Family-centered Oral Health Promotion for New Parents
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|ClinicalTrials.gov Identifier: NCT02937194|
Recruitment Status : Recruiting
First Posted : October 18, 2016
Last Update Posted : October 18, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Dental Caries||Behavioral: Personal oral health instruction + pamphlets distribution Behavioral: Pamphlets distribution||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||584 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Family-centered Oral Health Promotion for New Parents and Their Infants: a Randomized Controlled Trial|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Personal oral health instruction + pamphlets distribution
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.
Behavioral: Personal oral health instruction + pamphlets distribution
Personal oral health instruction (OHI) and oral health pamphlets distribution
Active Comparator: Pamphlets distribution
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.
Behavioral: Pamphlets distribution
Oral health pamphlets distribution
- Early childhood caries (ECC) [ Time Frame: 36 months ]Prevalence of early childhood caries (ECC) among infants at 36 months
- Toothbrushing on infants [ Time Frame: 12 months ]Proportion of parents who will brush their infants' teeth regularly at 12 months
- Feeding and dietary habits on infants [ Time Frame: 12 months ]Infants' feeding and dietary habits at 12 months
- Visible plaque [ Time Frame: 12 months, 24 months and 36 months ]Mothers' , fathers' and infant's oral hygiene status over the study period
- Caries increment [ Time Frame: 12 months, 24 months and 36 months ]Mothers' and fathers' dental caries increment over the study period
- Mutans Streptococci (MS) [ Time Frame: 12 months, 24 months and 36 months ]Mothers' and children's mutans streptococci (MS) counts over the study period
- Change in periodontal condition [ Time Frame: 12 months, 24 months and 36 months ]Mothers' and fathers' change in periodontal condition over the study period
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02937194
|Contact: May Chun Mei WONG, BSocSc, MPhil, PhD||+(852) email@example.com|
|The University of Hong Kong||Recruiting|
|Hong Kong, China|
|Contact: May Chun Mei WONG, BSocSc, MPhil, PhD +(852) 28590422 firstname.lastname@example.org|