ClinicalTrials.gg
RecruitingNCT07756112Updated Oct 22, 2026

Dynamics of Wound Healing in Patients With Obesity

An interventional study of Collagen Plug (standard of care) and Platelet-Rich Fibrin Clot in Wound Healing, sponsored by University of Iowa. Recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by University of Iowa · Not applicable, Interventional, and Treatment

Updated Oct 22, 2026Now RecruitingSite recruiting status changed+4 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
104
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Wound Healing
03

In context

Lead sponsor

University of Iowa is the lead sponsor of 279 studies on the registry; 33 are open to participants now.

Of its 45 completed or terminated interventional studies of FDA-regulated products, 40 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 22, 2026. See what changed

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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 ( 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

Exclusion Criteria:

  • Are unable or unwilling to provide your own .
  • 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 disease or condition.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
104 participants (estimated)

Study arms

  • Active comparator
    Normal Weight Patients with Collagen Plug

    Procedure: Collagen Plug (standard of care)

  • Experimental
    Normal Weight Patients with Platelet-Rich Fibrin Clot

    Procedure: Platelet-Rich Fibrin Clot

  • Active comparator
    Obese Weight Patients with Collagen Plug

    Procedure: Collagen Plug (standard of care)

  • Experimental
    Obese Weight Patients with Platelet-Rich Fibrin Clot

    Procedure: Platelet-Rich Fibrin Clot

Interventions

  • ProcedureCollagen Plug (standard of care)

    Collagen Plug (standard of care)

  • ProcedurePlatelet-Rich Fibrin Clot

    Platelet-Rich Fibrin Clot is placed on wound

06

What researchers measure

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

    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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Oct 22, 2026
Sites
University of Iowa College of Dentistry and Dental Clinics is now Recruiting
Oct 22, 2026
Start date
Aug 2026→Oct 13, 2026 (actual)
Oct 22, 2026
Primary completion
Aug 2029→Oct 2029
Oct 22, 2026
Study completion
Aug 2029→Oct 2029
Oct 22, 2026
Eligibility
1 inclusion criterion edited
What changed in the criteria
Inclusion criteria
  • ChangedBefore Be an adult who is having tissue taken from the roof of the mouth as part of a gum graft procedure.Now Be an adult who is undergoing any surgical procedure or volunteering to be part of the study
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    Not yet recruiting→Recruiting
    University of Iowa College of Dentistry and Dental Clinics is now Recruiting
    Start date Aug 2026→Oct 13, 2026 (now actual)
    Primary completion Aug 2029→Oct 2029
    Study completion Aug 2029→Oct 2029
    Eligibility 1 inclusion criterion edited
    What changed in the criteria
    Inclusion criteria
    • ChangedBefore Be an adult who is having tissue taken from the roof of the mouth as part of a gum graft procedure.Now Be an adult who is undergoing any surgical procedure or volunteering to be part of the study
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07756112
Lead sponsor
University of Iowa
Responsible party
Sukirth M Ganesan, BDS, PhD (Associate Professor, University of Iowa) — Principal investigator
First posted
Aug 10, 2026
Start date
Oct 13, 2026
Primary completion
Oct 2029 (estimated)
Completion
Oct 2029 (estimated)
Last update
Oct 22, 2026

Study contacts

Sukirth M Ganesan, DDS,PhD,MPH
Contact
sukirth-ganesan@uiowa.edu
319-467-1475
Sukirth E Ganesan, DDS,PhD,MPH
principal investigator · University of Iowa College of Dentistry and Dental Clinics

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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