NCT01763138

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 8, 2013

Completed
Last Updated

January 8, 2013

Status Verified

January 1, 2013

Enrollment Period

1 month

First QC Date

January 6, 2013

Last Update Submit

January 6, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • reduction in sugar intake

    3 months

Other Outcomes (1)

  • Improvement in Mothers knowledge and attitudes regarding their child's oral health

    3 months

Study Arms (3)

pamphlet and reminder

OTHER

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.

Behavioral: oral health educationBehavioral: reminder phone call

pamphlet only

OTHER

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

Behavioral: oral health education

control

NO INTERVENTION

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

Interventions

oral health education in the form of a pictorial pamphlet.

pamphlet and reminderpamphlet only

a reminder phone call on oral health instructions would be given to mothers after every one month over a period of three months.

pamphlet and reminder

Eligibility Criteria

Age9 Months - 15 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children Hospital and Institute of Child Health

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Dental Caries

Interventions

Health Education, Dental

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPublic Health DentistryEnvironment and Public Health

Study Officials

  • Fatima Ishfaq, BDS

    Sheikh Zayed Federal Postgraduate Medical Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Fatima Ishfaq

Study Record Dates

First Submitted

January 6, 2013

First Posted

January 8, 2013

Study Start

June 1, 2012

Primary Completion

July 1, 2012

Study Completion

November 1, 2012

Last Updated

January 8, 2013

Record last verified: 2013-01

Locations