Gingival Treatment for Gum Recession in Diabetes

DG
Overseen ByDawn G Dawson
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of a specific gum treatment for individuals with and without diabetes. It seeks to determine if healing after treatment differs between these groups. The trial will also investigate factors such as oral bacteria and inflammation that might influence healing. Individuals with diabetes managed by medication or insulin who require treatment for receding gums may qualify. Participants will undergo a gum treatment procedure called Coronally Advance Flap with connective tissue graft (CAF+CTG) and attend several follow-up visits to provide samples and answer questions. As an unphased study, this trial offers a unique opportunity to enhance understanding of gum healing in diverse patient groups.

Will I have to stop taking my current medications?

The trial requires that you do not take medications known to interfere with wound healing or that contraindicate the surgical procedure. If you are on such medications, you may need to stop them to participate.

What prior data suggests that this gingival treatment is safe for diabetic and non-diabetic patients?

Studies have shown that combining a coronally advanced flap with a connective tissue graft (CAF+CTG) is generally well-tolerated. Research indicates this method effectively covers exposed roots caused by gum recession. Many patients maintain stable results for up to 18 months post-procedure.

Although some soft tissue shrinkage may occur, the overall safety profile remains good. Most people do not report serious side effects, and various studies have used the treatment successfully. Participants should discuss any concerns with their healthcare provider to ensure it is a suitable option for them.12345

Why are researchers excited about this trial?

Researchers are excited about the Coronally Advance Flap associated with a connective tissue graft (CAF+CTG) for treating gum recession in people with diabetes because it offers a unique approach. Unlike standard treatments that might only involve scaling and root planing or medications to manage gum health, CAF+CTG physically restores gum tissue, possibly providing a more effective and lasting solution. This method combines a surgical technique that advances the gum tissue with a graft that encourages natural tissue regeneration, potentially leading to better coverage of exposed roots and improved gum stability. This could be particularly beneficial for diabetic patients, who often face challenges in wound healing.

What evidence suggests that this treatment might be an effective treatment for gum recession in diabetes?

Studies have shown that using a Coronally Advanced Flap with a connective tissue graft (CAF+CTG) effectively reduces gum recession. Patients treated with this method often experience significant improvement, as the treatment covers the exposed roots of their teeth. Research comparing CAF+CTG with other treatments indicates it achieves similarly good results in reducing gum recession. This trial will evaluate CAF+CTG in two groups: patients with diabetes and patients without diabetes. The method aims to cover exposed roots, which is crucial for individuals with gum recession. Overall, CAF+CTG has successfully managed gum recession, making it a promising option for patients with this condition.12346

Who Is on the Research Team?

MS

Mauro Santamaria, DDS, MS, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for adults (18+) with gum recession who need treatment, including both people with and without diabetes. Participants must have stable gums, no major mouth issues, and be able to attend follow-up visits.

Inclusion Criteria

I have diabetes with HbA1c over 7% and manage it with pills or insulin.
I need treatment for gum recession with a visible or restored tooth CEJ.
* periodontal stable (BoP ≤25%)(Lang et al. 2003);
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the procedure to treat their gingival recession defects

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
5 visits (in-person) at 7, 14, 30, 90, and 180 days

What Are the Treatments Tested in This Trial?

Interventions

  • Coronally Advance Flap associated with connective tissue graft (CAF+CTG)

Trial Overview

The study tests a surgical procedure called coronally advanced flap with connective tissue graft (CAF+CTG) to treat receding gums. It compares healing in diabetic versus non-diabetic patients through exams, sample collection, and questionnaires over six months.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Diabetes groupExperimental Treatment1 Intervention
Group II: Non-diabetes groupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mauro Santamaria

Lead Sponsor

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/31762155/

Coronally advanced flap with connective tissue graft or ...

M-CAF combined with XADM or CTG seems to be similarly effective in RD reduction of class I and II MGRs at least in the short term.

Study of Hyaluronic Acid Used With Gum Surgery to Treat ...

A commonly used surgical treatment is the coronally advanced flap combined with a connective tissue graft (CAF + SCTG), which aims to cover the exposed root and ...

Coronally advanced flap and connective tissue graft with or ...

This study showed that treating gingival recession lesions with CAF+CTG versus CAF+CTG+PRGF yields similarly favorable results.

Coronally Advanced Flap in the Treatment of Multiple ...

The aim of this study was to compare the treatment outcome of MAGR coverage by a coronally advanced flap (CAF) along with a connective tissue graft (CTG)

Comparison of Coronally Advanced Flap and Connective ...

The addition of EMD to CAF+CTG results in a greater amount of root coverage in teeth treated for gingival recessions.

6.

researchrepository.wvu.edu

researchrepository.wvu.edu/etd/12430/

"Comparison between Coronally Advanced Flap with Sub ...

The results indicate that TUN + CTG for the management of multiple recession defects shows no statistically significant difference in terms of mean root ...