Dental CariesNCT02937194
Family-centered Oral Health Promotion for New Parents
A study testing Personal oral health instruction + pamphlets distribution and Pamphlets distribution in people with Dental Caries, run by The University of Hong Kong at 1 site in China.
Trial summary
Early childhood caries (ECC) is a global health problem that causes pain and infection to the children affected. It is a common disease among preschool children in Hong Kong. There is a great need to improve at-home ECC preventive measures through oral health promotional activities as early as possible to parents. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dental Caries
- What is being tested?
- Personal oral health instruction + pamphlets distribution and Pamphlets distribution
- 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
- 580 participants
- Where
- 1 siteChina
- Study dates
- Jun 2014to Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- First-time pregnancy
- Of Chinese ethnicity
- Ability to speak Cantonese and read traditional Chinese
Who cannot join
- Pregnant women with any communication difficulties noted
- Informed consent not obtained
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Family-centered Oral Health Promotion for New Parents and Their Infants: a Randomized Controlled Trial
Early childhood caries (ECC) is a global health problem that causes pain and infection to the children affected. It is a common disease among preschool children in Hong Kong. There is a great need to improve at-home ECC preventive measures through oral health promotional activities as early as possible to parents.
The investigators will propose a 4-year randomized controlled trial of family-centered oral health promotion for new parents which aims to increase the proportion of parents brushing their infants' teeth at 1 year, establishing proper feeding and dietary habits, reducing the transfer of MS from the parents to their infants and then reducing the risk of ECC of the children at 3 years. The investigators also aim to improve the oral hygiene status of the new parents and prevention of oral diseases among themselves.
Read more
First-time expectant mothers and their husbands will be recruited. The recruited families will be randomly allocated to the test and control groups. In the test group, personal hygiene instruction (OHI) for the expectant mothers and their husbands together with oral health education materials on infant's tooth development and eruption, establishment of proper feeding, dietary and toothbrushing habits will be given before the delivery of the new born babies. Reinforcement of OHI and demonstrations on how to clean the infant's oral cavities and perform toothbrushing will be delivered after the babies are born. Comprehensive data will be collected from the mothers, fathers and the infants in both the test and control groups at different time points through dental examination, biological testing and questionnaire survey. The CONSORT statement will be strictly followed when conducting the clinical trial, analyzing the data and reporting the results.
It is anticipated that the effectiveness of oral health promotion starting at the pregnancy period and for both expecting mothers and their husbands will be greater in preventing the infants from developing ECC. Furthermore, establishing good oral health care habits will have long term benefits, helping safeguard the oral health of the children as they grow and the family as a whole. This study will also provide much needed evidence for the further development of oral health policies and oral health promotion programmes in Hong Kong; specifically how these can be integrated into family health education so as to achieve a higher effectiveness. This will contribute significantly to the improvement of oral health in the population of Hong Kong.
- Conditions
- Dental Caries
- Being tested
- Personal oral health instruction + pamphlets distribution, Pamphlets distribution
- Keywords
- Early childhood caries (ECC), Oral health promotion, Randomized controlled trial
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personal oral health instruction + pamphlets distributionBehavioural
Personal oral health instruction (OHI) and oral health pamphlets distribution
Pamphlets distributionBehavioural
Oral health pamphlets distribution
| Study group | Role | What they receive |
|---|---|---|
| Personal oral health instruction + pamphlets distribution | Experimental | Personal oral health instruction (OHI) for the expectant mothers and their husbands together with oral health education materials on infant's tooth development and eruption, establishment of proper feeding, dietary and toothbrushing habits will be given before baby delivery. Reinforcement of OHI and demonstrations on how to clean the infant's oral cavities and perform toothbrushing will be delivered after the babies are born. Receives: Behavioral: Personal oral health instruction + pamphlets distribution |
| Pamphlets distribution | Active comparator | Pamphlets for adults' and pregnant women's oral health care will be distributed when recruited and information on the babies' oral health care will be distributed before baby delivery. Receives: Behavioral: Pamphlets distribution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Childhood Caries (ECC)
Prevalence of early childhood caries (ECC) among study children at 36 months
Measured: 36 months
Parental Toothbrushing on Infants
Proportion of parents who brushed their infants' teeth regularly twice daily at 12 months
Measured: 12 months
Secondary outcomes (3)
Feeding Habits on Infants
Proportion of infants falling asleep during milk-feeding
Measured: 12 months
Ratio of Mutans Streptococci (MS)
Proportion of MS with respect to the total bacterial count
Measured: 24 months
Mothers' Gingival Bleeding
Percentage of probing sites with gingival bleeding (BOP%, range 0-100%)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startJun 2014
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 580 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Hong Kong Government, Hospital Authority, Hong Kong
- Responsible party
- Principal investigator, Professor May C.M. Wong, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02937194
- Sponsor's protocol ID
- GRF HKU 782213M
- Status last verified
- Mar 2021
- First submitted
- 5 Oct 2016
- Last updated
- 22 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Yu KF, Wen W, Liu P, Gao X, Lo ECM, Wong MCM. Effectiveness of Family-Centered Oral Health Promotion on Toddler Oral Health in Hong Kong. J Dent Res. 2022 Mar;101(3):286-294. doi: 10.1177/00220345211036663. Epub 2021 Sep 13.
