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NCT Number: NCT07756112

Dynamics of Wound Healing in Patients With Obesity

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.

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Key information

Conditions

Wound Healing

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa College of Dentistry and Dental Clinics

Iowa City, Iowa, 52242, United States

Location contact

Sukirth M Ganesan

CONTACT

[email protected]

(319) 467-1475

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Collagen Plug (standard of care)

Procedure

Collagen Plug (standard of care)

Platelet-Rich Fibrin Clot

Procedure

Platelet-Rich Fibrin Clot is placed on wound

Primary outcomes

  1. 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

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Sukirth M Ganesan, DDS,PhD,MPH

CONTACT

[email protected]

319-467-1475

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Registry information

Official study title

Temporal Dynamics of Palatal Wound Healing With and Without Adjunctive Biologics in Patients With Obesity

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 10, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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