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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this randomized clinical trial is to compare whether soft tissue augmentation placed in the donor site following a gum graft harvesting leads to volumetric changes compared to non-augmented sites in the palate. The main questions it aims to answer are: * Are there tissue thickness changes between the two groups (control group and augmentation group)? * Are there volumetric changes in the donor site (palate) between the two groups in the short and long term? Participants will receive a gum graft and then based on what group they were randomly assigned, they will receive either a collagen matrix where the gum graft was taken (on the palate) or nothing will be placed. Researchers will compare non-augmented sites with augmented sites to see if there is a change in tissue thickness and volume.

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 data supports the effectiveness of the treatment Collagen Matrix After Gum Grafting for Gum Recession?

Research shows that subepithelial connective tissue grafts (SCTGs) are highly effective for treating gum recession, as they are considered the gold standard and have high predictability in covering exposed roots. Studies have demonstrated successful new tissue attachment and resilience to inflammation, which are important for long-term success. ^{1 2 3 4 5}

Is the subepithelial connective tissue graft (SCTG) safe for treating gum recession?

The subepithelial connective tissue graft (SCTG) is generally considered safe for treating gum recession, with few potential postoperative problems. However, complications like gingival abscesses (infections in the gums) can occasionally occur. ^{2 4 5 6 7}

How is the subepithelial connective tissue graft treatment different from other treatments for gum recession?

The subepithelial connective tissue graft (SCTG) is considered the gold standard for treating gum recession because it involves using the patient's own tissue to promote new tissue attachment, which can lead to more natural and effective healing compared to other methods like acellular dermal matrix grafts or guided tissue regeneration. ^{1 4 8 9 10}

Research Team

Ying S Wang, DDS, MS

Principal Investigator

Texas A&M School of Dentistry

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 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 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]

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]

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]

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 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]

References

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

Tunnel technique with a surgical maneuver to increase the graft extension: case report with a 3-year follow-up. [2008]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Evaluation of 2 techniques of epithelial removal in subepithelial connective tissue graft surgery: a comparative histological study. [2022]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

Subepithelial connective tissue graft with and without the use of plasma rich in growth factors for treating root exposure. [2022]

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

Histologic and Clinical Study of Gingival Recession Treated with Subepithelial Connective Tissue Graft: A Case Report. [2018]

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

Unexpected resilience to experimental gingivitis of subepithelial connective tissue grafts in gingival recession defects: a clinical-molecular evaluation. [2014]

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

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

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

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

8. Germany 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. [2021]

9. India pubmed.ncbi.nlm.nih.gov

Acellular dermal matrix and subepithelial connective tissue grafts for root coverage: A systematic review. [2022]

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

Treatment of gingival recession: comparative study between subepithelial connective tissue graft and guided tissue regeneration. [2006]