| CTRI Number |
CTRI/2025/05/087830 [Registered on: 28/05/2025] Trial Registered Prospectively |
| Last Modified On: |
16/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Impact of Vitamin D Insufficiency and Type II Diabetes Mellitus on Periapical Lesions: A Comparative Study |
|
Scientific Title of Study
|
Prevalence and periapical healing outcome in patients with Vitamin D insufficiency, Type II Diabetes mellitus or both: a comparative study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arpita Patangia |
| Designation |
Post graduate trainee |
| Affiliation |
Institute Of Dental sciences, Bhubaneswar |
| Address |
Room no. 7, 2nd floor, Institute Of Dental sciences,
Siksha O Anusandhan University,
k8, Kalinga Nagar
Khordha
ORISSA
751003
India |
| Phone |
9692241222 |
| Fax |
|
| Email |
arpita.patangia13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Lora Mishra |
| Designation |
Professor and Systematic review coordinator |
| Affiliation |
Institute Of Dental sciences, Bhubaneswar |
| Address |
Room no 7, 2nd floor, Institute Of Dental sciences,
Siksha O Anusandhan University,
k8, Kalinga Nagar
Khordha
ORISSA
751003
India |
| Phone |
8895266363 |
| Fax |
|
| Email |
loramishra@soa.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Arpita Patangia |
| Designation |
Post graduate trainee |
| Affiliation |
Institute Of Dental sciences, Bhubaneswar |
| Address |
Room no. 7, 2nd floor, Institute Of Dental sciences,
Siksha O Anusandhan University,
k8, Kalinga Nagar
Khordha
ORISSA
751003
India |
| Phone |
9692241222 |
| Fax |
|
| Email |
arpita.patangia13@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute Of Dental Sciences and SUM Hospital, Bhubaneswar - 751003, Odisha |
|
|
Primary Sponsor
|
| Name |
Institute Of Dental Sciences Bhubaneswar |
| Address |
Institute of Dental Sciences, K8, Kalinga Nagar 751003,
Bhubaneswar, Odisha |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arpita Patangia |
Institute of Dental Sciences and SUM hospital |
Institute Of Dental Sciences,
Siksha O Anusandhan University,
K8, Kalinga Nagar,
Bhubaneswar
Institute Of Dental Sciences,
Siksha O Anusandhan University,
K8, Kalinga Nagar,
Bhubaneswar - 751003
Khordha
ORISSA |
9692241222
arpita.patangia13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC - INSTITUTE OF DENTAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, (2) ICD-10 Condition: E559||Vitamin D deficiency, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Patients without vitamin D insufficiency, type II Diabetes Mellitus or any other systemic condition |
Comparison to be made between prevalence of periapical lesions in patients with Type II Diabetes Mellitus, Vitamin D Insufficiency or patients with both vitamin D insufficiency and type II Diabetes Mellitus
Comparison to be made between healing rate of the above mentioned groups. |
| Intervention |
Vitamin D Insufficiency and Type II Diabetes Mellitus |
Patients to be checked for prevalence of periapical lesion in cases with type II Diabetes Mellitus of vitamin D deficiency followed by root canal treatment and follow up for evaluation of periapical healing rate which can differ in patients with nutritional vitamin D deficiency or endocrine disorder. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
| 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 |
|
|
Target Sample Size
|
Total Sample Size="480"
Sample Size from India="480"
Final Enrollment numbers achieved (Total)= "473"
Final Enrollment numbers achieved (India)="473" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/06/2025 |
| Date of Study Completion (India) |
30/11/2025 |
| Date of First Enrollment (Global) |
10/06/2025 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Study under process |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
AIM - To evaluate the prevalence and the healing outcome of periapical lesions in patients with vitamin D insufficiency, Diabetes Mellitus type II or both INTRODUCTION- Endodontic treatment is a treatment of choice in a number of cases with pulp necrosis and periapical infection but the healing might be influenced due to presence of systemic condition or factors. Type II Diabetes Mellitus is a systemic metabolic disorder which even leads to an impaired immune system leading to increased susceptibility to tissue breakdown and progress along with delayed healing. 1,25(OH)D3 plays a major role in immunity and breakdown of endotoxins which if deficient may lead to its impairment. Vitamin D insufficiency is related to increased insulin resistance and can even lead to death of beta cells of pancreas. Hence corelated. MATERIAL AND METHODOLOGY- The patients attending the OPD department of Institute of Dental Sciences and Department of Endocrinology will be evaluated who have vitamin D insufficiency, diabetes mellitus type II or both. After taking the consent, patients will be divided among the groups. Orthopantamographs will be used for overall estimation of dental status and periapical status. Further in required cases, endodontic therapy will be carried out and post-endodontic healing evaluation of periapical lesion will be done in accordance to PAI score (Periapical index scoring). Comparison will be done among the groups regarding the prevalence and periapical healing. STATISTICAL ANALYSIS- The categorical variables will be analyzed using frequency distribution procedure and their association with groups will be studied using cross tabulation procedure and Chi-square test of association. Scale variables like HbA1c, CBC, Lipid Profile, fasting blood sugar and Vitamin D levels will be analyzed using descriptive statistics procedure. Comparison of mean of scale variables among groups will be done following parametric one-way analysis of variance (ANOVA) or nonparametric Kruskal-Wallis test depending upon the nature of distributions of the population as to the normality. The cut off significant probability will be taken as less than 0.05. EXPECTED OUTCOME – Prevalence of periapical lesions is expected to increase and periapical healing rate is expected to be increased in patients with vitamin D insufficiency and Type II Diabetes Mellitus. |