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临床试验/CTRI/2023/08/057143
CTRI/2023/08/057143进行中(未招募)3 期

Comparative evaluation of Platelet Rich Fibrin (PRF) and Titanium-Platelet Rich Fibrin (T-PRF) in the Treatment of Intrabony defects using 1% Metformin gel - A Clinical Study.

Raaja Sreepathy CS1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2023年10月9日最近更新:

试验速览

阶段
3 期
状态
进行中(未招募)
发起方
入组人数
26
试验地点
1
主要终点
3. GML – Gingival Marginal Level

研究概览

简要总结

The aim of the present study is to compare the clinical and radiographic success rate of PRF and TPRF  using 1% Metformin gel in Intrabony Defects among chronic Periodontitis patients of 30 to 60 years of age. A total sample of 26 sites will be selected according to the following inclusion and exclusion criteria or selection parameters: INCLUSION CRITERIA: 1.•Apparently healthy individuals.•Presence of Intrabony defect (IBD) depth ≥3 mm and interproximal probing depth (PD) ≥5 mm after phase I therapy.

EXCLUSION CRITERIA: â€¢HISTORY OF: Aggressive Periodontitis. Smoking and tobacco use. Systemic conditions are known to affect the periodontal status. Medications are known to affect the gingival condition. Pregnant or lactating women. Hematological disorders and insufficient platelet count after re-evaluation of Phase I therapy. The selected samples will be randomized into two groups with 13 samples each. Under local anesthesia access Flap will be reflected. Root planing, Debridement, and root biomodification will be done. Blood will be drawn from systemically healthy patients and will be centrifuged in desired RPM. Based on the test and control group; PRF AND T-PRF MIXED WITH 1% METFORMIN GEL will be placed in the defect site respectively. The flap will be approximated and sutured, periodontal dressing will be given. Post-operatively patients will be prescribed appropriate analgesics and antibiotics for 5 days and OHI will be reinforced. Both the groups will be followed up for the assessment of clinical and radiographic parameters at 0,3,6 months intervals. The above-obtained data will be statistically analyzed.

研究设计

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

入排标准

年龄范围
30.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1.Apparently healthy individuals.
  • Presence of Intrabony defect (IBD) depth ≥3 mm and interproximal probing depth (PD) ≥5 mm after phase I therapy.

排除标准

  • HISTORY OF : Aggressive Periodontitis.
  • Smoking and tobacco use.
  • Systemic conditions known to affect the periodontal status.
  • Medications known to affect the gingival condition
  • Pregnant or lactating women.
  • Hematological disorders and insufficient platelet count after re-evaluation of Phase I therapy.

结局指标

主要结局

3. GML – Gingival Marginal Level

时间窗: Baseline, 3 months and 6 months

clinical outcome assessment.

时间窗: Baseline, 3 months and 6 months

2. RAL- Relative Attachment Level

时间窗: Baseline, 3 months and 6 months

1. PD- Probing Depth

时间窗: Baseline, 3 months and 6 months

次要结局

  • radiographic parameters(1. Level of alveolar crest)

研究者

发起方
Raaja Sreepathy CS
申办方类型
Other [self]

研究点 (1)

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