Dental CariesNCT01763138
Effect of Educational Intervention in Mothers for Prevention of Caries in Their Children
A study testing oral health education and reminder phone call in people with Dental Caries, run by University of the Punjab at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 9 to 15 monthsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- oral health education and reminder phone call
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 sitePakistan
- Study dates
- Jun 2012to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 15 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Mothers of 9-15 months old attending the vaccination clinic who consented to be a part of the study
Who cannot join
- Mothers with severely ill children or children suffering from a co-morbid disease.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Children Hospital and Institute of Child Health
Lahore, Punjab Province
About this study
Official title: Effect of Educational Intervention in Mothers for Prevention of Caries in Their Children, A Randomized Controlled Trial
The purpose of this study is to determine the effect of an educational intervention on mothers knowledge, attitudes and practices for preventing childhood caries.
Read the 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.
- Conditions
- Dental Caries
- Being tested
- oral health education, reminder phone call
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral health educationBehavioural
oral health education in the form of a pictorial pamphlet.
reminder phone callBehavioural
a reminder phone call on oral health instructions would be given to mothers after every one month over a period of three months.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: oral health education; Behavioral: reminder phone call |
| pamphlet only | Other | oral health education pictorial pamphlet would be provided to mothers however there will be no reminder phone calls. Receives: Behavioral: oral health education |
| control | No intervention | no oral health education or reminder phone calls will be provided to mothers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2013 (estimated)
- Study startJun 2012
- Primary completionJul 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Punjab
- Sponsor type
- University, hospital or other
- Collaborators
- Sheikh Zayed Federal Postgraduate Medical Institute
- Responsible party
- Principal investigator, Dr Fatima Ishfaq, University of the Punjab
- Investigators
- Fatima Ishfaq, BDS, Principal investigator, Sheikh Zayed Federal Postgraduate Medical Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01763138
- Sponsor's protocol ID
- fatima ishfaq
- Status last verified
- Jan 2013
- First submitted
- 6 Jan 2013
- Last updated
- 8 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Educational Intervention in Mothers for Prevention of Caries in Their Children, A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01763138
- Acronym / sponsor ID
- fatima ishfaq
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University of the PunjabUniversity, hospital or other
- Collaborators
- Sheikh Zayed Federal Postgraduate Medical Institute
- Study start
- Jun 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 8 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pamphlet and reminder | Other | Behavioral: oral health education, Behavioral: reminder phone callpictorial 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. |
| pamphlet only | Other | Behavioral: oral health educationoral health education pictorial pamphlet would be provided to mothers however there will be no reminder phone calls. |
| control | No intervention | –no oral health education or reminder phone calls will be provided to mothers. |
Who may qualify
- Ages
- 9 to 15 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Mothers of 9-15 months old attending the vaccination clinic who consented to be a part of the study
Key exclusion criteria (1 listed)
- Mothers with severely ill children or children suffering from a co-morbid disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral health educationoral health education in the form of a pictorial pamphlet. | Behavioural | pamphlet and reminder, pamphlet only |
| reminder phone calla reminder phone call on oral health instructions would be given to mothers after every one month over a period of three months. | Behavioural | pamphlet and reminder |
Primary outcome
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.
1 secondary outcome
reduction in sugar intake
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2013.
Related trials for Dental Caries
Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatima Ishfaq, BDS principal investigator
Sheikh Zayed Federal Postgraduate Medical Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral health education and reminder phone call in people with Dental Caries, run by University of the Punjab at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement in child's oral hygiene (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2013; AzTrials last refreshed its copy on 8 Nov 2026.