NCT07756112

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
37mo left

Started Aug 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Aug 2026Aug 2029

Study Start

First participant enrolled

August 1, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 4, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 10, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2029

Last Updated

August 10, 2026

Status Verified

July 1, 2026

Enrollment Period

3 years

First QC Date

August 4, 2026

Last Update Submit

August 4, 2026

Conditions

Wound Healing

Outcome Measures

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)

    Baseline, 30 days after baseline

Study Arms (4)

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

Interventions

Collagen Plug (standard of care)PROCEDURE

Collagen Plug (standard of care)

Normal Weight Patients with Collagen PlugObese Weight Patients with Collagen Plug
Platelet-Rich Fibrin ClotPROCEDURE

Platelet-Rich Fibrin Clot is placed on wound

Normal Weight Patients with Platelet-Rich Fibrin ClotObese Weight Patients with Platelet-Rich Fibrin Clot

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa College of Dentistry and Dental Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Sukirth E Ganesan, DDS,PhD,MPH

    University of Iowa College of Dentistry and Dental Clinics

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sukirth M Ganesan, DDS,PhD,MPH

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 4, 2026

First Posted

August 10, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

August 1, 2029

Last Updated

August 10, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)