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临床试验/CTRI/2023/10/059043
CTRI/2023/10/059043尚未招募不适用

Comparative evaluation of bioactive calcium phosphosilicate graft with enamel matrix derivative in the treatment of three wall intrabony defects: A Randomized Controlled Study

Dr Anjali Batra1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2023年10月31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
45
试验地点
1
主要终点
Primary- There is no difference seen in clinical parameters and bone fill levels in patients with or without graft placement.

研究概览

简要总结

Primary objective1. To evaluate the clinical parameters and bone fill of bioactive calcium phospho-silicate graft in the treatment of three wall intrabony defects at different time intervals. 2. To evaluate the clinical parameters and bone fill of bioactive calcium phospho-silicate graft with enamel matrix derivative in the treatment of three wall intrabony defects at different time intervals. Secondary objective To compare the clinical parameters and bone fill of bioactive calcium phospho-silicate graft and calcium phospho-silicate graft with enamel matrix derivative in the treatment of three wall intrabony defects at different time intervals.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • Inclusion criteria
  • Patients in the age group of 18-45 years.
  • Patients with probing pocket depth > 6 mm and clinical attachment level > 8 mm.
  • Patients with three wall intrabony defects in mandibular posterior teeth.
  • Patients willing to keep appointments.
  • Exclusion criteria
  • Patients on medication for systemic diseases.
  • Patients undergone regenerative periodontal therapy last 6 months.
  • Patients on antibiotics and non-steroidal anti-inflammatory analgesic therapy in last 3 months.
  • Test and control sites involving caries and any kind of prosthesis.
  • Pregnant and lactating females.
  • Patients with history of allergy to synthetic grafts and EMD.
  • Patients refusing to give consent for EMD.
  • Patients using any form of tobacco.

排除标准

  • Inclusion criteria
  • Patients in the age group of 18-45 years.
  • Patients with probing pocket depth > 6 mm and clinical attachment level > 8 mm.
  • Patients with three wall intrabony defects in mandibular posterior teeth.
  • Patients willing to keep appointments.
  • Exclusion criteria
  • Patients on medication for systemic diseases.
  • Patients undergone regenerative periodontal therapy last 6 months.
  • Patients on antibiotics and non-steroidal anti-inflammatory analgesic therapy in last 3 months.
  • Test and control sites involving caries and any kind of prosthesis.
  • Pregnant and lactating females.
  • Patients with history of allergy to synthetic grafts and EMD.
  • Patients refusing to give consent for EMD.
  • Patients using any form of tobacco.

结局指标

主要结局

Primary- There is no difference seen in clinical parameters and bone fill levels in patients with or without graft placement.

时间窗: Baseline, 3 month, 6 month

次要结局

  • Clinical parameters like gingival index, plaque index, probing depth, clinical attachment level & radiographic assessment will be done at baseline & at 6 months

研究者

发起方
Dr Anjali Batra
申办方类型
Other [Self Funded ]

研究点 (1)

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