Running the Clinical Trial?

Harvard Medical School (HMS and HSDM)

Lead Sponsor

Trials

208

Recruited

1,421,000+

Published Research Related to This Trial

Allogenous dermal matrix (ADM) is a promising alternative to subepithelial connective tissue graft (SCTG) for promoting periodontal phenotype modification (PPM), especially in cases where autogenous grafts cannot be used.

ADM not only aids in soft tissue augmentation but also serves as a barrier membrane for hard tissue procedures, making it particularly beneficial for patients undergoing orthodontic treatment to enhance root coverage and prevent clinical attachment loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Periodontal phenotype modification of complexes periodontal-orthodontic case scenarios: A clinical review on the applications of allogenous dermal matrix as an alternative to subepithelial connective tissue graft. Chambrone, L., Garcia-Valenzuela, FS.[2023]

Longer surgical procedures and smoking significantly increase the risk of postoperative complications such as pain and swelling after soft tissue grafting, with smokers being three times more likely to experience swelling.

Free soft tissue grafting (FSTG) procedures are associated with a higher likelihood of postoperative pain and bleeding compared to subepithelial connective tissue grafting (SCTG), while using an acellular dermal matrix (ADM) instead of autogenous tissue significantly reduces the chances of swelling and bleeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative complications following gingival augmentation procedures. Griffin, TJ., Cheung, WS., Zavras, AI., et al.[2022]

In a study involving 12 patients with multiple gingival recessions, the enamel matrix derivative (EMD) used with a coronally advanced flap (CAF) showed similar effectiveness to a connective tissue graft (CTG) with CAF in reducing buccal recession depth after 6 months.

Both treatment methods resulted in comparable clinical outcomes for recession depth and probing pocket depth, but the CTG group had a significantly greater width of keratinized gingiva compared to the EMD group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of enamel matrix derivative (Emdogain) and subepithelial connective tissue graft for root coverage in patients with multiple gingival recession defects: A randomized controlled clinical study. Alexiou, A., Vouros, I., Menexes, G., et al.[2021]

The study found that using an enamel matrix derivative (EMD) along with a subepithelial connective tissue graft (CTG) and a coronally advanced flap (CAF) significantly improved periodontal healing in dogs, showing better reduction in probing pocket depth and greater clinical attachment gain compared to CTG alone.

Histological evaluations revealed that the EMD group had shorter epithelial lengths and greater cementum formation, indicating enhanced periodontal regeneration, which supports the clinical relevance of using EMD in treating gingival recession defects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Split-mouth evaluation of connective tissue graft with or without enamel matrix derivative for the treatment of isolated gingival recession defects in dogs. Shirakata, Y., Nakamura, T., Shinohara, Y., et al.[2020]

Acellular dermal matrix allograft (ADMA) can effectively augment keratinized tissue and cover soft tissue dehiscence around dental implants, addressing a common complication that can affect implant success.

In a specific case, the use of ADMA resulted in complete coverage of the implant surface, demonstrating its potential for improving esthetics and long-term outcomes in dental implant procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Soft tissue dehiscence coverage around dental implants following an acellular dermal matrix allograft: a case report. Ayobianmarkazi, N.[2014]

Acellular Dermal Matrix (ADM) grafts can effectively replace autogenous connective tissue grafts in oral hard tissue augmentation, reducing complications like donor site morbidity and the need for multiple surgeries.

Using ADM for soft tissue reconstruction prior to bone grafting can significantly lower the risk of graft exposure and failure, enhancing the overall success of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acellular dermal matrix in soft tissue reconstruction prior to bone grafting. A case report. Ruiz-Magaz, V., Hernández-Alfaro, F., Díaz-Carandell, A., et al.[2019]

A systematic review of 8 randomized controlled trials involving 306 patients found that xenogeneic collagen matrices (XCM) are less effective than subepithelial connective tissue grafts (CTG) for increasing soft tissue thickness around dental implants.

Despite being less effective than CTG, XCM still provides a significant gain in soft tissue thickness and can be recommended as an alternative in various clinical situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative analysis of xenogeneic collagen matrix and autogenous subepithelial connective tissue graft to increase soft tissue volume around dental implants: a systematic review and meta-analysis. Ashurko, I., Tarasenko, S., Magdalyanova, M., et al.[2023]

In a study of 41 patients over 3 years, the combination of subepithelial connective tissue graft (CTG) with enamel matrix derivative (EMD) significantly improved root coverage and increased keratinized tissue width compared to CTG alone.

