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Effect of Educational Intervention in Mothers for Prevention of Caries in Their Children

Primary Purpose

Dental Caries

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
oral health education
reminder phone call
Sponsored by
University of the Punjab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries

Eligibility Criteria

9 Months - 15 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Children Hospital and Institute of Child Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

No Intervention

Arm Label

pamphlet and reminder

pamphlet only

control

Arm Description

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 pictorial pamphlet would be provided to mothers however there will be no reminder phone calls.

no oral health education or reminder phone calls will be provided to mothers.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 6, 2013
Last Updated
January 6, 2013
Sponsor
University of the Punjab
Collaborators
Sheikh Zayed Federal Postgraduate Medical Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01763138
Brief Title
Effect of Educational Intervention in Mothers for Prevention of Caries in Their Children
Official Title
Effect of Educational Intervention in Mothers for Prevention of Caries in Their Children, A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of the Punjab
Collaborators
Sheikh Zayed Federal Postgraduate Medical Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pamphlet and reminder
Arm Type
Other
Arm Description
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.
Arm Title
pamphlet only
Arm Type
Other
Arm Description
oral health education pictorial pamphlet would be provided to mothers however there will be no reminder phone calls.
Arm Title
control
Arm Type
No Intervention
Arm Description
no oral health education or reminder phone calls will be provided to mothers.
Intervention Type
Behavioral
Intervention Name(s)
oral health education
Intervention Description
oral health education in the form of a pictorial pamphlet.
Intervention Type
Behavioral
Intervention Name(s)
reminder phone call
Intervention Description
a reminder phone call on oral health instructions would be given to mothers after every one month over a period of three months.
Primary Outcome Measure Information:
Title
improvement in child's oral hygiene
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
reduction in sugar intake
Description
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.
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Improvement in Mothers knowledge and attitudes regarding their child's oral health
Description
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
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Months
Maximum Age & Unit of Time
15 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatima Ishfaq, BDS
Organizational Affiliation
Sheikh Zayed Federal Postgraduate Medical Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children Hospital and Institute of Child Health
City
Lahore
State/Province
Punjab
Country
Pakistan

12. IPD Sharing Statement

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Effect of Educational Intervention in Mothers for Prevention of Caries in Their Children

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