Reduction of dental problems in young children

Not yet recruiting

Conditions: prevention of oral diseases among children of age less than 6 years

Registration Number: CTRI/2019/02/017556

Lead Sponsor: Oral Health Sciences Centre PGIMER

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 1900

Inclusion Criteria

(a)Children of the age 1 to 6 years.
(b)Child with at least one primary tooth present.

Exclusion Criteria

(a) Involvement in other clinical trials or protocols related to oral health interventions (b) Allergy to the varnishâ€™s component or povidone iodine (c) If no teeth or only stainless steel crowns are present.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (2): PGIMER
🇮🇳
Chandigarh, CHANDIGARH, India
SCB Dental College and Hospital
🇮🇳
Cuttack, ORISSA, India
PGIMER
🇮🇳Chandigarh, CHANDIGARH, India
Dr Ashima Goyal
Principal investigator
01722756832
ashimapgi@yahoo.in