| CTRI Number |
CTRI/2019/02/017556 [Registered on: 08/02/2019] Trial Registered Prospectively |
| Last Modified On: |
07/02/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening
Dentistry
Process of Care Changes
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Reduction of dental problems in young children |
|
Scientific Title of Study
|
A community-based pragmatic, controlled trial for prevention and reduction of oral diseases among children at the anganwadi centres located in peri-urban areas of Chandigarh and rural parts of Cuttack, Orissa. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashima Goyal |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Sciences and Research, Chandigarh |
| Address |
Unit of Pedodontics and Preventive Dentistry, Oral Health Sciences Centre, PGIMER, Sector - 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
1722756832 |
| Fax |
|
| Email |
ashimapgi@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashima Goyal |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Sciences and Research, Chandigarh |
| Address |
Unit of Pedodontics and Preventive Dentistry, Oral Health Sciences Centre, PGIMER, Sector - 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
1722756832 |
| Fax |
|
| Email |
ashimapgi@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Ashima Goyal |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Sciences and Research, Chandigarh |
| Address |
Unit of Pedodontics and Preventive Dentistry, Oral Health Sciences Centre, PGIMER, Sector - 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
1722756832 |
| Fax |
|
| Email |
ashimapgi@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research, New Delhi |
|
|
Primary Sponsor
|
| Name |
Oral Health Sciences Centre PGIMER |
| Address |
Sector 12, Chandigarh - 160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Ashish Joshi |
Foundation of Healthcare Technologies Society, 518 and 518A, 5th Floor Somdutt Chamber-II, Bhikaji Cama Place, New Delhi, Delhi 110066 |
| Dr Utkal Mohanty |
SCB Dental College, Cuttack |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashima Goyal |
PGIMER |
Oral Health Sciences Centre
Chandigarh
CHANDIGARH |
01722756832
ashimapgi@yahoo.in |
| Dr Utkal Mohanty |
SCB Dental College and Hospital |
Unit of Public Health Dentistry
Cuttack
ORISSA |
9437953285
utkalcommunity@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Postgraduate Institute of Medical Education & Research Chandigarh |
Approved |
| Institutional Ethics Committee SCB Dental College and Hospital Cuttack Odisha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
prevention of oral diseases among children of age less than 6 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral Health Education and topical application of fluoride varnish and povidone iodine on teeth |
Anganwadi workers of the selected anganwadis shall be trained on oral health promotion. These trained anganwadi workers shall in turn train and educate mothers on oral disease prevention of their children. Additionally, all the 1-6 year old children of the selected anganwadi centres shall receive oral disease preventive agents (i.e. topical application of fluoride varnish and povidone iodine) on regular intervals by the dentists recruited in this project. |
| Comparator Agent |
oral health information |
oral health information pamphlet will be given to mothers visiting the selected anganwadis in the control group |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
(a) Children of the age 1 to 6 years.
(b) Child with at least one primary tooth present
|
|
| ExclusionCriteria |
| Details |
(a) Involvement in other clinical trials or protocols related to oral health interventions
(b) Allergy to the varnish’s component or povidone iodine
(c) If no teeth or only stainless steel crowns are present |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in decayed missing filled surfaces (dmfs) score among children who were aged 1 to 3 years at the start of study |
three-year follow-up period from the initial assessment at the begining of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in (i) S. Mutans levels, (ii) gingival disease status among children who will be aged 1 to 3 years at the start of study and change in KAP scores of their mothers |
three-year follow-up period from the initial assessment at the begining of study |
| Change in dmfs score, S. mutans levels, GI score among children aged 1 to 3 years and KAP scores of their mothers |
at 6 months, 1 year and 2 year follow-up period from the initial assessment at the begining of study |
| Raw dmfs scores, S. mutans levels, GI score among all available children aged 1 to 6 years and KAP scores of their mothers |
at 6 months, 1 year, 2 year and 3 year follow-up period from the initial assessment at the begining of study |
|
|
Target Sample Size
|
Total Sample Size="1900"
Sample Size from India="1900"
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)
|
01/03/2019 |
| 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="4"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The present proposal is a pragmatic community-based, controlled, intervention trial proposed to be carried out in peri-urban areas of Chandigarh and rural areas of Cuttack, Orissa. Two geographically distant ICDS blocks would be selected at each of the two study centres viz. Chandigarh and Cuttack. The two selected blocks would be randomly allocated to intervention and control group using sealed envelopes. Anganwadi centres under each of the two selected blocks shall be enumerated and those anganwadi centres would be selected which are located closer to each other so that a cluster of anganwadi centres is formed within the block. Oral Health Care Package (OHCP) would be delivered to all the 0-6 year old children in the experimental group anganwadi centres whereas mothers and their children visiting the anganwadi centres under control group will only receive usual care available at the anganwadi centres. The primary analysis will be inter-group comparison of a cohort of children aged 1 to 3 years who will be recruited at the beginning of the study and shall be followed up for 3 years until the age of 4 to 6 years respectively for difference in dental caries levels, salivary S mutans levels and gingival disease status. Secondarily, a cross-sectional inter-group comparison of all available children aged 1 to 6 years present at the end of the study shall also be carried out. Similarly KAP regarding oral health among anganwadi workers and mothers shall be evaluated before intervention and at 6 months, 1 year, 2 year and 3year in cohort and cross-sectional manner. Up scaling of the project can be done to other anganwadi centres of the country if the present approach is found to be effective and practical. |