| CTRI Number |
CTRI/2024/09/074335 [Registered on: 25/09/2024] Trial Registered Prospectively |
| Last Modified On: |
19/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Trial Comparing Preventive and Standard Methods of Dental Care for Improving Oral Health and Blood Sugar Control in Children with Type 1 Diabetes |
|
Scientific Title of Study
|
Effectiveness of Preventive Oral Healthcare Package Versus Conventional Method of Oral Healthcare on Oral Health Status and Glycemic Control among Children with Type 1 Diabetes Mellitus: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rashmi Misra |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Department of Public Health Dentistry, Maulana Azad Institute of Dental Sciences,
Bahadur Shah Zafar Marg,
New Delhi 110002
Central
DELHI
110002
India |
| Phone |
8076175436 |
| Fax |
|
| Email |
mishra.rashmi792@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikrant Mohanty |
| Designation |
Professor and Head of Department |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Department of Public Health Dentistry, Maulana Azad Institute of Dental Sciences,
Bahadur Shah Zafar Marg,
New Delhi 110002
Central
DELHI
110002
India |
| Phone |
9654700983 |
| Fax |
|
| Email |
vikrantmohanty@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmi Misra |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Department of Public Health Dentistry, Maulana Azad Institute of Dental Sciences,
Bahadur Shah Zafar Marg,
New Delhi 110002
Central
DELHI
110002
India |
| Phone |
8076175436 |
| Fax |
|
| Email |
mishra.rashmi792@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Public Health Dentistry, Maulana Azad Institute of Dental Sciences,
Bahadur Shah Zafar Marg,
New Delhi 110002 |
|
|
Primary Sponsor
|
| Name |
Rashmi Misra |
| Address |
Department of Public Health Dentistry, Maulana Azad Institute of Dental Sciences,
Bahadur Shah Zafar Marg,
New Delhi 110002 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Rashmi Misra |
Maulana Azad Institute of Dental Sciences |
Room no 504, 5th floor, Department of Public Health Dentistry, Maulana Azad Institute of Dental Sciences
Central
DELHI |
8076175436
mishra.rashmi792@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Institute of Dental Sciences, New Delhi (Govt. of NCT of Delhi) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K025||Dental caries on pit and fissure surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional method of oral healthcare |
Standard Dental Care including availability of all basic
dental procedures, oral urgent treatment for pain relief, along with conventional health
education regarding oral health care with tooth-brushing demonstration.
Duration of intervention- 12 months |
| Intervention |
Preventive Oral Healthcare Package |
Standard Dental Care + Preventive Oral Healthcare
Package including anticipatory guidance, health education animation video for
children, pamphlets for caregivers/parents, fluoride varnish application and pit and
fissure sealant placement (wherever indicated) along with conventional health
education regarding oral health care.
Duration of intervention- 12 months |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects of either sex between the age group of 6 to 14 years, diagnosed with Type 1 Diabetes Mellitus
2.Patient diagnosed with Type 1 Diabetes Mellitus for at least 6 months back |
|
| ExclusionCriteria |
| Details |
1.Patients with known history of any other systemic diseases
2.Presence of periapical pathological lesions
3.Patients who underwent dental treatment in the past 6 months
4.Presence of congenital dental disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in oral health status, oral hygiene practices and caries incidence (incipient
caries) in intervention group |
Assessments will be conducted at 1 month, 3 months and 6 months after implementation of Preventive Oral Healthcare Package |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement of glycemic levels in intervention group, changes in utilization of dental services and OHRQoL in intervention group |
Assessments will be conducted at 1 month, 3 months and 6 months after implementation of Preventive Oral Healthcare Package |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a double blinded, Two-Arm, Parallel time series, Randomized Controlled Trial comparing the effectiveness of Preventive Oral Healthcare Package versus conventional method of oral healthcare on oral health status and glycemic control among children with Type 1 Diabetes Mellitus that will be conducted in Department of Public Health Dentistry, Maulana Azad Institute of Dental Sciences, New Delhi in India. The primary outcome measure will be changes in oral health status, oral hygiene practices and caries incidence (incipient caries) in intervention group at 1, 3 and 6 months after implementation of preventive oral healthcare package. The secondary outcome will be improvement of glycemic levels in intervention group, changes in utilization of dental services and Oral health related quality of life in intervention group. |