Wound HealingNCT07756112
Dynamics of Wound Healing in Patients With Obesity
A study testing Platelet-Rich Fibrin Clot in people with Wound Healing, run by University of Iowa at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Wound Healing
- What is being tested?
- Platelet-Rich Fibrin Clot
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2026to Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Iowa College of Dentistry and Dental Clinics
Iowa City, Iowa, 52242
Sukirth M Ganesan, (319) 467-1475, sukirth-ganesan@uiowa.edu
About this study
Official title: Temporal Dynamics of Palatal Wound Healing With and Without Adjunctive Biologics 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.
- Conditions
- Wound Healing
- Being tested
- Collagen Plug (standard of care), Platelet-Rich Fibrin Clot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen Plug (standard of care)Procedure or surgery
Collagen Plug (standard of care)
Platelet-Rich Fibrin ClotProcedure or surgery
Platelet-Rich Fibrin Clot is placed on wound
| Study group | Role | What they receive |
|---|---|---|
| Normal Weight Patients with Collagen Plug | Active comparator | Not described Receives: Procedure: Collagen Plug (standard of care) |
| Normal Weight Patients with Platelet-Rich Fibrin Clot | Experimental | Not described Receives: Procedure: Platelet-Rich Fibrin Clot |
| Obese Weight Patients with Collagen Plug | Active comparator | Not described Receives: Procedure: Collagen Plug (standard of care) |
| Obese Weight Patients with Platelet-Rich Fibrin Clot | Experimental | Not described Receives: Procedure: Platelet-Rich Fibrin Clot |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline, 30 days after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start13 Oct 2026
- Primary completionOct 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealingStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sukirth M Ganesan, BDS, PhD, University of Iowa
- Investigators
- Sukirth E Ganesan, DDS,PhD,MPH, Principal investigator, University of Iowa College of Dentistry and Dental Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07756112
- Sponsor's protocol ID
- 202601354
- Status last verified
- Oct 2026
- First submitted
- 4 Aug 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporal Dynamics of Palatal Wound Healing With and Without Adjunctive Biologics in Patients With Obesity
- ClinicalTrials.gov ID
- NCT07756112
- Acronym / sponsor ID
- 202601354
- Conditions
- Wound Healing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- 13 Oct 2026 (actual)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal Weight Patients with Collagen Plug | Active comparator | Procedure: Collagen Plug (standard of care) |
| Normal Weight Patients with Platelet-Rich Fibrin Clot | Experimental | Procedure: Platelet-Rich Fibrin Clot |
| Obese Weight Patients with Collagen Plug | Active comparator | Procedure: Collagen Plug (standard of care) |
| Obese Weight Patients with Platelet-Rich Fibrin Clot | Experimental | Procedure: Platelet-Rich Fibrin Clot |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collagen Plug (standard of care)Collagen Plug (standard of care) | Procedure or surgery | Normal Weight Patients with Collagen Plug, Obese Weight Patients with Collagen Plug |
| Platelet-Rich Fibrin ClotPlatelet-Rich Fibrin Clot is placed on wound | Procedure or surgery | Normal Weight Patients with Platelet-Rich Fibrin Clot, Obese Weight Patients with Platelet-Rich Fibrin Clot |
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sukirth E Ganesan, DDS,PhD,MPH principal investigator
University of Iowa College of Dentistry and Dental Clinics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet-Rich Fibrin Clot in people with Wound Healing, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sukirth M Ganesan, DDS,PhD,MPH (319-467-1475, sukirth-ganesan@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.