Collagen Matrix After Gum Grafting for Gum Recession

Overseen By Hailey Bivens, DDS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hailey Bivens

Must not be taking: Phenytoin, Cyclosporine, Dihydropyridines

Disqualifiers: Diabetes, Cancer, HIV, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding a collagen matrix (a thick sponge-like material) to the donor site after a gum graft aids healing and increases tissue thickness. It compares two groups: one using the collagen matrix and one not using it. The main focus is to determine if the collagen affects tissue healing and volume over time. Ideal participants are non-smokers who need a gum graft and have healthy gums with no prior palate surgeries. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future gum graft procedures.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes people who have taken medications affecting periodontal status or wound healing in the past 6 months. It's best to discuss your specific medications with the trial team.

What prior data suggests that this collagen matrix is safe for gum grafting?

Research has shown that using a collagen matrix for gum treatment is generally safe. In one study, 8 out of 10 patients experienced complete healing within two weeks, indicating that the collagen matrix is well-tolerated. Another study found that the treatment provided full gum coverage in 72% of cases over a year. This demonstrates its effectiveness and suggests safety, as no major issues were reported. Overall, evidence suggests that the collagen matrix is a safe option for treating gums. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for gum recession involve using tissue from the patient’s palate to graft onto the affected area. However, researchers are excited about the addition of a collagen matrix to this process. Unlike the standard grafting technique, which solely relies on the harvested tissue, the collagen matrix may enhance healing by providing an additional scaffold for new tissue growth. This could potentially lead to better outcomes, like quicker recovery and improved gum stability.

What evidence suggests that the collagen matrix is effective for gum recession?

Research has shown that collagen matrices can effectively treat gum recession. One study achieved complete gum coverage in 72% of cases, with an average coverage of 94.32%. Other studies have found that collagen matrices can significantly reduce gum recession when combined with certain surgical methods. In this trial, some participants will receive a collagen matrix after a subepithelial connective tissue graft, while others will not. Additionally, collagen matrices may help maintain the volume and thickness of treated areas. This suggests that using a collagen matrix after a gum graft can aid in tissue healing and stability. ^{2 6 7 8 9}

Who Is on the Research Team?

Ying S Wang, DDS, MS

Principal Investigator

Texas A&M School of Dentistry

Are You a Good Fit for This Trial?

This trial is for people aged 18-65 who have healthy gums but need a gum graft, are non-smokers, and haven't had palate surgery or orthodontic treatments involving palatal expansion. They must be in good physical and mental health without any conditions that would complicate periodontal surgery.

Inclusion Criteria

I haven't used tobacco or nicotine products in the last 5 years.

No history of cleft lip/palate

My gums are healthy.

Exclusion Criteria

I do not have active gum disease.

Smokers or users of nicotine replacement products

Drug or alcohol abuse history

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Assessment

Clinical assessment of palatal thickness and digital intraoral scan performed pre-operatively

1 week

1 visit (in-person)

Treatment

Subepithelial connective tissue graft harvested from the palate; participants randomly assigned to receive or not receive augmentation with a collagen matrix

1 week

1 visit (in-person)

Follow-up

Palatal thickness measurements and intraoral scans repeated to assess volumetric changes

6 months

3 visits (in-person) at 2, 4, and 6 months postoperatively

What Are the Treatments Tested in This Trial?

Interventions

• Collagen Matrix
• Subepithelial Connective Tissue Graft

Trial Overview The study tests if adding a collagen matrix to the donor site in the palate after a gum graft leads to changes in tissue thickness and volume. Participants will either receive this augmentation or not, randomly assigned, to compare outcomes between the two groups.

How Is the Trial Designed?

Group I: Collagen Matrix Experimental Treatment 1 Intervention

Individuals with the addition of the intervention (collagen matrix) after harvesting form the palate for a subepithelial connective tissue graft.

Group II: Control Active Control 1 Intervention

Individuals with no addition of intervention (collagen matrix) after harvesting from the palate for a subepithelial connective tissue graft.

Who Is Running the Clinical Trial?

Hailey Bivens

Lead Sponsor

Trials

1

Recruited

40+

Published Research Related to This Trial

A 3-year follow-up case study demonstrated that using a subepithelial connective tissue graft (SCTG) with the tunnel technique effectively treated multiple gingival recessions, achieving an average coverage of 74.2%.

The technique not only provided root coverage but also resulted in an increase in keratinized tissue and tissue thickness, indicating a successful long-term outcome for the patient's oral health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tunnel technique with a surgical maneuver to increase the graft extension: case report with a 3-year follow-up. Ribeiro, FS., Zandim, DL., Pontes, AE., et al.[2008]

In a study involving 12 patients with gingival recessions, the subepithelial connective tissue graft (SCTG) technique showed superior results compared to guided tissue regeneration (GTR) in reducing gingival recession height and increasing keratinized tissue width after 18 months.

While SCTG was better for gingival recession height and keratinized tissue, GTR provided a greater reduction in probing depth, indicating that both methods have their strengths, but the aesthetic outcomes were similarly satisfactory for both treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of gingival recession: comparative study between subepithelial connective tissue graft and guided tissue regeneration. Rosetti, EP., Marcantonio, RA., Rossa, C., et al.[2006]

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]

In a study involving 10 patients, two techniques for removing epithelium from subepithelial connective tissue grafts (SCTGs) were compared, but neither method showed a significant difference in the presence of epithelial remnants or tissue composition.

Both techniques resulted in similar histological outcomes, indicating that the choice between blade and abrasion methods does not affect the quality of SCTGs used for treating gingival recession.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of 2 techniques of epithelial removal in subepithelial connective tissue graft surgery: a comparative histological study. Marques de Mattos, P., Papalexiou, V., Tramontina, VA., et al.[2022]

Subepithelial connective tissue graft (SCTG) is highly effective for treating gingival recessions, as demonstrated in a case study of a 20-year-old woman with a 5 mm recession.

