NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Dynamics of Wound Healing in Patients With Obesity
Dynamics of Wound Healing in Patients With Obesity

NCT07756112

Not Yet RecruitingNA

Sponsor: University of Iowa

Conditions: Wound Healing

Interventions: Collagen Plug (standard of care), Platelet-Rich Fibrin Clot

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (1)
  • Iowa City, Iowa, United States