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临床试验/CTRI/2024/12/078709
CTRI/2024/12/078709尚未招募不适用

Correlation of periodontal inflamed surface area with the effect of vitamin d supplement and low level laser therapy as an adjunct to scaling and root planing in periodontitis patients with type 2 diabetes mellitus and vitamin d insufficiency - a randomized controlled clinical trial

Sphoorthi Anup Belludi1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年1月9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
60
试验地点
1
主要终点
Evaluation and correlation of periodontal inflamed surface area in periodontitis patients with type 2 diabetes mellitus

研究概览

简要总结

Aim of the study is to evaluate and corelate periodontal inflamed surface area with the effect of Vitamin D supplement and low level laser therapy on HbA1c, serum Vitamin D levels and clinical parameters when used as an adjunct to scaling and root planing in non surgical management of Vitamin D insufficient stage 2 grade B or grade C periodontitis patients with type2 diabetes mellitus.

The study population will consist of individuals of both genders, in the age group of 30 to 65 years who volunteer to participate in the study and also fulfill the inclusion and exclusion criteria, all the subjects will recruited after providing the participants with an information sheet, explaining the purpose, nature and design of the study and obtaining a written informed consent from the subjects choose for the study. After thorough screening 60 subjects of both sexes satisfying the inclusion criteria and willing to participate in the study will be enrolled. The subjects will then be randomly and equally assigned using computerized randomization into 4 groups.  Group 1 consist of 15 subjects with grade b or grade C periodontitis DM2 and Vitamin D insufficiency will be subjected to scaling and root planing and low level laser therapy application and will be prescribed with Vitamin d supplement for once a week for 10 weeks, group 2 consist of 15 subjects will be subjected to scaling and low level laser therapy and placebo for once a week for 10 weeks,

group 3 consist of 15 subjects will be subjected to scaling, sham and Vitamin D supplement once a week for 10 weeks, group 4 consis of 15 subjected to scaling and root planing and will be subjected to sham and placebo. Then assessing clinical parameters, serum vitamin D level  and Hb1Ac at basline and 3 months after scaling and root planing in all 4 groups.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
30.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients with minimum of 20 teeth Patients with vitamin D insufficiency, stage 2, grade B or C periodontitis Patients with type 2 diabetes mellitus with HbA1c range between 6.0% to 8.0%.

排除标准

  • Patients who undergone periodontal therapy in the past 6 months.
  • Patients on immunosuppressant, antibiotics or any form of supplement therapy 6 months prior to study.
  • current smokers, alcoholics, smokeless tobacco users.
  • Pregnant and lactating women.
  • Post menopausal women.
  • Patients with acute illness/ acute intraoral lesions.
  • Subjects with chronic systemic disease other than type 2 diabetes mellitus.

结局指标

主要结局

Evaluation and correlation of periodontal inflamed surface area in periodontitis patients with type 2 diabetes mellitus

时间窗: At baseline.

次要结局

  • Evaluation & correlation of Vitamin D & Low level laser therapy with periodontal inflamed surface area in periodontitis patients with type 2 diabetes mellitus.(At 3 months)

研究者

发起方
Sphoorthi Anup Belludi
申办方类型
Other [Self sponsored]
责任方
Principal Investigator
主要研究者

Sphoorthi Anup Belludi

KLES Institute of Dental Sciences

研究点 (1)

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