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临床试验/CTRI/2025/02/081201
CTRI/2025/02/081201尚未招募4 期

COMPARATIVE RADIOGRAPHIC EVALUATION OF BONE REGENERATION AT MANDIBULAR SYMPHYSIS AND PARASYMPHYSIS FRACTURE SITE WITH OR WITHOUT APPLICATION OF PLATELET RICH PLASMA (PRP).

KRISHNA VISHWA VIDYAPEETH1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年3月7日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
WOULD BE ASSESSED THROUGH EVALUATING BONE REGENERATION BY COMPARING STUDY WITH CONTROL GROUPS

研究概览

简要总结

This is a prospective, comparative, clinical study in patients with mandibular symphysis and/or parasymphysis fractures requiring Open Reduction Internal Fixation (ORIF) reporting to the Department of Oral and Maxillofacial Surgery, SDS, KVV, Karad.

20 patients with symphysis and parasymphysis fracture will be randomly divided into control and study groups. Only in study group patients PRP placement over fracture site will be done. All patients will be followed up for 6 months. Radiovisiography (RVG) will be taken of fracture site immediate postoperatively, 1 month and 6 months postoperatively. Radiographic intensity will be compared by using pixel size and resolution in Microsoft Paint Software at immediate post-operative, 1 month follow up and 6 month follow up period. Data will be statistically analysed.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
25.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • patients with mandibular fractures, serum paltelet count above 1.5 lakhs, with no comorbidities.

排除标准

  • a) Fracture sites with signs of infection.
  • b) Patient with bone disease.
  • c) Medically compromised patients d) Non-ambulatory patients.

结局指标

主要结局

WOULD BE ASSESSED THROUGH EVALUATING BONE REGENERATION BY COMPARING STUDY WITH CONTROL GROUPS

时间窗: IMMEDIATE POST OPERATIVE PERIOD, 1 MONTH, 6 MONTHS

次要结局

  • WPULD BE ASSESSED AFTER 6 MONTHS(IMMEDIATE POST OP, 1 MONTH, 6 MONTHS)

研究者

发起方
KRISHNA VISHWA VIDYAPEETH
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

DR DIMPLE VIJAY CHAUDHARI

KRISHNA VISHWA VIDYAPEETH, SCHOOL OF DENTAL SCIENCES , KARAD

研究点 (1)

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