Dynamics of Wound Healing in Patients With Obesity

N/ANot Yet RecruitingNCT07756112

University of Iowa104 enrolled

Overview

Healing after dental surgery can vary from person to person. This study is being done to understand how body weight (obesity vs. normal weight) may affect healing after tissue is removed from the roof of the mouth during a gum graft procedure. The study will also evaluate whether a healing material made from a participant's own blood, called platelet-rich fibrin (PRF), is comparable in quantity and quality to the standard-of-care collagen plug. First, participants will be classified into obese or normal weight groups. Next, participants will be randomized to receive either collagen plug or platelet-rich fibrin clot during their surgical procedure Then, participants will return for 4 visits up to 30 days from the surgery visit.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

104

Conditions

Wound Healing

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Be an adult who is having tissue taken from the roof of the mouth as part of a gum graft procedure. * Be able and willing to give informed consent on their own. * Have good oral hygiene (keep their teeth and gums clean). * Have a healthy roof of the mouth with no unusual shape, disease, or injury. * Not have any active illness affecting their overall health. * Not have a medical condition that can slow wound healing, such as uncontrolled type 2 diabetes. * Not currently pregnant. * Not have received a blood transfusion in the last 3 months. * For normal-weight group (BMI less than than 30 kg/m2, waist circumference less than 35 inches for women or greater than 40 inches for men) or for obesity group (BMI greater than 30 kg/m2, waist circumference greater than 35 inches for women and greater than 40 inches for men). Exclusion Criteria: * Are unable or unwilling to provide your own informed consent. * Take medications that may affect healing or require changes to the planned surgery. * Have a history of alcohol or drug abuse. * Currently smoke or have smoked in the past. * Have had surgery before in the area where the current procedure will be performed. * Have a history of an autoimmune disease or condition.

Outcomes

Primary Outcomes

Change in Growth Factor Quality between Normal and Obese Patients who received either Platelet-Rich Fibrin Clot or Collagen Plug at 30 days after baseline

Change in Growth Factor Quality between Normal and Obese Patients who received either Platelet-Rich Fibrin Clot or Collagen Plug at 30 days after baseline, as assessed by Enzyme-Linked Immunosorbent Assay (ELISA)

Time frame: Baseline, 30 days after baseline