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临床试验/CTRI/2024/11/077256
CTRI/2024/11/077256尚未招募不适用

Effect of full mouth disinfection on salivary melatonin levels and tannerella forsythia in chronic periodontitis patients: a clinical, biochemical and microbiological study.

Cheppalli Naga Pranavi1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年12月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Salivary melatonin levels, tannerella forsythia

研究概览

简要总结

Periodontitis is described as an inflammatory process, initiated by plaque biofilm that leads to loss of periodontal attachment to the root surface and adjacent alveolar bone which ultimately results in bone loss. The inflammatory and immune responses to the bacteria that colonize the periodontal and associated tissue creates a bidirectional series of host- microbial interactions. While the primary etiologic agent is predominantly gram-negative bacteria within the sub gingival biofilm, the majority of periodontal tissue destruction is caused by an inappropriate host response to those microorganisms and their products more specifically a loss of homeostatic balance between proteolytic enzymes and their inhibitors and reactive oxygen species and the antioxidant defence systems resulting in generation of free radicals leading to decrease in the anti- oxidant defence.

One such microorganisms which is recognized as microbial pathogen implicated in the development of periodontal disease by inducing loss of homeostatic balance and resulting in generation of free radicals is Tannerella forsythia. It is a gram-negative anaerobic rod with tapered ends, described as fusiform bacteroides in one of the culture report of progressing advanced periodontitis. The search is on to investigate the pathological potential of various bacteria responsible for periodontal diseases. Past difficulties with identification and culture of Tannerella forsythia have probably been the main reasons why this organism has not been as extensively studied as other putative periodontal pathogens.

Melatonin is an indoleamine hormone produced by the pineal gland that governs the human body’s circadian rhythm and biological clock, plays an important role in the control of periodontal disease due to its significant anti-inflammatory and anti-oxidant property by directly neutralizing the highly destructive reduced oxygen species generated by oxygen derived free radicals. And it can also block reduced oxygen species produced by the superoxide dismutase therefore playing an important role in regulatory bone resorption process. It has ability to bind metals suppresses bacteria development in invitro which is linked to periodontitis. Melatonin levels can fluctuate in periodontitis due to oxidative stress and bacterial invasion caused by loss of homeostatic balance between proteolytic enzymes and their inhibitors.

Full mouth disinfection is one of the nonsurgical treatment options for periodontitis, in which the bacterial biofilm is removed, reducing the bacterial burden and hence the rate of formation of free radicals.

Saliva as a mirror of oral and systemic health is a valuable source of clinically relevant information because it contains biomarkers and also bacteria specific for the unique physiologic aspects of periodontal disease. Hence interest in saliva as a diagnostic and a medium for prognosticate periodontal treatment outcomes in escalating due to its advantages over other diagnostic biofluids as it is readily available which makes the collection process   fairly straight forward with no potential for cross contamination.

Although the potential therapeutic effect  of melatonin in periodontitis has been well documented in various in vitro, animal studies and clinical trials, the relation ship between the periodontal status and the influence of periodontal treatment on salivary melatonin and levels of Tannerella forsythia in saliva is still conclusive, the present study was aimed to evaluate the effect of full mouth disinfection on salivary melatonin levels of Tannerella forsythia in saliva in patients with chronic periodontitis and also to explore the possible correlations between clinical parameters, salivary melatonin levels and levels of Tannerella forsythia in saliva.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • For group A (healthy periodontium): Subjects with age group: 25-50 years both males and females.
  • Individuals having 20 teeth or more.
  • Systemically healthy participants.
  • Intact periodontium with BOP less than 10% and PD less than or equal to 3mm without clinical attachment loss or radiographic sign of alveolar bone destruction.
  • For group B (chronic periodontitis): Chronic periodontitis with CAL greater than or equal to 2 mm, PD greater than or equal to 5 mm and radiographic bone loss extending to the mid-third of the root or beyond.

排除标准

  • Patients with any systemic diseases.
  • Patients taking medication affecting periodontal health.
  • Patients who have undergone periodontal therapy in the past 6 months.
  • Pregnant and lactating women.
  • Participants with xerostomia.
  • Smokers and Tobacco users.

结局指标

主要结局

Salivary melatonin levels, tannerella forsythia

时间窗: Baseline, 3 months

次要结局

  • Clinical parameters plaque index, gingival index, probing pocket depth, clinical attachment level and bleeding on probing(Baseline and 3 months)

研究者

发起方
Cheppalli Naga Pranavi
申办方类型
Other [Self sponsored]
责任方
Principal Investigator
主要研究者

Dr Cheppalli Naga Pranavi

Sri Rajiv Gandi College of Dental Sciences and Hospital

研究点 (1)

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