Collagen Matrix After Gum Grafting for Gum Recession

YS

HB

Overseen ByHailey Bivens, DDS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hailey Bivens

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

Approved in 1 JurisdictionThis treatment is already approved in other countries

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.12345

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.26789

Who Is on the Research Team?

YS

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.

See 9 more

Exclusion Criteria

I do not have active gum disease.

Smokers or users of nicotine replacement products

Drug or alcohol abuse history

See 12 more

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?

Treatment groups

Experimental Treatment

Active Control

Group I: Collagen MatrixExperimental Treatment1 Intervention

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

Group II: ControlActive Control1 Intervention

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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hailey Bivens

Lead Sponsor

Trials

1

Recruited

40+

Published Research Related to This Trial

Citations