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Dynamics of Wound Healing in Patients With Obesity

Temporal Dynamics of Palatal Wound Healing With and Without Adjunctive Biologics in Patients With Obesity

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 4 visits
  • Time periods mentioned: 30 days

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how body weight affects healing after tissue is taken from the roof of the mouth for a gum graft. It is for adults with obesity or normal weight who are having this surgery. It also compares two healing materials: platelet-rich fibrin (PRF), made from the person's own blood, and the usual collagen plug.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be an adult having tissue taken from the roof of your mouth for a gum graft.
  • Be able and willing to agree to join the study on your own after learning about it.
  • Keep your teeth and gums clean.
  • Have a healthy roof of your mouth, with no unusual shape, disease, or injury.
  • Have no active illness affecting your overall health or condition that slows healing, such as type 2 diabetes that is not controlled.
  • Not be pregnant.
  • Have had no blood transfusion in the past 3 months.
  • Meet the listed weight-group rules. BMI is a measure based on height and weight. For the normal-weight group: BMI below 30 and waist under 35 inches for women or over 40 inches for men. For the obesity group: BMI above 30 and waist over 35 inches for women or over 40 inches for men.

Who can't join

  • Cannot or do not want to agree to join the study on your own.
  • Take medicines that may affect healing or require changes to the planned surgery.
  • Have a history of alcohol or drug abuse.
  • Smoke now or have smoked in the past.
  • Have had surgery before in the same area.
  • Have a history of an autoimmune condition, where the body's defense system attacks its own tissues.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

IA