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临床试验/CTRI/2025/05/086832
CTRI/2025/05/086832尚未招募不适用

Estimation of Salivary volatile organic compounds in hypertensive subjects with periodontitis using Gas chromatography- Mass Spectrometry

Manav Rachna Dental college1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年5月19日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
试验地点
1
主要终点
The present study is undertaken to facilitate investigation to clarify the

研究概览

简要总结

Saliva is non-invasive and easily accessible fluid. It consist of volatile and non-volatile organic compounds responsible for the breath malodour. Halitosis/Breath malodour is an unpleasant smell from oral cavity.This originates from volatile sulphur compounds especially hydrogen sulphide, methyl mercaptan. Proteolytic degradation of sulphur and non sulphur containing amino acids by oral microorganisms in saliva, leads to release of malodorous compounds. The volatile organic compounds such as 1-Tetradecanol, 1-Hexadecanol, Toluene, Butylated hydroxytoluene and Dotriacontane are the products detected in saliva, breath and tongue-coating samples which is responsible for oral malodor. These compounds which are responsible for oral malodour are not observed in published studies in hypertensive patients with periodontitis because of difficulty in identification and quantification leading to exhaustive laboratory procedures. The putative pathogens responsible for periodontal disease are considered to be the prime causative factors for production of VOC causing oral malodour. Considering that periodontitis and hypertension share common risk factors,  the confounding factors must be controlled when assessing the association of these outcomes. Given the lack of published studies that have investigated the quantity of oral malodourous compounds in hypertensive subjects with or without periodontitis,this study is undertaken to evaluate malodourous compounds hypertensive patients with periodontitis. The subjects for the study will be selected from OPD in the Department of Periodontology, Manav Rachna Dental College, Faridabad. Selected subjects will be divided into 3 groups Group A, Group B and Group C based on hypertension and periodontal status. Group A consisting of Pre-Hypertensive  subjects with periodontitis, Group B comprising of Stage I Hypertensive periodontitis subjects  and Group C with Stage II Hypertensive periodontitis subjects .  All groups will undergo non-surgical periodontal therapy, recording of clinical parameters and saliva collection at baseline and at 1month. 3ml of unstimulated saliva will be collected by suction method and will be transferred to Eppendorf tubes. It will be stored at -80 degree centigrade till analysis. The Volatile organic compounds will be detected in saliva through the Gas chromatography- Mass spectrometry  analysis.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Outcome Assessor Blinded

入排标准

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

入选标准

  • Group A Pre-Hypertensive periodontitis subjects 1.Generalised periodontitis 2.Age between 30 to 60 years 3.Bleeding on probing <10% 4.Pre-hypertension subjects according to AHA classification 5.Patient willing to participate in the study Group B- Stage I Hypertensive periodontitis subjects
  • Generalized periodontitis
  • Age between 30 to 60 years 3.Stage I Hypertension according to AHA guidelines 4.Patient willing to participate in the study Group C- Stage II Hypertensive periodontitis subjects
  • Age between 30 to 60 years
  • Stage II hypertension according to AHA guidelines 4.Patient willing to participate in the study.

排除标准

  • Periodontal therapy last 3 months.
  • Antibiotics in last 3 months.
  • Pregnant and lactating females.
  • Subjects using any form of tobacco.
  • History of nasal obstructions and mouth breathers
  • History of known systemic diseases except hypertension
  • History of use of mouthwashes
  • Subjects using Dental prosthesis.

结局指标

主要结局

The present study is undertaken to facilitate investigation to clarify the

时间窗: The recording of clinical parameters , saliva collection and estimation of volatile sulphur compounds measurement with the help of GC-MS at baseline and 1 month

role of volatile organic compounds measurement with the help of GC-MS in causing oral

时间窗: The recording of clinical parameters , saliva collection and estimation of volatile sulphur compounds measurement with the help of GC-MS at baseline and 1 month

malodour in obese hypertensive subjects with and without periodontitis.

时间窗: The recording of clinical parameters , saliva collection and estimation of volatile sulphur compounds measurement with the help of GC-MS at baseline and 1 month

次要结局

  • To compare the salivary VOC levels and clinical parameters in(hypertensive with periodontitis subjects among all groups using GC-)

研究者

申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Lipika Gopal

manav rachna dental college

研究点 (1)

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