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临床试验/CTRI/2025/08/092876
CTRI/2025/08/092876尚未招募1/2 期

Effect of scaling and root planning On the expression of neuregulin-4 Levels and its receptor erbb4 in gcf in Stage ii periodontitis patients with And without type 2 diabetis mellitus.

Sai pragathi1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2025年8月29日最近更新:

试验速览

阶段
1/2 期
状态
尚未招募
发起方
入组人数
45
试验地点
1
主要终点
change in neuregulin 4 levels in GCF

研究概览

简要总结

Written informed consent will be obtained from the patients who are fulfilling the inclusion

and exclusion criteria. All the clinical parameters will be recorded at baseline and 3 months

after SRP. Patients in groups 1,2 and 3 will receive periodontal therapy in the form of SRP

along with oral hygiene instructions (OHI) immediately after the baseline. GCF samples will

be collected from the patients at 24-72 hrs after baseline and 3 months after SRP. Neuregulin 4

levels will be measured by ELISA method using commercially available kit.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

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

入选标准

  • GROUP 1:Presence of minimum 16 natural teeth.
  • Systemically healthy patients with no signs of gingival inflammation defined by gingival index score<0.5 and without periodontal clinical attachment loss and bone loss.
  • group2: Systemically healthy patients with periodontitis clinically diagnosed based on American Academy Periodontology (2017) classification 7 having clinical attachment loss greater than or equal to 3mm in thirty percent of the sites and probing pocket depth greater than or equal to4 mm with at least 2 teeth.
  • group 3: Periodontitis patients (based on American Academy Periodontology 2017 classification) 7 with well controlled T2DM Patients with type 2 diabetes diagnosed at-least one year prior to the study using diagnostic criteria of the American Diabetes Association.

排除标准

  • Patients with any other systemic disease accompanying type 2 DM.
  • Patients with type 1 DM.
  • Pregnancy or lactation.
  • Current or former smokers.
  • Patients with history of periodontal therapy within past 6 months.
  • Patients with history of anti-inflammatory drug therapy within 3 months.
  • Patients with any intra oral lesions.

结局指标

主要结局

change in neuregulin 4 levels in GCF

时间窗: baseline,3 months

次要结局

  • change in periodontal parameters,corelatin between neuregulin 4 and diabetes mellitus(baseline, 3 months)

研究者

发起方
Sai pragathi
申办方类型
Other []
责任方
Principal Investigator
主要研究者

Dr Sai Pragathi

Vydehi institute of dental sciences and research centre

研究点 (1)

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