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Family-centered Oral Health Promotion for New Parents

Primary Purpose

Dental Caries

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Personal oral health instruction + pamphlets distribution
Pamphlets distribution
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries focused on measuring Early childhood caries (ECC), Oral health promotion, Randomized controlled trial

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • First-time pregnancy
  • Of Chinese ethnicity
  • Ability to speak Cantonese and read traditional Chinese

Exclusion Criteria:

  • Pregnant women with any communication difficulties noted
  • Informed consent not obtained

Sites / Locations

  • The University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Personal oral health instruction + pamphlets distribution

Pamphlets distribution

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Early Childhood Caries (ECC)
Prevalence of early childhood caries (ECC) among study children at 36 months
Parental Toothbrushing on Infants
Proportion of parents who brushed their infants' teeth regularly twice daily at 12 months

Secondary Outcome Measures

Feeding Habits on Infants
Proportion of infants falling asleep during milk-feeding
Ratio of Mutans Streptococci (MS)
Proportion of MS with respect to the total bacterial count
Mothers' Gingival Bleeding
Percentage of probing sites with gingival bleeding (BOP%, range 0-100%)

Full Information

First Posted
October 5, 2016
Last Updated
March 26, 2021
Sponsor
The University of Hong Kong
Collaborators
Department of Health, Hong Kong SAR Government, Hospital Authority, Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT02937194
Brief Title
Family-centered Oral Health Promotion for New Parents
Official Title
Family-centered Oral Health Promotion for New Parents and Their Infants: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 2014 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
Collaborators
Department of Health, Hong Kong SAR Government, Hospital Authority, Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
Early childhood caries (ECC), Oral health promotion, Randomized controlled trial

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
580 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Personal oral health instruction + pamphlets distribution
Arm Type
Experimental
Arm Description
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.
Arm Title
Pamphlets distribution
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Personal oral health instruction + pamphlets distribution
Intervention Description
Personal oral health instruction (OHI) and oral health pamphlets distribution
Intervention Type
Behavioral
Intervention Name(s)
Pamphlets distribution
Intervention Description
Oral health pamphlets distribution
Primary Outcome Measure Information:
Title
Early Childhood Caries (ECC)
Description
Prevalence of early childhood caries (ECC) among study children at 36 months
Time Frame
36 months
Title
Parental Toothbrushing on Infants
Description
Proportion of parents who brushed their infants' teeth regularly twice daily at 12 months
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Feeding Habits on Infants
Description
Proportion of infants falling asleep during milk-feeding
Time Frame
12 months
Title
Ratio of Mutans Streptococci (MS)
Description
Proportion of MS with respect to the total bacterial count
Time Frame
24 months
Title
Mothers' Gingival Bleeding
Description
Percentage of probing sites with gingival bleeding (BOP%, range 0-100%)
Time Frame
12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: First-time pregnancy Of Chinese ethnicity Ability to speak Cantonese and read traditional Chinese Exclusion Criteria: Pregnant women with any communication difficulties noted Informed consent not obtained
Facility Information:
Facility Name
The University of Hong Kong
City
Hong Kong
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34515552
Citation
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.
Results Reference
derived
PubMed Identifier
33066773
Citation
Liu 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.
Results Reference
derived

Learn more about this trial

Family-centered Oral Health Promotion for New Parents

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