Dynamics of Wound Healing in Patients With Obesity

ConditionWound Healing

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-70

SponsorUniversity of Iowa

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Collagen Plug (standard of care)
Procedure/Surgery
Collagen Plug (standard of care)
Platelet-Rich Fibrin Clot
Procedure/Surgery
Platelet-Rich Fibrin Clot is placed on wound

Treatment groups

104 Participants

are divided into 4 treatment groups

Group A: Normal Weight Patients with Collagen PlugActive comparator 1 intervention

Group B: Normal Weight Patients with Platelet-Rich Fibrin ClotExperimental treatment 1 intervention

Group C: Obese Weight Patients with Collagen PlugActive comparator 1 intervention

Group D: Obese Weight Patients with Platelet-Rich Fibrin ClotExperimental treatment 1 intervention

Trial 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

Sponsors and contacts

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University of Iowa

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: