Temporal Dynamics of Palatal Wound Healing With and Without Adjunctive Biologics in Patients With Obesity
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Normal Weight Patients with Collagen Plug
干预措施: Collagen Plug (standard of care) (Procedure)
Normal Weight Patients with Platelet-Rich Fibrin Clot
干预措施: Platelet-Rich Fibrin Clot (Procedure)
Obese Weight Patients with Collagen Plug
干预措施: Collagen Plug (standard of care) (Procedure)
Obese Weight Patients with Platelet-Rich Fibrin Clot
干预措施: Platelet-Rich Fibrin Clot (Procedure)
结局指标
主要结局
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
时间窗: 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)
次要结局
未报告次要终点
研究者
Sukirth M Ganesan, BDS, PhD
Associate Professor
University of Iowa