Family-centered Oral Health Promotion for New Parents

• Sponsor: The University of Hong Kong (Other)
• Overall Status: Completed
• CT.gov ID: NCT02937194
• Collaborator: Department of Health, Hong Kong SAR Government (Other), Hospital Authority, Hong Kong (Other)
• Enrollment: 580
• Location: 1
• Arms: 2
• Actual Duration (Months): 66
• Patients Per Site Per Month: 8.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries	Behavioral: Personal oral health instruction + pamphlets distribution; Behavioral: Pamphlets distribution	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 580 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Family-centered Oral Health Promotion for New Parents and Their Infants: a Randomized Controlled Trial
• Actual Study Start Date: Jun 1, 2014
• Actual Primary Completion Date: Dec 1, 2019
• Actual Study Completion Date: Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Early Childhood Caries (ECC) [36 months]

   Prevalence of early childhood caries (ECC) among study children at 36 months

2. Parental Toothbrushing on Infants [12 months]

   Proportion of parents who brushed their infants' teeth regularly twice daily at 12 months

Secondary Outcome Measures

1. Feeding Habits on Infants [12 months]

   Proportion of infants falling asleep during milk-feeding

2. Ratio of Mutans Streptococci (MS) [24 months]

   Proportion of MS with respect to the total bacterial count

3. Mothers' Gingival Bleeding [12 months]

   Percentage of probing sites with gingival bleeding (BOP%, range 0-100%)

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Hong Kong	Hong Kong		China

Sponsors and Collaborators

• The University of Hong Kong
• Department of Health, Hong Kong SAR Government
• Hospital Authority, Hong Kong

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 25, 2018

More Information

Publications

None provided.

• Responsible Party: Professor May C.M. Wong, Professor, The University of Hong Kong
• ClinicalTrials.gov Identifier: NCT02937194
• Other Study ID Numbers: GRF HKU 782213M
• First Posted: Oct 18, 2016
• Last Update Posted: Apr 22, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Professor May C.M. Wong, Professor, The University of Hong Kong: Early childhood caries (ECC); Oral health promotion; Randomized controlled trial
• Additional relevant MeSH terms: Dental Caries

Study Results

Participant Flow

Recruitment Details

The pregnant women and their husbands were recruited from the Obstetrics & Gynaecology Department of three public hospitals and from two Maternal and Child Health Centers in Hong Kong. The potential participants were approached during their prenatal visits with minimal disturbance to the routine care at the recruitment sites. Written informed consent was obtained from both the pregnant woman and the husband. The recruitment period was from June 2014 to June 2016.

Arm/Group Title	Personal Oral Health Instruction + Pamphlets Distribution	Pamphlets Distribution
Arm/Group 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. Personal oral health instruction + pamphlets distribution: Personal oral health instruction (OHI) and oral health 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. Pamphlets distribution: Oral health pamphlets distribution
Period Title: 1-year Followup
STARTED	294	286
COMPLETED	223	218
NOT COMPLETED	71	68
Period Title: 1-year Followup
STARTED	294	286
COMPLETED	216	208
NOT COMPLETED	78	78
Period Title: 1-year Followup
STARTED	294	286
COMPLETED	228	208
NOT COMPLETED	66	78

Baseline Characteristics

Arm/Group Title	Personal Oral Health Instruction + Pamphlets Distribution	Pamphlets Distribution	Total
Arm/Group 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. Personal oral health instruction + pamphlets distribution: Personal oral health instruction (OHI) and oral health 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. Pamphlets distribution: Oral health pamphlets distribution	Total of all reporting groups
Overall Participants	294	286	580
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.7 (3.7)	31.6 (4.2)	31.7 (4.0)
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	33.9 (5.1)	33.4 (5.2)	33.6 (5.1)
Sex/Gender, Customized (Families) [Number]
Mother	294	286	580
Father	294	286	580
Race/Ethnicity, Customized (Families) [Number]
Chinese	294	286	580

Outcome Measures

1. Primary Outcome

Title	Early Childhood Caries (ECC)
Description	Prevalence of early childhood caries (ECC) among study children at 36 months
Time Frame	36 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Personal Oral Health Instruction + Pamphlets Distribution	Pamphlets Distribution
Arm/Group 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. Personal oral health instruction + pamphlets distribution: Personal oral health instruction (OHI) and oral health 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. Pamphlets distribution: Oral health pamphlets distribution
Measure Participants	228	208
Count of Participants [Participants]	8 2.7%	41 14.3%

2. Primary Outcome

Title	Parental Toothbrushing on Infants
Description	Proportion of parents who brushed their infants' teeth regularly twice daily at 12 months
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Personal Oral Health Instruction + Pamphlets Distribution	Pamphlets Distribution
Arm/Group 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. Personal oral health instruction + pamphlets distribution: Personal oral health instruction (OHI) and oral health 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. Pamphlets distribution: Oral health pamphlets distribution
Measure Participants	223	218
Count of Participants [Participants]	74 25.2%	76 26.6%

3. Secondary Outcome

Title	Feeding Habits on Infants
Description	Proportion of infants falling asleep during milk-feeding
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

The numbers of participants analyzed here are those who finished basiline and one-year follow-up examination.

Arm/Group Title	Personal Oral Health Instruction + Pamphlets Distribution	Pamphlets Distribution
Arm/Group 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. Personal oral health instruction + pamphlets distribution: Personal oral health instruction (OHI) and oral health 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. Pamphlets distribution: Oral health pamphlets distribution
Measure Participants	218	223
Count of Participants [Participants]	57 19.4%	63 22%

4. Secondary Outcome

Title	Ratio of Mutans Streptococci (MS)
Description	Proportion of MS with respect to the total bacterial count
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Personal Oral Health Instruction + Pamphlets Distribution	Pamphlets Distribution
Arm/Group 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. Personal oral health instruction + pamphlets distribution: Personal oral health instruction (OHI) and oral health 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. Pamphlets distribution: Oral health pamphlets distribution
Measure Participants	216	208
Mean (Standard Deviation) [Ratio of MS in the total bacterial count]	6.1 (15.7)	11.6 (17.8)

5. Secondary Outcome

Title	Mothers' Gingival Bleeding
Description	Percentage of probing sites with gingival bleeding (BOP%, range 0-100%)
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

The numbers of participants analyzed here are those who finished basiline and one-year follow-up gingival bleeding examination.

Arm/Group Title	Personal Oral Health Instruction + Pamphlets Distribution	Pamphlets Distribution
Arm/Group 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. Personal oral health instruction + pamphlets distribution: Personal oral health instruction (OHI) and oral health 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. Pamphlets distribution: Oral health pamphlets distribution
Measure Participants	188	181
Mean (Standard Deviation) [Percentage of sites with bleeding]	35 (29)	46 (26)

Adverse Events

Time Frame	1 year, 2 years and 3 years followup
Arm/Group Title	Personal Oral Health Instruction + Pamphlets Distribution		Pamphlets Distribution
Arm/Group 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. Personal oral health instruction + pamphlets distribution: Personal oral health instruction (OHI) and oral health 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. Pamphlets distribution: Oral health pamphlets distribution
All Cause Mortality
	Personal Oral Health Instruction + Pamphlets Distribution		Pamphlets Distribution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/294 (0%)		0/286 (0%)
Serious Adverse Events
	Personal Oral Health Instruction + Pamphlets Distribution		Pamphlets Distribution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/294 (0%)		0/286 (0%)
Other (Not Including Serious) Adverse Events
	Personal Oral Health Instruction + Pamphlets Distribution		Pamphlets Distribution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/294 (0%)		0/286 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.