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临床试验/CTRI/2025/02/080543
CTRI/2025/02/080543已完成4 期

Comparison of salivary ph, alkaline phosphatase, lectate dehydrogenase, amylase, calcium, sodium and magnesium among healthy gingiva, periodontitis with and without smoking

Dharmsinh Desai University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年2月20日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Salivary Biomarkers- Salivary pH, alkaline phosphatase, lactate dehydrogenase, amylase, calcium, sodium and magnesium

研究概览

简要总结

This study shall compare the salivary biomarkers among healthy gingiva, periodontitis with and without habit of smoking. It will be conducted as a clinical trial involving 60 patients with healthy gingiva, periodontitis with and without habit of smoking who meet the specified inclusion criteria. Various biochemical investigations including salivary pH, alkaline phosphatase, lactate dehydrogenase, amylase, calcium, sodium and magnesium levels among healthy gingiva, periodontitis with and without habit of smoking will be recorded at baseline and 1 month. The research aims to evaluate and compare the levels of salivary pH, alkaline phosphatase, lactate dehydrogenase, amylase, calcium, sodium and magnesium levels among healthy gingiva, periodontitis with and without habit of smoking. This salivary biomarkers will act as diagnostic biomarkers for estimating level of inflammatory diseases. The findings will contribute to improving clinical decision making and providing dentists with evidence based recommendations for treatment planning.

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
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Age group between 18 – 60 years.
  • Minimum 15 natural teeth should be present in dental arch excluding 3rd molar.
  • The periodontally healthy individuals will be selected on the basis of probing depth of less than equal to 3mm, with no radiographic evidence of alveolar bone loss and attachment loss and no bleeding on probing.
  • Generalised periodontitis individuals who has consumed more than five cigarettes a day since past 5 years will be selected on the basis of probing depth of greater than equal to 5mm with a minimum of eight teeth, clinical attachment loss with or without bleeding on probing and having moderate bone loss on an ortho-pantomogram (OPG).
  • Generalised periodontitis individuals who has never smoke any cigarettes will be selected on the basis of probing depth of grater than equal to 5mm with a minimum of eight teeth, clinical attachment loss with or without bleeding on probing and having moderate bone loss on an ortho-pantomogram (OPG).

排除标准

  • Other form of tobacco users.
  • Smokers who have quite the habit of smoking in the last 6 months.
  • History of hospitalization or intake of medications in last 6 months.
  • Previous history of periodontal therapy in last 6 months.

结局指标

主要结局

Salivary Biomarkers- Salivary pH, alkaline phosphatase, lactate dehydrogenase, amylase, calcium, sodium and magnesium

时间窗: Baseline, and 1 Month

次要结局

  • Probing Depth, Plaque Index, Gingival Index, Clinical Attachment Level(Baseline and 1 Month)

研究者

发起方
Dharmsinh Desai University
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Krunal Parmar

Faculty of Dental sciences, Dharmsinh Desai University

研究点 (1)

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