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临床试验/CTRI/2024/07/070634
CTRI/2024/07/070634尚未招募2/3 期

Comparative Evaluation of Serum Creatinine and Alkaline Phosphatase levels in Chronic Periodontitis Patients with and without Type 2 Diabetes Mellitus Before and After Scaling and Root Planing- A Clinico-biochemical Study

Dr Shruti Meshram1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2024年12月20日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
66
试验地点
1
主要终点
BIOCHEMICAL PARAMETERS

研究概览

简要总结

Aim and Objective

To evaluate and compare the serum creatinine and alkaline phosphatase levels in chronic periodontitis patients with and without T2DM.

Material and Methods

The patients selected as per the inclusion and exclusion criteria, will be allotted into 3 groups, Group A, Group B and Group C

Group A : 22 Periodontally and systemically healthy patients

Group B : 22 Chronic periodontitis patients without T2DM

     Group C : 22 Chronic  periodontitis patients with T2DM

After initial examination and taking informed consent from the patient 2ml blood with be taken followed by scaling and root planing  o the patient and blood sample will be sent to assess the serum ALP and creatinine levels.

The patient will be recalled after 4 weeks , after reviewing the periodontal status 2 ml of blood sample will be taken to assess serum ALP and creatinine.

Data collected will be compiled on to a MS Office excel worksheet & will be subjected to statistical analysis using an appropriate package like SPSS software.

Normality of numerical data will be checked using Shapiro – Wilk test or Kolmogorov-Smirnov test. Depending on the normality of data, statistical tests will be determined.

For a numerical continuous data following a normal distribution, inter group comparison (>2 groups) will be done using one way ANOVA test, else a non parametric substitute like Kruskall Wallis ANOVA test will be used.

Descriptive statistics like frequency (n) & percentage (%) of categorical data, mean & Standard deviation of numerical data in each group will be depicted & may be compared using chi square test.

Keeping alpha error at 5% and Beta error at 20%, power at 80%, p<0.05 will be considered statistically significant.

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

入选标准

  • Group A: Periodontally healthy patients with no clinical gingival inflammation and GI equal to 0, probing depth (PPD) less than or equal to 3 mm, and no radiographic evidence of bone loss Group B: Chronic periodontitis patients without T2DM with GI greater than 1, PPD greater than or equal to 6mm and CAL greater than or equal to 5mm.
  • Group C: Chronic periodontitis patients with T2DM patients, GI greater than 1, PPD greater than or equal to 6mm and CAL greater than 5mm.
  • HbA1c levels between 5-7%.

排除标准

  • Patients who have undergone any periodontal therapy in the past 6 months.
  • Patients with symptoms of acute illness.
  • Patients who are on immunosuppressive therapy or having any other systemic illness.
  • 4 Systemic anti-inflammatory treatment within the previous 3 months or regular use of specific drugs known to affect periodontal tissues.
  • Pregnant women and lactating mothers.

结局指标

主要结局

BIOCHEMICAL PARAMETERS

时间窗: At baseline and after 4 weeks

1) Fasting plasma glucose (FPG)

时间窗: At baseline and after 4 weeks

3) HbA1c

时间窗: At baseline and after 4 weeks

2) Post Prandial plasma glucose (PPG)

时间窗: At baseline and after 4 weeks

4) Creatinine

时间窗: At baseline and after 4 weeks

5) Alkaline phosphatase

时间窗: At baseline and after 4 weeks

CLINICAL PARAMETERS

时间窗: At baseline and after 4 weeks

1.Plaque Index (P.I.) (Tureskey-Gilmore-Glickman Modification of Quigley Hein)

时间窗: At baseline and after 4 weeks

2.Gingival Index (G.I.) (Loe and Silness, 1963)

时间窗: At baseline and after 4 weeks

3.Probing Pocket Depth (PPD)

时间窗: At baseline and after 4 weeks

4.Clinical Attachment Level (CAL)

时间窗: At baseline and after 4 weeks

次要结局

  • serum Alkaline phosphatase and serum creatinine levels in normal people and in people suffering from type 2 diabetes mellitus(serum Alkaline phosphatase and serum creatinine levels before scaling and root planing and 4 weeks post scaling and root planing)

研究者

发起方
Dr Shruti Meshram
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Shruti Meshram

Nair hospital Dental College, Mumbai

研究点 (1)

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