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Gingival Treatment for Gum Recession in Diabetes

DG
Overseen ByDawn G Dawson
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Mauro Santamaria
Must not be taking: Wound healing inhibitors
Disqualifiers: Cardiovascular, Blood dyscrasias, Immunodeficiency, others
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?

The goal of this clinical trial is to evaluate local and systemic factors involved in oral mucosal healing after gingival recession treatment in diabetic patients and to compare them with those in non-diabetic patients.

Diabetic and non-diabetic volunteers of both sexes aged ≥ 18 years with gingival recession may participate. The main questions it aims to answer are:

1. If the gingival recession reduction and percentage of root coverage are different in diabetics compared to non-diabetics.

2. If different factors, such as the oral microbiome, inflammatory markers, and others, are associated with the clinical outcome.

Participants will be asked:

* Receive the procedure to treat their gingival recession defects

* To attend follow-up visits at 7, 14, 30, 90, and 180 days after treatment.

* To provide different biological samples

* To answer different questionnaires.

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?

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)

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

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