CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 580 enrolled
Drug / intervention
Personal oral health instruction + pamphlets distribution +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02937194
NCT02937194N/ACompleted

Family-centered Oral Health Promotion for New Parents and Their Infants: a Randomized Controlled Trial

The University of Hong Kong·interventional·Posted Oct 18, 2016·Updated Apr 22, 2021

In Brief

A clinical study evaluating Personal oral health instruction + pamphlets distribution and Pamphlets distribution for Dental Caries. Completed, enrolled 580 participants across 1 site.

Detailed 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. 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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDental Caries
CountriesChina

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 18, 2016
Enrollment StartJun 1, 2014
Primary CompletionDec 1, 2019
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 9.7 years ago

Interventions

Personal oral health instruction + pamphlets distributionbehavioral

Personal oral health instruction (OHI) and oral health pamphlets distribution

Pamphlets distributionbehavioral

Oral health pamphlets distribution