Histologic analysis after 11 months showed successful new attachment of connective tissue and collagen fibers to the tooth's dentin, indicating effective healing and integration of the graft.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Histologic and Clinical Study of Gingival Recession Treated with Subepithelial Connective Tissue Graft: A Case Report. García-De-la-Fuente, AM., Aguirre-Zorzano, LA., Estefanía-Fresco, R., et al.[2018]

In a study involving six beagle dogs with localized gingival recessions, all treatment methods (coronally advanced flap surgery with either a collagen matrix, a connective tissue graft, or alone) successfully covered the recessions without any complications, indicating safety in the procedures.

Histological analysis showed no significant advantage of using the collagen matrix or connective tissue graft over the coronally advanced flap surgery alone, suggesting that CAF alone is an effective treatment for localized Miller Class I recessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healing of localized gingival recessions treated with coronally advanced flap alone or combined with either a resorbable collagen matrix or subepithelial connective tissue graft. A preclinical study. Sculean, A., Mihatovic, I., Shirakata, Y., et al.[2021]

The subepithelial connective tissue graft (SCTG) is generally a reliable method for treating gingival recession, but complications such as abscesses can occur post-surgery, as reported in three cases.

These abscesses were successfully treated conservatively without recurrence, and the overall effectiveness of the root coverage procedure remained intact, indicating that while complications can arise, they do not necessarily compromise the treatment outcome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gingival/soft tissue abscess following subepithelial connective tissue graft for root coverage: report of three cases. Vastardis, S., Yukna, RA.[2004]

In a study involving 20 gingival recessions, both treatments using subepithelial connective tissue grafts (SCTG) with and without plasma rich in growth factor (PRGF) showed significant improvements in clinical parameters after 3 months.

While the SCTG+PRGF group showed slightly better outcomes, the differences in effectiveness between the two treatments were not statistically significant, indicating that PRGF may not provide additional benefits in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subepithelial connective tissue graft with and without the use of plasma rich in growth factors for treating root exposure. Lafzi, A., Faramarzi, M., Shirmohammadi, A., et al.[2022]

In a study involving 19 patients, subepithelial connective tissue graft (SCTG) sites showed significantly lower levels of plaque-induced inflammation compared to healthy untreated gingivae, suggesting SCTG is effective in managing gingival recession without increasing inflammation.

Despite higher baseline levels of the proinflammatory cytokine interleukin-1β in SCTG sites, these sites exhibited a smaller increase in inflammation upon plaque accumulation, indicating that SCTG is a safe procedure that does not predispose treated areas to further recession.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unexpected resilience to experimental gingivitis of subepithelial connective tissue grafts in gingival recession defects: a clinical-molecular evaluation. Graziano, A., Cirillo, N., Pallotti, S., et al.[2014]

The use of a subepithelial connective tissue graft (SCTG) combined with a partial thickness flap is an effective technique for correcting marginal tissue recessions, as demonstrated in a case where a 4-mm recession was successfully treated, leading to improved gingival contour.

However, complications such as the development of a gingival cyst can occur, indicated by persistent tissue bulkiness and discharge, highlighting the need for careful monitoring and potential further surgical intervention to achieve optimal results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A gingival cul-de-sac following a root coverage procedure with a subepithelial connective tissue submerged graft. Wei, PC., Geivelis, M.[2004]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9695200/

The Use of Collagen Matrix in the Treatment of Gingival ... in a 12 month study, total coverage was achieved for 8 of the 11 recessions, which gives a result of 72%, and the mean root coverage was 94.32% ...

2. researchgate.net researchgate.net/publication/365435401_The_Use_of_Collagen_Matrix_in_the_Treatment_of_Gingival_Recession-A_Pilot_Study

The Use of Collagen Matrix in the Treatment of Gingival ... The aim of this pilot study was to evaluate the effectiveness of the use of the collagen matrix combined with the coronally advanced flap ...

3. mdpi.com mdpi.com/2073-4360/12/9/2081

Current Insight of Collagen Biomatrix for Gingival Recession The results indicated that Col matrix is more effective for type II recession compared with type I. However, no significant difference was observed in both of ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40838330/

Volume-stable collagen matrix to treat gingival recession ... The recession reduction (RecRed) was the primary outcome. Results: CAF and CAF+VCMX provided significant RecRed (1.87 vs. 1.78 mm; p = 0.76) ...

5. withpower.com withpower.com/trial/phase-gingival-recession-7-2023-14ab1

Collagen Matrix After Gum Grafting for Gum Recession While the SCTG+PRGF group showed slightly better outcomes, the differences in effectiveness between the two treatments were not statistically significant, ...

6. researchgate.net researchgate.net/publication/273376716_Clinical_evaluation_of_the_effectiveness_of_using_a_collagen_matrix_MucograftR_prototype_in_gingival_recession_coverage_-_a_pilot_study

Clinical evaluation of the effectiveness of using a collagen ... ... A complete clinical healing was observed after 2 weeks in 8 out of 10 patients [25]. This is in agreement with further studies using human ...

7. mdpi.com mdpi.com/2076-3417/14/17/8049

Long-Term Outcomes of Collagen Matrix versus ... The relative risk of complete root coverage of collagen matrix compared with subepithelial connective tissue was 0.68 (95% confidence interval, ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12135576/

Comparing Connective Tissue Grafts and Collagen Matrix in ... The primary outcomes were attached gingiva width (AGW), recession depth (RD), recession width (RW), and mean root coverage% (MRC%). The ...

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

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.