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临床试验/NCT04788979
NCT04788979Unknown1 期

The Adjunctive Use of Systemic Melatonin Therapy in the Treatment of Periodontitis Associated With Obesity (Clinical and Immunological Study).

University of Baghdad1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年4月1日最近更新:
适应症
相关药物

试验速览

阶段
1 期
入组人数
80
试验地点
1
主要终点
measurement of clinical periodontal parameters

研究概览

简要总结

To evaluate the effect of adjunctive systemic administration of melatonin to mechanical non- surgical periodontal therapy in obese patients with periodontitis.

详细描述

Periodontitis defined as destruction of periodontal tissue caused by specific microorganisms resulting of pocket formation, recession and mobility.Obesity known to increase the host tolerance by influencing the immune and inflammatory mechanisms in a way that inflammatory tissue destruction is predisposed and leave a person at high risk of developing periodontitis.the relationship between periodontitis and obesity has been reported in several epidemiological and experimental studies.

Obesity can be a higher trigger of chronic stress , stress and how a person copes with stress has been shown to increase the risk of periodontitis.several studied have shown that preserving of normal weight by maintaining regular physical exercise is linked with a lower incidence of periodontitis.

As a matter of truth , overweight and obese individuals are more than twice as likely to have periodontitis compared to normal healthy persons. It has been suggested that obesity decreased the blood flow to periodontal tissue, enabling the development of periodontal disorders. The blood vessels of obese subjects demonstrate a thickening in the inner wall of arteries that reduce the flow of blood into periodontium. The adipocytes produce various active molecules called adipokines involving (TNF- α, IL-6, leptin, adiponectin and others). These compound secrete various molecules of reactive oxygen species (ROS) that lowered antioxidant enzymes activity like (superoxide dismutase, catalase, glutathione and others). Thus modulating the effect of adipokines can lower the pathogenicity of periodontitis by reducing the effect of oxidative stress.

Oxidative stress appear to be the main link between obesity and periodontitis and can aggravates pro-inflammatory pathways frequent in both pathologies. Regarding the significance of oxidative stress in pathologies of both periodontitis and obesity, several antioxidants play an amazing role as a preventive and therapeutic measures for both diseases. Multiple studies had a greater evidence toward melatonin which have an active antioxidant properties , which is an indolamine produced mainly by pinealocytes. It has been documented that salivary melatonin were significantly decreased in patients with periodontal disease, indicated that melatonin may act as a biomarker for periodontal diagnosis and can be used as a possible therapeutic agent in various periodontal diseases.

It is indicated that adjunctive use of melatonin in combination with non-surgical scaling and root planning for 3 weeks can lead to improvement of clinical periodontal parameters in diabetic patients. It was demonstrated that daily dietary supplementation with 3mg melatonin tablet for 4 weeks along with scaling and root planning significantly reduced the oxidative stress in periodontitis patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

盲法说明

self investigator

入排标准

年龄范围
27 Years 至 54 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • The study involve three groups: the first one is control (healthy normal weight group).
  • The second one is experimental group which must have the following criteria:
  • 1-latest sleep, obese patients diagnosed to have periodontitis with probing pocket depth ≥ 5mm, 2-patients able to follow the required instruction.

排除标准

  • 1-individuals having night work shifts. 2-patients wearing removable partial dentures and undergoing orthodontic treatment.
  • 3-patient taking anti-inflammatory drugs, antibiotics, immunosuppressant or oral contraceptives since last 3 months.
  • 4-paients with diabetic mellitus, liver diseases, autoimmune diseases and osteoporosis.
  • 5-pregnant or lactating women. 6-cancer patient. 7-smoker patient.

结局指标

主要结局

measurement of clinical periodontal parameters

时间窗: 4 weeks

1. plaque index 2. gingival index 3. bleeding on probing 4. pocket depth 5. relative attachment level all parameters are recorded by using periodontal probe.

measurement of biochemical markers in serum

时间窗: 4 weeks

1. measurement of receptor activator of nuclear KB receptor 2. measurement of total antioxidant capacity 3. measurement of melatonin level all markers are recorded by using Eliza

次要结局

  • measurement of lipid profiles in serum(4 weeks)
  • measurement of BMI(base line visit)

研究者

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

sami Hussam

Doctor

University of Baghdad

研究点 (1)

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