- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01763138
Effect of Educational Intervention in Mothers for Prevention of Caries in Their Children
Effect of Educational Intervention in Mothers for Prevention of Caries in Their Children, A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
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Lahore, Punjab, Pakistan
- Children Hospital and Institute of Child Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: pamphlet and reminder
pictorial oral health pamphlet comprising of instructions on child's oral hygiene and feeding practices and a oral health education reminder phone call after a period of one month.
|
oral health education in the form of a pictorial pamphlet.
a reminder phone call on oral health instructions would be given to mothers after every one month over a period of three months.
|
Other: pamphlet only
oral health education pictorial pamphlet would be provided to mothers however there will be no reminder phone calls.
|
oral health education in the form of a pictorial pamphlet.
|
No Intervention: control
no oral health education or reminder phone calls will be provided to mothers.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
improvement in child's oral hygiene
Time Frame: 3 months
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
reduction in sugar intake
Time Frame: 3 months
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in Mothers knowledge and attitudes regarding their child's oral health
Time Frame: 3 months
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Fatima Ishfaq, BDS, Sheikh Zayed Federal Postgraduate Medical Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- fatima ishfaq
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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