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临床试验/CTRI/2025/04/084584
CTRI/2025/04/084584尚未招募不适用

Comparative evaluation of Demineralised Freeze Dried Bone Allograft with & without Doxycycline hyclate loaded Proniosomal gel in the treatment of Class II Furcation defects: A Randomized Controlled Trial.

Dr. Vaishnavi Biradar1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2025年4月29日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
28
试验地点
1
主要终点
To evaluate & compare the efficacy of

研究概览

简要总结

This randomized clinical study will include 28 patients both males and females visiting the department of Periodontics and Implant Dentistry diagnosed with Stage III Periodontitis and exhibiting Class II furcation defects. Two sites in each patient will be assigned randomly for sampling as follows- It will be conducted in Department of Periodontics and Implant Dentistry, after taking informed consent from the patient. All the clinical and radiographical parameters will be evaluated at baseline after which the sites in the patients will be randomly and equally divided into Test and Control groups to be treated with doxcycline hyclate gel with DFDBA and DFDBA alone respectively in Class II furcation defects in Stage III Periodontiits patients. The study will be initiated after clearance from the Institutional Ethics Committee. For each patient two sites will be randomly assigned as;

Group I: (28 - Control Group) – Stage III Periodontitis exhibiting Class II furcation defects to be treated with DFDBA bone graft alone. Group II: (28- Test Group) – Stage III Perioodntitis exhibiting Class II furcation defects to be treated with doxcycline gel with DFDBA . INCLUSION CRITERIA: 1) Patients with Stage III periodontitis as assessed by Probing Pocket Depth (PPD) ? 6mm, interdental clinical attachment level (CAL) ? 5 mm and Horizontal Probing Depth (HPD) ? 2mm. 2) Patients with at least two class II furcation defects in either maxillary or mandibular arch. EXCLUSION CRITERIA: 1) Patients with a history of allergies, Systemic diseases or drug usage. 2) Patients who have undergone periodontal surgery in previous 6 months. 3) Pregnant or lactating women. 4) Smokers, tobacco chewers and patients with poor oral hygiene index (PI>1.5) will be excluded from the study. 5) Carious teeth or teeth with mobility > Class II

研究设计

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

入排标准

年龄范围
30.00 Month(s) 至 60.00 Month(s)(—)
性别
All

入选标准

  • Patients with Stage III periodontitis as assessed by Probing Pocket Depth (PPD) 2) 6mm, interdental clinical attachment level (CAL) 3) 5 mm and Horizontal Probing Depth (HPD) 2mm Patients with at least two class II furcation defects in either maxillary or mandibular arch.

排除标准

  • Patients with a history of allergies, Systemic diseases or drug usage.
  • Pregnant or lactating women.

结局指标

主要结局

To evaluate & compare the efficacy of

时间窗: Baseline, 3 months and 6 months

doxycycline hyclate loaded proniosomal gel in

时间窗: Baseline, 3 months and 6 months

combination with DFDBA & DFDBA alone in the

时间窗: Baseline, 3 months and 6 months

treatment of Class II furcation defects

时间窗: Baseline, 3 months and 6 months

radiographically by CBCT.

时间窗: Baseline, 3 months and 6 months

次要结局

  • To assess Clinical Attachment Level (CAL),(Probing Pocket Depth (PPD) ,Horizontal Probing)

研究者

发起方
Dr. Vaishnavi Biradar
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Vaishnavi Biradar

Reader and Guide

研究点 (1)

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