Trial Outcomes & Findings for Family-centered Oral Health Promotion for New Parents (NCT NCT02937194)
NCT ID: NCT02937194
Last Updated: 2021-04-22
Results Overview
Prevalence of early childhood caries (ECC) among study children at 36 months
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
580 participants
Primary outcome timeframe
36 months
Results posted on
2021-04-22
Participant Flow
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.
Participant milestones
| Measure |
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.
Personal oral health instruction + pamphlets distribution: Personal oral health instruction (OHI) and oral health pamphlets distribution
|
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
|
|---|---|---|
|
1-year Followup
STARTED
|
294
|
286
|
|
1-year Followup
COMPLETED
|
223
|
218
|
|
1-year Followup
NOT COMPLETED
|
71
|
68
|
|
2-years Followup
STARTED
|
294
|
286
|
|
2-years Followup
COMPLETED
|
216
|
208
|
|
2-years Followup
NOT COMPLETED
|
78
|
78
|
|
3-years Followup
STARTED
|
294
|
286
|
|
3-years Followup
COMPLETED
|
228
|
208
|
|
3-years Followup
NOT COMPLETED
|
66
|
78
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Family-centered Oral Health Promotion for New Parents
Baseline characteristics by cohort
| Measure |
Personal Oral Health Instruction + Pamphlets Distribution
n=294 Participants
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 Distribution
n=286 Participants
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
n=580 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.9 years
STANDARD_DEVIATION 5.1 • n=93 Participants
|
33.4 years
STANDARD_DEVIATION 5.2 • n=4 Participants
|
33.6 years
STANDARD_DEVIATION 5.1 • n=27 Participants
|
|
Sex/Gender, Customized
Mother
|
294 Families
n=93 Participants
|
286 Families
n=4 Participants
|
580 Families
n=27 Participants
|
|
Sex/Gender, Customized
Father
|
294 Families
n=93 Participants
|
286 Families
n=4 Participants
|
580 Families
n=27 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
294 Families
n=93 Participants
|
286 Families
n=4 Participants
|
580 Families
n=27 Participants
|
PRIMARY outcome
Timeframe: 36 monthsPrevalence of early childhood caries (ECC) among study children at 36 months
Outcome measures
| Measure |
Personal Oral Health Instruction + Pamphlets Distribution
n=228 Participants
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 Distribution
n=208 Participants
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
|
|---|---|---|
|
Early Childhood Caries (ECC)
|
8 Participants
|
41 Participants
|
PRIMARY outcome
Timeframe: 12 monthsProportion of parents who brushed their infants' teeth regularly twice daily at 12 months
Outcome measures
| Measure |
Personal Oral Health Instruction + Pamphlets Distribution
n=223 Participants
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 Distribution
n=218 Participants
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
|
|---|---|---|
|
Parental Toothbrushing on Infants
|
74 Participants
|
76 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The numbers of participants analyzed here are those who finished basiline and one-year follow-up examination.
Proportion of infants falling asleep during milk-feeding
Outcome measures
| Measure |
Personal Oral Health Instruction + Pamphlets Distribution
n=218 Participants
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 Distribution
n=223 Participants
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
|
|---|---|---|
|
Feeding Habits on Infants
|
57 Participants
|
63 Participants
|
SECONDARY outcome
Timeframe: 24 monthsProportion of MS with respect to the total bacterial count
Outcome measures
| Measure |
Personal Oral Health Instruction + Pamphlets Distribution
n=216 Participants
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 Distribution
n=208 Participants
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
|
|---|---|---|
|
Ratio of Mutans Streptococci (MS)
|
6.1 Ratio of MS in the total bacterial count
Standard Deviation 15.7
|
11.6 Ratio of MS in the total bacterial count
Standard Deviation 17.8
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The numbers of participants analyzed here are those who finished basiline and one-year follow-up gingival bleeding examination.
Percentage of probing sites with gingival bleeding (BOP%, range 0-100%)
Outcome measures
| Measure |
Personal Oral Health Instruction + Pamphlets Distribution
n=188 Participants
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 Distribution
n=181 Participants
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
|
|---|---|---|
|
Mothers' Gingival Bleeding
|
35 Percentage of sites with bleeding
Standard Deviation 29
|
46 Percentage of sites with bleeding
Standard Deviation 26
|
Adverse Events
Personal Oral Health Instruction + Pamphlets Distribution
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pamphlets Distribution
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place