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临床试验/CTRI/2024/06/068754
CTRI/2024/06/068754尚未招募2/3 期

Evaluation and Co-relation of Macrophage Inflammation Protein (MIP-1α) in Gingival Crevicular Fluid (GCF) of patients suffering from Chronic Periodontitis, treated with Open Flap debridement with and without Platelet rich Fibrin- A Split-Mouth Randomized Controlled Clinical Trial.

ITS Dental College Hospital and Research Centre Greater Noida1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年7月1日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
1. Plaque Index (PI)- Silness and Loe(1964)

研究概览

简要总结

This study holds significance in the field of periodontics due to its potential to address critical gaps in understanding the inflammatory response in chronic periodontitis treatment. Chronic periodontitis is a prevalent inflammatory condition affecting the supporting structures of teeth, where the role of inflammatory mediators like Macrophage Inflammation Protein-1α (MIP-1α) remains pivotal. The tenet for the study is to assess and estimate the levels of MIP-1α, an inflammatory marker in patients treated with Open flap debridement (OFD) with and without Platelet- rich Fibrin (PRF). MIP-1α is a known biomarker which increases in cases of inflammatory reaction. OFD is a classical and effective treatment modality for reducing pocket probing depth and when combined with an autologous biomimetic material such as PRF; which is rich in various growth factors and is known to accelerate wound healing and reduces inflammation. Therefore this study is undertaken for better understanding of the role of PRF along with OFD by evaluating and assessing the levels of MIP-1α of a potent biomarker such as Macrophage Inflammatory Protein- 1 Alpha (MIP-1α).

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
21.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Chronic periodontitis patients with Probing depth- ≥ to 4mm and ≤ 7mm (AAP Classification 2017).
  • Presence of at least ≥ to 20 natural teeth in both upper and lower arches.

排除标准

  • Subjects using smoked and smokeless tobacco.
  • Pregnant and lactating females.
  • Subjects with history of uncontrolled systemic diseases affecting the periodontium.
  • Subjects allergic to medications prescribed during treatment.
  • Subjects who have received surgical or non- surgical periodontal therapy 6 months prior.
  • Post-menopausal women.

结局指标

主要结局

1. Plaque Index (PI)- Silness and Loe(1964)

时间窗: Measured at 0, 3 and 6 months

2. Gingival Index (GI)- Loe and Silness (1963)

时间窗: Measured at 0, 3 and 6 months

3. Bleeding Index (BI)- Ainamo and Bay (1975)

时间窗: Measured at 0, 3 and 6 months

4. Relative Pocket Probing Depth (PPD)

时间窗: Measured at 0, 3 and 6 months

5. Wound healing Index (WHI)- (Landry et. al. 1988)

时间窗: Measured at 0, 3 and 6 months

6. Relative Attachment Level (RAL)

时间窗: Measured at 0, 3 and 6 months

7. ELISA for biomarker

时间窗: Measured at 0, 3 and 6 months

次要结局

  • Phenotype for gingiva(Measured at 0, 3 and 6 months)

研究者

发起方
ITS Dental College Hospital and Research Centre Greater Noida
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Arunima Bansal

ITS Dental College Hospital and Research Centre, Greater Noida

研究点 (1)

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