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临床试验/CTRI/2025/09/095104
CTRI/2025/09/095104尚未招募2 期

Comparative Evaluation Of Demineralized Freeze-Dried Bone Allograft versus Biphasic Calcium Phosphate in Periodontal Intrabony Defects Using A Radiographic Grid With The Long Cone Paralleling Technique – A Randomised Controlled Study

Dr Madhumitha C1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年11月1日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Probing Pocket Depth, Clinical Attachment Level, radiographic defect fill and defect resolution

研究概览

简要总结

A total of 15 chronic periodontitis patients aged 22–55 years with bilateral two- or three-walled defects, probing depth >5 mm, and clinical attachment loss >3 mm will be selected. Sites will be randomized into two groups using the table of random numbers under single blinding. Informed consent will be obtained after explaining the procedure, risks, and benefits. Pre-operative scaling and root planing will be done, and baseline measurements recorded after one month. Surgery will be performed under CHX rinse and povidone-iodine antisepsis. Defects will be filled with either hydrated DFDBA or hydrated BCP, both covered with a chorion membrane. The study aims to evaluate and compare bone regeneration in DFDBA and BCP groups using clinical parameters (Plaque Index, Gingival Index, Probing Pocket Depth, Clinical Attachment Level) at baseline, 3 and 6 months, assess radiographic defect fill and resolution at baseline and 6 months, and record any adverse reactions.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
25.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • 1.15 Patients aged between 25 and 55 years both Male and femalewith chronic periodontitis having intrabony defects( two-walled and three-walled defects )bilaterally in any quadrant.
  • 2.Probing pocket depth (PPD) greater than or equal to 5 mmusing UNC-15 probe.
  • 3.Clinical attachment loss ( CAL ) greater than or equal to3mm using UNC-15 probe.
  • 4.Favorable intrabony defect radiographically greater than or equal to 3mm.
  • 5.Grade I mobile tooth.
  • 6.Patient willing to participate in the study.

排除标准

  • 1.Medically compromised patients having uncontrolled Diabetes and Hypertension.
  • 2.Smokers and smokeless tobacco users 3.Pregnant women and lactating mothers 4.Grade II and III Mobile tooth 5.A patient who is unable to attend follow-up appointments.

结局指标

主要结局

Probing Pocket Depth, Clinical Attachment Level, radiographic defect fill and defect resolution

时间窗: 1 month, 3 month and 6 month

次要结局

  • Plaque index, Gingival index(1 month, 3 month and 6 month)

研究者

发起方
Dr Madhumitha C
申办方类型
Other [Self sponsered]
责任方
Principal Investigator
主要研究者

Dr Madhumitha C

Government Dental college and Hospital Mumbai

研究点 (1)

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