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临床试验/CTRI/2025/08/093848
CTRI/2025/08/093848已完成不适用

Efficacy of Concentrated Growth Factor (CGF) in enhancing soft tissue healing in active smokers.

Anamika B S1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2025年9月15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
42
试验地点
1
主要终点
To evaluate the efficacy of concentrated growth factor in enhancing soft tissue healing after surgical removal of mandibular 3rd molars in active smokers

研究概览

简要总结

The purpose of this research is to evaluate the efficacy of concentrated growth factor  in promoting soft tissue healing and preventing alveolar osteitis in active smokers.

Patients reporting to the outpatient department of PMS College of Dental Science and Research indicated for surgical extraction of mandibular third molar who fulfill the inclusion criteria will be included in the study.

Informed consent will be obtained from the patient.

After surgical removal of mandibular 3rd molar, CGF in gel form will be inserted into the socket in the study group. Absorbable gelatin sponge will be placed in the socket of the control group.

CGF will be prepared by collecting two 10 mL blood samples from the patient. The tubes will be centrifuged in centrifuge device immediately to prevent coagulation of blood. The guidelines of centrifugation to be followed are acceleration for 30 sec so as to reach 2700 rpm, rotated for 2 mins, then reduced to 2400 rpm, for 4 mins and then accelerated to 2700 rpm for 4 mins, then accelerated to 3000 rpm for 3 mins, and decelerated for 36 sec to stop.

3 layers that will be obtained in the tube are

1)Upper platelet poor plasma

2)Middle buffy coat containing CGF fibrin gel

3)Lower red blood cells

The middle buffy coat containing the CGF layer will be taken out of the tube and split from the red blood cells.

CGF fibrin gel will be then placed into the patient’s extraction socket and wound closure completed with silk suture.

Every patient will be recalled on day 4 day of surgery to evaluate healing progress. The onset of alveolar osteitis will be recorded based on the clinical appearance of the socket that will be quantified on a scoring system elaborated below.10 Sutures will be removed at day10 after surgery. Soft tissue healing will be evaluated.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients over 18 years of age who need to undergo surgical removal of mandibular third molars and at risk of developing alveolar osteitis.
  • Patients classified ASA I and ASA II 2) Active smokers 3) Consenting for the study.

排除标准

  • Patients aged less than 18 years 2) Immunocompromised patients 3) Patients with active infection 4) Pregnant females 5) Patients with history of blood dyscrasias.

结局指标

主要结局

To evaluate the efficacy of concentrated growth factor in enhancing soft tissue healing after surgical removal of mandibular 3rd molars in active smokers

时间窗: 4th day,10th day

次要结局

  • To evaluate the efficacy of concentrated growth factor in reducing the incidence of alveolar osteitis after surgical removal of mandibular 3rd molars in active smokers(4th day)

研究者

发起方
Anamika B S
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Anamika B S

PMS College of Dental Science and Research

研究点 (1)

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