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临床试验/CTRI/2024/09/074332
CTRI/2024/09/074332尚未招募不适用

Clinical and radiographic evaluation of Poly Glycolic Acid / Poly Lactic Acid and hydroxyapatite paste in the treatment of periodontal intrabony defects:A randomized controlled clinical trial

vydehi institute of dental sciences and research centre1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年9月30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
24
试验地点
1
主要终点
Change in probing depth

研究概览

简要总结

This study is a randomized controlled split mouth clinical trial comparing the clinical and radiographic evaluation of Poly Glycolic Acid/Poly Lactic Acid and hydroxyapatite paste (fisiograft HA paste) with hydroxyapatite bone graft in the treatment of periodontal intrabony defects that will be conducted in Vydehi institute of dental sciences,Bangalore ,India. The primary outcome measures will be change in probing depth,Change in Relative attachment level and  percentage of bone fill at the end of 9 months of surgery The secondary outcomes will be Plaque index, Gingival index and clinical attachment level at the end of 9 months of the study.

研究设计

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

入排标准

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

入选标准

  • Patients within the age group of 35 to 60 years.
  • Patients with stage III and stage IV periodontitis according to 2017 world workshop on periodontal and peri implant diseases and conditions.12 Presence of minimum of 16 natural teeth.
  • Presence of bilateral intrabony defects on Maxillary and mandibular premolar and molar teeth with the presence of two wall or three wall intra bony defect detected on radiograph.

排除标准

  • Medically compromised patients Patients on any medications known to affect the outcomes of periodontal therapy.
  • Pregnant or lactating women Smokers or subjects using any form of tobacco 1 wall- intrabony defect Grade II and grade III mobile tooth.

结局指标

主要结局

Change in probing depth

时间窗: Change in probing depth | Change in Relative attachment level at baseline, 3 months 6 months and 9 months | Percentage of bone fill

Change in Relative attachment level

时间窗: Change in probing depth | Change in Relative attachment level at baseline, 3 months 6 months and 9 months | Percentage of bone fill

Percentage of bone fill

时间窗: Change in probing depth | Change in Relative attachment level at baseline, 3 months 6 months and 9 months | Percentage of bone fill

次要结局

  • Plaque index by Silness and Loe 1964(Gingival index by Loe and Silness 1963)

研究者

发起方
vydehi institute of dental sciences and research centre
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Nileena Dilip

Rajiv Gandhi university of health sciences

研究点 (1)

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