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?

The study aims at comparing two different approaches for vertical soft tissue augmentation at implant sites exhibiting soft tissue dehiscences: autogenous connective tissue graft vs acellular dermal matrix + enamel matrix derivative

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 the treatment using Acellular Dermal Matrix and Enamel Matrix Derivative safe for humans?

The studies reviewed focus on the effectiveness of treatments using enamel matrix derivative and connective tissue grafts for dental issues, but they do not provide specific safety data. However, these treatments are commonly used in dental procedures, suggesting they are generally considered safe. ^{1 2 3 4 5}

How is the treatment using Acellular Dermal Matrix and Enamel Matrix Derivative different from other treatments for implant complications?

This treatment is unique because it uses an Acellular Dermal Matrix (ADM) as a substitute for donor connective tissue, which avoids the complications and limitations of harvesting tissue from the patient's own body. ADM provides an unlimited supply of tissue, making it suitable for large defects, and it can improve the quality and quantity of soft tissue around dental implants, potentially reducing complications like wound dehiscence. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Acellular Dermal Matrix + Enamel Matrix Derivative for soft tissue augmentation in implant complications?

Research shows that using a connective tissue graft with enamel matrix derivative can improve outcomes in treating gum recession, suggesting potential benefits for similar soft tissue treatments. Additionally, allogenous dermal matrix has been reviewed as a promising alternative for modifying gum tissue in complex dental cases. ^{4 5 7 11 12}

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

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. United States 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. [2020]

2. Germany 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. [2020]

3. United States 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. [2020]

4. United States 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. [2022]

5. England 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. [2023]

6. United States 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. [2015]

7. Germany 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. [2021]

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

Biomechanical Characterization of a New Acellular Dermal Matrix for Oral Soft Tissue Regeneration. [2022]

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

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

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

Postoperative complications following gingival augmentation procedures. [2022]

11. England 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. [2023]

12. Spain pubmed.ncbi.nlm.nih.gov

Acellular dermal matrix in soft tissue reconstruction prior to bone grafting. A case report. [2019]