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临床试验/CTRI/2023/08/056222
CTRI/2023/08/056222已完成2/3 期

Comparative assessment of Clinical and Radiographic outcomes of Sticky Bone alone and Sticky Bone with Connective Tissue Graft in treatment of Grade II Furcation defects in Mandibular Molars

GOVERNMENT COLLEGE OF DENTISTRY1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年10月8日最近更新:

试验速览

阶段
2/3 期
状态
已完成
入组人数
30
试验地点
1
主要终点
To evaluate the effectiveness of combination of autogenous connective tissue graft with sticky bone in comparison to sticky bone alone in treatment of grade II furcation defects in mandibular molars

研究概览

简要总结

·         Selection of patients with Grade IIfurcation defects in molars and their random allocation to 2 different groups.

·         After adequate local anesthesia, a full-thickness mucoperiosteal flaps will be raised around the grade 2 furcation defect to expose the defect. The defects will be randomly assigned to one of the following treatment modalities at the time of surgery:

Group 1 (test group)    -   connective tissue graft + i-PRF + perioglass  (sticky bone graft)

Group 2 (control group)  - i-PRF + perioglas  (sticky bone graft)

In group 1 patients, the furcation defect will be filled with sticky bone (i-PRF and bone graft perioglas.

·   In group 2 patients ,the furcation defect will be filled first with sticky bone (i-PRF and bone graft (perioglas)  then sub epithelial  connective tissue graft obtained from palate will  then be deposed over the defect.

·  Injectable Platelet Rich Fibrin (i-PRF) will be prepared from patient’s own blood centrifuged at 700 rpm for 3 min. Then bone graft granules will be mixed with it to obtain sticky bone.

·  Patient will be evaluated after 6 months post-operatively.

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 Blinded

入排标准

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

入选标准

  • Systemically healthy male or female patients aged between 18 years to 60 years who are willing to give their consent Patient with at least one mandibular molar tooth with grade II furcation defect Patients having vertical probing pocket depth (PPD) ≥5 mm, and ≥3 mm of horizontal probing depth but not entirely through furcation Patients willing to follow recommended plaque control and follow up regimen Patients having no history of any medication affecting periodontal healing.

排除标准

  • History of systemic diseases like diabetes mellitus, hypertension,chronic obstructive pulmonary diseases.
  • Patients with other types of furcation defects like grade I, III and IV.
  • Patients with grade 2 or 3 tooth mobility in molars.
  • Patients with severe cervical abrasion ,root caries, vertical bone loss and tooth mobility.
  • Smokers and tobacco users Patients with poor oral hygiene Pregnant and lactating women Psychiatric illness Unwillingness to return for the follow-up.

结局指标

主要结局

To evaluate the effectiveness of combination of autogenous connective tissue graft with sticky bone in comparison to sticky bone alone in treatment of grade II furcation defects in mandibular molars

时间窗: BASELINE AND 6 MONTHS

次要结局

  • 1.To evaluate and compare the soft tissue thickness of gingiva postoperatively around the treated sites.(2 To evaluate and compare the position of marginal gingiva postoperatively around the treated sites)

研究者

申办方类型
Government medical college

研究点 (1)

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