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临床试验/NCT07257328
NCT07257328已完成不适用

Comparison of Injectable Platelet-Rich Fibrin (i-PRF) Application and Routine Surgical Extraction on Socket Healing Using a Split-Mouth Technique.

Saglik Bilimleri Universitesi1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
1
主要终点
Evaluation of socket healing

研究概览

简要总结

The aim of this study is to compare extraction socket healing (SH) following surgical extraction of lower third molars (LTMs) with and without the application of injectable platelet rich fibrine (i-PRF). A minimum of 32 participants will be included. One mandibular third molar per participant will be randomly assigned to the control group and the contralateral tooth to the test group. SH, gingival recession, and distal periodontal pocket depth of the adjacent second molar will be assessed, and outcomes compared between sides.

详细描述

Surgical extraction of lower third molars (LTMs) is the most commonly performed procedure in oral and maxillofacial surgery (OMFS). Healing of the extraction socket is a key outcome in oral surgery, as complications in healing may lead to delayed recovery, persistent pain, infection, and adverse events such as dry socket. The aim of this study is to compare extraction socket healing (SH) following surgical extraction of LTMs with and without the application of injectable platelet rich fibrine (i-PRF). For this purpose minimum 32 participants from both sexes will be included to the study. For each participant, one LTM (right or left) will be randomly assigned to the control group and the contralateral tooth to the test group. In the control group, the extraction socket will be irrigated with 0.9% physiological saline solution following standard extraction, whereas in the test group, the socket will be irrigated with i-PRF. SH will be assessed on postoperative days 3 and 14, and at 6 weeks, using the Inflammatory Proliferative Remodeling (IPR) scale and the hydrogen peroxide (H₂O₂) test. Gingival recession and the depth of the periodontal pocket at the distal aspect of the adjacent second molar will be recorded on postoperative days 7 and 14. The outcomes will be compared between the two sides with respect to wound healing.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

The investigators who performed clinical measurements were not involved in the operation and were blinded as to which treatment group the tooth was assigned.

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Individuals of both sexes Age over 18 years Non-smokers Systemically healthy (ASA I) Requiring surgical extraction of bilateral mandibular third molars

排除标准

  • •Lack of consent to participate Pregnancy Smokers

研究组 & 干预措施

Control group

Placebo Comparator

In the control group, routine surgical extraction will be performed, and the extraction socket will be irrigated with 0.9% physiological saline.

干预措施: Surgical extraction of lower third molars. (Procedure)

Test group

Experimental

In the test group, routine surgical extraction will be performed, and the extraction socket will be irrigated with i-PRF.

干预措施: Surgical extraction of lower third molars. (Procedure)

结局指标

主要结局

Evaluation of socket healing

时间窗: 6 weeks

Socket healing of the extracted tooth will be evaluated by using IPR scale which allows to evaluate the healing process according to its biological phases.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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