Wound Healing
Conditions
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.
Interventions
PROCEDURECollagen Plug (standard of care)
Collagen Plug (standard of care)
PROCEDUREPlatelet-Rich Fibrin Clot
Platelet-Rich Fibrin Clot is placed on wound
Sponsors
University of Iowa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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) |
Countries
United States
Contacts
CONTACTSukirth M Ganesan, DDS,PhD,MPH
PRINCIPAL_INVESTIGATORSukirth E Ganesan, DDS,PhD,MPH
University of Iowa College of Dentistry and Dental Clinics
Outcome results
None listed