PubMed 34515552Liu P, Wen W, Yu KF, Gao X, Lo ECM, Wong MCM. Effectiveness of a family-centered behavioral and educational counselling approach to improve periodontal health of pregnant women: a randomized controlled trial. BMC Oral Health. 2020 Oct 16;20(1):284. doi: 10.1186/s12903-020-01265-6.
PubMed 33066773
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-centered Oral Health Promotion for New Parents and Their Infants: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02937194
- Acronym / sponsor ID
- GRF HKU 782213M
- Conditions
- Dental Caries
- Keywords
- Early childhood caries (ECC), Oral health promotion, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 580 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Hong Kong Government, Hospital Authority, Hong Kong
- Study start
- Jun 2014 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 18 Oct 2016 (estimated)
- Results
- Posted 22 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Early childhood caries (ECC) is a global health problem that causes pain and infection to the children affected. It is a common disease among preschool children in Hong Kong. There is a great need to improve at-home ECC preventive measures through oral health promotional activities as early as possible to parents.
The investigators will propose a 4-year randomized controlled trial of family-centered oral health promotion for new parents which aims to increase the proportion of parents brushing their infants' teeth at 1 year, establishing proper feeding and dietary habits, reducing the transfer of MS from the parents to their infants and then reducing the risk of ECC of the children at 3 years. The investigators also aim to improve the oral hygiene status of the new parents and prevention of oral diseases among themselves.
First-time expectant mothers and their husbands will be recruited. The recruited families will be randomly allocated to the test and control groups. In the test group, personal hygiene instruction (OHI) for the expectant mothers and their husbands together with oral health education materials on infant's tooth development and eruption, establishment of proper feeding, dietary and toothbrushing habits will be given before the delivery of the new born babies. Reinforcement of OHI and demonstrations on how to clean the infant's oral cavities and perform toothbrushing will be delivered after the babies are born. Comprehensive data will be collected from the mothers, fathers and the infants in both the test and control groups at different time points through dental examination, biological testing and questionnaire survey. The CONSORT statement will be strictly followed when conducting the clinical trial, analyzing the data and reporting the results.
It is anticipated that the effectiveness of oral health promotion starting at the pregnancy period and for both expecting mothers and their husbands will be greater in preventing the infants from developing ECC. Furthermore, establishing good oral health care habits will have long term benefits, helping safeguard the oral health of the children as they grow and the family as a whole. This study will also provide much needed evidence for the further development of oral health policies and oral health promotion programmes in Hong Kong; specifically how these can be integrated into family health education so as to achieve a higher effectiveness. This will contribute significantly to the improvement of oral health in the population of Hong Kong.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personal oral health instruction + pamphlets distribution | Experimental | Behavioral: Personal oral health instruction + pamphlets distributionPersonal oral health instruction (OHI) for the expectant mothers and their husbands together with oral health education materials on infant's tooth development and eruption, establishment of proper feeding, dietary and toothbrushing habits will be given before baby delivery. Reinforcement of OHI and demonstrations on how to clean the infant's oral cavities and perform toothbrushing will be delivered after the babies are born. |
| Pamphlets distribution | Active comparator | Behavioral: Pamphlets distributionPamphlets for adults' and pregnant women's oral health care will be distributed when recruited and information on the babies' oral health care will be distributed before baby delivery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- First-time pregnancy
- Of Chinese ethnicity
- Ability to speak Cantonese and read traditional Chinese
Key exclusion criteria (2 listed)
- Pregnant women with any communication difficulties noted
- Informed consent not obtained
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 |
|---|---|---|
| Personal oral health instruction + pamphlets distributionPersonal oral health instruction (OHI) and oral health pamphlets distribution | Behavioural | Personal oral health instruction + pamphlets distribution |
| Pamphlets distributionOral health pamphlets distribution | Behavioural | Pamphlets distribution |
Primary outcome
Early Childhood Caries (ECC)
Time frame: 36 months
Prevalence of early childhood caries (ECC) among study children at 36 months
Parental Toothbrushing on Infants
Time frame: 12 months
Proportion of parents who brushed their infants' teeth regularly twice daily at 12 months
3 secondary outcomes
Feeding Habits on Infants
Time frame: 12 months
Ratio of Mutans Streptococci (MS)
Time frame: 24 months
Mothers' Gingival Bleeding
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34515552Yu KF, Wen W, Liu P, Gao X, Lo ECM, Wong MCM. Effectiveness of Family-Centered Oral Health Promotion on Toddler Oral Health in Hong Kong. J Dent Res. 2022 Mar;101(3):286-294. doi: 10.1177/00220345211036663. Epub 2021 Sep 13.
- Derived from this study: PubMed 33066773Liu P, Wen W, Yu KF, Gao X, Lo ECM, Wong MCM. Effectiveness of a family-centered behavioral and educational counselling approach to improve periodontal health of pregnant women: a randomized controlled trial. BMC Oral Health. 2020 Oct 16;20(1):284. doi: 10.1186/s12903-020-01265-6.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personal oral health instruction + pamphlets distribution and Pamphlets distribution in people with Dental Caries, run by The University of Hong Kong at 1 site in China.
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 3 inclusion and 2 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 22 Apr 2021. 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 China. 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?
Yes. Results are posted in the registry (first posted 22 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Early Childhood Caries (ECC) (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02937194, which also lists 2 linked publications.
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 22 Apr 2021.