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临床试验/CTRI/2013/05/003660
CTRI/2013/05/003660招募中3 期

Effect of non-surgical periodontal therapy on glycaemic control in type II diabetic patients: A randomized controlled clinical trial.

vaibhav tandon1 个研究点 分布在 1 个国家目标入组 100,000 人开始时间: 2013年3月25日最近更新:
适应症

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
100,000
试验地点
1
主要终点
Glycated Haemoglobin(HbA1c)in%

研究概览

简要总结

INTRODUCTION

Diabetesmellitus (DM) is a chronic, non-communicable disease and also one of the majorglobal public health issues. It is defined as a clinical syndrome characterizedby hyperglycemia due to the defect in insulin secretion by pancreatic β cells,decrease in insulin sensitivity, or a combination of both. The most common formof DM is Diabetes mellitus type 2 (DM2), which accounts for 85% of all diabetespatients.1 Periodontaldisease is the most prevalent oral complication in patients with type 2diabetes mellitus. Periodontitis is a disease characterized by periodontalpocket formation, loss of connective tissue attachment, alveolar boneresorption, and gingival inflammation, ultimately resulting in tooth loss.

The observation that periodontal therapy appears toreduce periodontal infection and inflammation, suggests that periodontaltherapy may facilitate metabolic control of diabetes, improving insulinsensitivity by reducing peripheral inflammatory cytokines levels.2 Therefore,we put on the hypothesis that if periodontitis is casually related to worseningof parameters of diabetic patients, then periodontal treatment should improveglycaemic control.

The aim of the study is to investigatethe effects of non- surgical periodontal therapy on glycaemic control in DM2patients.

METHODOLOGY

Convenientsample of 60 patients aged 35-45 years will be selected from a Diabetic Centrein Moradabad. Patient who came to Diabetic Centre for their routine check upand investigation will screen for type II Diabetes Mellitus and Periodontitis.

This study was revived and approved by theinstitutional Ethical Review Committee, Moradabad.

Theinclusion criteria include; Blood sugar controlled only with oral hypoglycaemicagents and no systemic antibiotic administration or periodontal treatmentwithin the last six months. The exclusion criteria includes; Patients  with systemic diseases other than DiabetesMellitus type II, tobacco and alcohol users and patients who were suffering from oral disease that need emergencytreatment like endo-perio lesion, periodontal abscess.

Theoral examination will be conducted in dental clinical wing of the diabetic centre.Oral examination includes assessing periodontal Pocket Depth, Gingival statusand Plaque accumulation of each individual patient. Periodontal pocket depthwas assessed by measuring Probing pocket depth(PPD) with UNC-15 probe at sixpoints for each tooth and the arithmetic mean value of all the teeth wasconsidered. Gingival status was assessed by Gingival Index, Loe & Silness(1963). Dental plaque was assessed by Plaque Index, Silness & Loe(1967).

Glycemicstatus will be assesses by the HbA1c and fasting blood sugar level.Participating subjects were interviewed for the demographic data, duration andthe frequency of a drug and were cross verified with the hospital records.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Investigator Blinded

入排标准

年龄范围
35.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • •Blood sugar controlled only with oral hypoglycaemic agents and no systemic antibiotic administration or periodontal treatment within the last six months.

排除标准

  • •Patients with systemic diseases other than Diabetes Mellitus type II, tobacco and alcohol users and patients who were suffering from oral disease that need emergency treatment like endo-perio lesion, periodontal abscess.

结局指标

主要结局

Glycated Haemoglobin(HbA1c)in%

时间窗: data will be recorded at baseline and after 3 months

次要结局

  • Probing Pocket Depth(PPD)in mm,(Plaque Index (PI) ,)

研究者

发起方
vaibhav tandon
申办方类型
Other [self]

研究点 (1)

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