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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01763138
Other study ID # fatima ishfaq
Secondary ID
Status Completed
Phase N/A
First received January 6, 2013
Last updated January 6, 2013
Start date June 2012
Est. completion date November 2012

Study information

Verified date January 2013
Source University of the Punjab
Contact n/a
Is FDA regulated No
Health authority Pakistan: Ministry of Health
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the effect of an educational intervention on mothers knowledge, attitudes and practices for preventing childhood caries.


Description:

Health education is being used as a key preventive tool in the prevention of chronic diseases such as heart disease, cancer, obesity, mental illness, neurological disturbances as well as dental diseases.

Amongst the dental diseases, dental caries is a high prevalence chronic childhood disease having long term growth and developmental implications . A number of educational programs have been utilized to decrease its prevalence especially in disadvantaged communities.

Dental caries is a complex interplay of a number of risk factors such as demographic (socioeconomic status, race, etc.) behavioral, dietary and cultural factors. Among the dietary intake, the most significant risk factor has been a high frequency intake of sugary foods and drinks.Patterns of sugar intake are established early in life and sugar intake increases in the first two years of life.

Early feeding practices and lack of oral hygiene maintenance have been identified as risk factors for caries in subsequent years. Maternal education can prove to be protective against dental caries by way of child's dietary practices.

Research has also indicated a reduction in prevalence of caries in children whose parents were previously participants of an oral health educational program.

Educating mothers about oral hygiene and feeding practices before the child transitions from exclusive milk diet to a variety of foods in an important time to exert a positive influence on dietary intake of child and overall oral health.


Recruitment information / eligibility

Status Completed
Enrollment 126
Est. completion date November 2012
Est. primary completion date July 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 9 Months to 15 Months
Eligibility Inclusion Criteria:

- Mothers of 9-15 months old attending the vaccination clinic who consented to be a part of the study

Exclusion Criteria:

- Mothers with severely ill children or children suffering from a co-morbid disease.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
oral health education
oral health education in the form of a pictorial pamphlet.
reminder phone call
a reminder phone call on oral health instructions would be given to mothers after every one month over a period of three months.

Locations

Country Name City State
Pakistan Children Hospital and Institute of Child Health Lahore Punjab

Sponsors (2)

Lead Sponsor Collaborator
University of the Punjab Sheikh Zayed Federal Postgraduate Medical Institute

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Other Improvement in Mothers knowledge and attitudes regarding their child's oral health An improvement in mother's knowledge and attitudes regarding their child's oral health would be assessed through the part of the questionnaire comprising of questions on fluoride, importance of milk teeth, prevention of caries etc 3 months No
Primary improvement in child's oral hygiene Increase in the frequency of tooth brushing, use of a proper oral hygiene aid would indicate an improvement in the child's oral hygiene as reported by the mother after a three month follow up period. 3 months No
Secondary reduction in sugar intake A reduction in child's sugar intake would be assessed through the followup structured questionnaire as reduced frequency of sugary snacking and a reduction in night time feeding practices. 3 months No
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