Recruiting

PRF & Collagen Plug

Sponsor:

University of Iowa

Code:

NCT07756112

Conditions

Wound Healing

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Collagen Plug (standard of care)

Platelet-Rich Fibrin Clot

Study Details

Brief summary:

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.

Conditions

Wound Healing

Study ID

NCT07756112

Start date

Oct 13, 2026

Status verified date

Oct, 2026

Completion date

Oct, 2029

Anticipated

Primary completion date

Oct, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Be an adult who is undergoing any surgical procedure or volunteering to be part of the study
  • 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.

Study Design

Enrollment

104 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Normal Weight Patients with Collagen Plug

experimental: Normal Weight Patients with Platelet-Rich Fibrin Clot

active comparator: Obese Weight Patients with Collagen Plug

experimental: Obese Weight Patients with Platelet-Rich Fibrin Clot

Interventions

Collagen Plug (standard of care)

Collagen Plug (standard of care)

Platelet-Rich Fibrin Clot

Platelet-Rich Fibrin Clot is placed on wound

Primary outcome measure

  • 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 [ Time Frame: Baseline, 30 days after baseline ]

Central Contacts and Locations

Central contacts

Sukirth M Ganesan, DDS,PhD,MPH

319-467-1475sukirth-ganesan@uiowa.edu

Locations

University of Iowa College of Dentistry and Dental Clinics

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Sukirth M Ganesan

(319) 467-1475sukirth-ganesan@uiowa.edu

More Information

Sponsor

University of Iowa

Last update posted

Oct 22, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by University of Iowa on 2026-10-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.