Patients receiving the CTG-EMD treatment reported significantly less pain in the days following surgery, indicating a better patient-centered outcome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subepithelial connective tissue graft with or without enamel matrix derivative for the treatment of multiple Class III-IV recessions in lower anterior teeth: A 3-year randomized clinical trial. Mercado, F., Hamlet, S., Ivanovski, S.[2020]

In a systematic review of nine clinical studies, the combination of connective tissue graft (CTG) with enamel matrix derivative (EMD) showed a significant improvement in clinical attachment level gain (0.78 mm) and recession depth reduction (0.28 mm) compared to CTG alone.

While both methods achieved similar rates of complete root coverage, adding EMD to CTG may enhance specific outcomes related to gum health, suggesting a potential benefit in periodontal procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Connective Tissue Graft with or without Enamel Matrix Derivative for Treating Gingival Recession Defects: A Systematic Review and Meta-Analysis. Dubey, P., Narasimhan, M., Sehgal, NK., et al.[2022]

In a study of 80 patients over 3 years, the addition of enamel matrix derivative (EMD) to subepithelial connective tissue grafts (CTG) significantly improved root coverage and keratinized tissue width in treating periodontal recession defects compared to CTG alone.

Patients receiving EMD reported significantly less pain two weeks post-surgery, indicating that EMD not only enhances clinical outcomes but also improves patient comfort during recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 3-year prospective clinical and patient-centered trial on subepithelial connective tissue graft with or without enamel matrix derivative in Class I-II Miller recessions. Mercado, F., Hamlet, S., Ivanovski, S.[2020]

In a study involving 20 patients with gum recession, the use of enamel matrix derivative (EMD) under a coronally advanced flap showed similar root coverage effectiveness compared to the traditional subepithelial connective tissue graft, achieving an average root coverage of about 94%.

The EMD treatment resulted in better early healing and less patient-reported discomfort compared to the connective tissue graft, suggesting it may be a less invasive option with comparable efficacy for treating recession defects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of human recession defects treated with coronally advanced flaps and either enamel matrix derivative or connective tissue. Part 1: Comparison of clinical parameters. McGuire, MK., Nunn, M.[2015]

Acellular dermal matrices (ADM) like NovoMatrix (NM) and mucoderm (MD) showed superior maximum load (ML) compared to autogenous soft tissue grafts (ASG), indicating that ADMs may provide better structural support in clinical applications.

The study revealed significant differences in the biomechanical properties and architectural features of ASG and ADM, which can help inform their clinical use and effectiveness in soft tissue grafting procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomechanical Characterization of a New Acellular Dermal Matrix for Oral Soft Tissue Regeneration. Pabst, A., Sagheb, K., Blatt, S., et al.[2022]

Citations

1. journalimplantdent.springeropen.com journalimplantdent.springeropen.com/articles/10.1186/s40729-025-00635-5

Evaluation of enamel matrix derivative used alone or added to ... In addition to the matrices, enamel matrix derivatives (EMDs, amelogenins) have been found to promote soft tissue regeneration. Amelogenins ...

2. sciencedirect.com sciencedirect.com/topics/medicine-and-dentistry/acellular-dermal-matrix

Acellular Dermal Matrix - an overview Acellular dermal matrix is an allograft tissue that is chemically processed to remove all epidermal and dermal cells while preserving the remaining bioactive ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/prd.12633?af=R

Impact of soft tissue augmentation procedures on esthetics ... The aim of this systematic review was to assess the performance of soft tissue augmentation (STA) procedures, with or without a modification ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8005981/

Regenerative Potential of Enamel Matrix Protein Derivative ... The purpose of this study was to assess the clinical effectiveness of using a combination of enamel matrix protein derivative and acellular dermal matrix

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12545986/

Evaluation of enamel matrix derivative used alone or ... In addition to the matrices, enamel matrix derivatives (EMDs, amelogenins) have been found to promote soft tissue regeneration. Amelogenins ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37141080/

Effect of Acellular Dermal Matrix Placement Simultaneous ... ADM membrane can be successfully used to augment vertical soft tissue thickness simultaneous with implant placement.