Free Gingival Graft for 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 aims to evaluate how well the mouth heals after a gum graft, specifically a Free Gingival Graft, in individuals with and without diabetes. Researchers will examine factors such as the size of the healing area and the impact of elements like oral bacteria and inflammation on healing. Participants will receive treatment for gum recession and attend several follow-up visits. Suitable candidates have gum recession requiring treatment and are either diabetic or non-diabetic. As an unphased trial, this study provides a unique opportunity to enhance understanding of gum healing across diverse populations.

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 the Free Gingival Graft is safe for diabetic patients?

Studies have shown that free gingival grafts are generally safe and effective for dental procedures, even for individuals with diabetes. Research indicates that when diabetes is well managed, patients experience high success rates with similar dental procedures, around 85-95%. This demonstrates that the grafts are both effective and safe to use.

However, healing might be slower for people with diabetes. One study found that diabetes can sometimes slow wound healing after dental surgeries, slightly increasing the risk of complications. Despite this, many diabetic patients achieve good results with proper management of their condition.

In summary, while individuals with diabetes should be aware of potential risks, free gingival grafts have been shown to be a safe and effective treatment option overall.12345

Why are researchers excited about this trial?

Researchers are excited about the free gingival graft (FGG) for diabetes because it offers a promising approach to treating gingival recession in diabetic patients, a group that often faces challenges with wound healing. Unlike standard treatments like scaling and root planing or regular connective tissue grafts, the FGG involves harvesting tissue from the patient's own mouth, which can potentially improve healing outcomes by reducing rejection risks and enhancing tissue integration. This method specifically addresses the unique healing difficulties faced by diabetics, potentially leading to better and faster recovery of the gum tissue.

What evidence suggests that the Free Gingival Graft is effective for gingival recession in diabetic patients?

Research has shown that free gingival grafts (FGGs) effectively increase the width of gum tissue around teeth and implants, promoting oral health. This trial will compare the effectiveness of FGGs in diabetic and non-diabetic participants. Healing can be more challenging for people with diabetes, but studies have found that FGG can still successfully increase gum tissue width. Although diabetes might slow healing, FGG remains a common procedure to improve gum health and appearance. Specifically, research indicates that while healing may take longer for diabetics, the grafts still successfully enhance gum tissue. This makes FGG a suitable option for those with receding gums, even if they have diabetes.23678

Who Is on the Research Team?

MP

Mauro Pedrine Santamaria, DDS, Ms, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for adults (18+) with receding gums who need gum graft surgery. Both people with and without diabetes can join, as long as their gums are generally healthy and they don't have any issues with the roof of their mouth.

Inclusion Criteria

I have diabetes with HbA1c over 7% and manage it with pills or insulin.
I am 18 years old or older.
* 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 wound healing and epithelialization at 7, 14, 30, and 90 days after treatment

12 weeks
4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Free Gingival Graft

Trial Overview

The study looks at how wounds heal after a free gingival graft (gum tissue transplant) in diabetic versus non-diabetic patients. All participants receive the same gum graft procedure and attend several follow-up visits to monitor healing.

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

healing of the free gingival graft in a patient with long term ...

Despite good control of diabetes, the risk of poor wound healing is increased in long-standing patients. The patient came to our Department due to his fear of ...

Graft Dimensions and Residual Tissue Thickness Impact on ...

Free gingival grafting (FGG) is a common procedure in periodontal and implant therapy to augment keratinized tissue and improve esthetic ...

Free Gingival Graft for Diabetes · Info for Participants

The goal of this clinical trial is to evaluate local and systemic factors involved in palatal mucosal healing after Free Gingival Graft ...

The Effect of Diabetes and Hyperglycemia on Horizontal ...

Six months after the GBR procedure, the present study found a statistically significant difference in horizontal bone gain between group 1, ...

Efficacy of different interventions on the morbidity ...

This review aimed to evaluate the efficacy of different interventions used on the palatal donor area in the treatment of postoperative pain after free gingival ...

Clinical Efficacy and Safety of Local Bone Grafting Combined ...

The results demonstrate that local bone grafting combined with implant restoration achieves favorable clinical efficacy and safety in diabetic patients with ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41413925/

The Effect of Diabetes on Outcomes of Non-Surgical ...

Objective: The aim of this systematic review was to critically assess and synthesise the current scientific evidence of the potential impact of ...

Dental Implants in Diabetic Patients: Safety, Risks, and ...

Well-controlled diabetic patients experience success rates of 85-95%, only slightly lower than non-diabetic populations. Controlled diabetes ...