Impact of Vitamin D Insufficiency and Type II Diabetes Mellitus on Periapical Lesions: A Comparative Study

Phase 3

Not yet recruiting

Conditions: Type 2 diabetes mellitus with unspecified complications, (2) ICD-10 Condition: E559||Vitamin D deficiency, unspecified,

Registration Number: CTRI/2025/05/087830

Lead Sponsor: Institute Of Dental Sciences Bhubaneswar

Brief Summary: **AIM** - **To evaluate theprevalence and the healing outcome of periapical lesions in patients withvitamin D insufficiency, Diabetes Mellitus type II or both**

**INTRODUCTION-**

Endodontic treatment is a treatment of choice in a number of cases withpulp necrosis and periapical infection but the healing might be influenced dueto presence of systemic condition or factors. Type II Diabetes Mellitus is asystemic metabolic disorder which even leads to an impaired immune systemleading to increased susceptibility to tissue breakdown and progress along withdelayed healing. 1,25(OH)D3 plays amajor role in immunity and breakdown of endotoxins which if deficient may leadto its impairment. Vitamin D insufficiency is related to increased insulinresistance and can even lead to death of beta cells of pancreas. Hencecorelated.

**MATERIAL AND METHODOLOGY-**

The patients attending the OPDdepartment of Institute of Dental Sciences and Department of Endocrinology willbe evaluated who have vitamin D insufficiency, diabetes mellitus type II orboth. After taking the consent, patients will be divided among the groups.Orthopantamographs will be used for overall estimation of dental status andperiapical status. Further in required cases, endodontic therapy will becarried out and post-endodontic healing evaluation of periapical lesion will bedone in accordance to PAI score (Periapical index scoring). Comparison will bedone among the groups regarding the prevalence and periapical healing.

**STATISTICAL ANALYSIS**-

Thecategorical variables will be analyzed using frequency distribution procedureand their association with groups will be studied using cross tabulationprocedure and Chi-square test of association. Scale variables like HbA1c, CBC,Lipid Profile, fasting blood sugar and Vitamin D levels will be analyzed usingdescriptive statistics procedure. Comparison of mean of scale variables amonggroups will be done following parametric one-way analysis of variance (ANOVA)or nonparametric Kruskal-Wallis test depending upon the nature of distributionsof the population as to the normality. The cut off significant probability willbe taken as less than 0.05.

**EXPECTED OUTCOME – Prevalence ofperiapical lesions is expected to increase and periapical healing rate isexpected to be increased in patients with vitamin D insufficiency and Type IIDiabetes Mellitus.**

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 480

Inclusion Criteria

Patients with Diabetes Mellitus type II or vitamin D deficiency visiting Department of Endocrinology, SUM Hospital and Institute of Dental Sciences, Bhubaneswar Patients requiring endodontic intervention or other dental care Patients aging 20 to 80 yrs old.

Exclusion Criteria

Patients with other systemic conditions that can have an effect on disease progression Patients on antibiotics, anti-inflammatory drugs within last 3 months Uncooperative patients Pregnant women Patients with physical disabilities.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the prevalence of periapical lesions in patients with vitamin D deficiency, Type II Diabetes Mellitus with that of patients without systemic condition	At time of reporting since for primary outcome only prevalence is being considered

Secondary Outcome Measures

Name	Time	Method
To compare the rate of healing in patients with vitamin D deficiency, Diabetes Mellitus with that of patients without systemic conditions.	at 1 month, 3 months, 6 months

Trial Locations

Locations (1): Institute of Dental Sciences and SUM hospital
🇮🇳
Khordha, ORISSA, India
Institute of Dental Sciences and SUM hospital
🇮🇳Khordha, ORISSA, India
Dr Arpita Patangia
Principal investigator
9692241222
arpita.patangia13@gmail.com