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Clinical Trials/CTRI/2024/12/078709
CTRI/2024/12/078709Not yet recruitingNot Applicable

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 site in 1 country60 target enrollmentStarted: January 9, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Evaluation and correlation of periodontal inflamed surface area in periodontitis patients with type 2 diabetes mellitus

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant Blinded

Eligibility Criteria

Ages
30.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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%.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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

Time Frame: At baseline.

Secondary Outcomes

  • 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)

Investigators

Sponsor
Sphoorthi Anup Belludi
Sponsor Class
Other [Self sponsored]
Responsible Party
Principal Investigator
Principal Investigator

Sphoorthi Anup Belludi

KLES Institute of Dental Sciences

Study Sites (1)

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