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临床试验/NCT07637838
NCT07637838已完成不适用

Characterizing the Effects of Leukocyte-Platelet-Rich Fibrin on Sleep and Perceived Quality of Life on Mucogingival Periodontal Surgery Healing. Arm 1: Influence of Platelet-rich Fibrin on Quality of Life Following Mucogingival Surgery: A Randomized Controlled Trial.

59th Medical Wing1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2024年5月24日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
78
试验地点
1

研究概览

简要总结

The goal of this clinical trial (2-arm) is to determine if the application of platelet rich fibrin (PRF) to palatal donor sites influence patients quality of life, sleep efficiency, and healing following mucogingival surgery. All patients were enrolled in the Air Force Post Graduate Dental School periodontics program and each patient required mucogingival surgery. The main question[s] it aims to answer [is/are]:

  • Does the application of PRF to palatal donor sites influence patient's quality of life following mucogingival surgery. [outcome measure 1]
  • Does the application of PRF to palatal donor sites influence patient's sleep quality following mucogingival surgery. [outcome measure 2]
  • Does the application of PRF to palatal donor sites influence palatal healing following mucogingival surgery. [outcome measure 3] Researchers will compare the application of PRF (test) as a palatal dressing to a commercially available product (control; oxidized cellulose membrane or collagen dressing) to determine the difference of effects.

Participants will be randomly assigned to either receiving PRF or a commercially available product on the day of surgery. A survey response will be conducted at five time points (pre-operative, 24-hours, 72 hours, 1 week, 2 week) to obtain a quality of life metric. Sleep data was collected via a wearable device one week pre-surgical intervention and two weeks postoperatively. Finally, a clinical healing index was performed at 1 and 2 weeks post-operatively to obtain a healing score.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age > 18 or < 99
  • required a mucogingival surgery
  • had not taken an antibiotic for one month
  • planned for a non-emergent periodontal procedure

排除标准

  • pregnant or within 6 months post-partum
  • female subjects who are nursing
  • subjects who are decisionally challenged
  • patients who have undergone antibiotic therapy in the past month
  • ASA IV or higher status
  • patients who have undergone chronic therapy with medications that could affect periodontal status or healing
  • incompatible mobile phone devices.

研究者

发起方
59th Medical Wing
申办方类型
Fed
责任方
Principal Investigator
主要研究者

David Seiler

Periodontics Resident, Air Force Officer

59th Medical Wing

研究点 (1)

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