ClinicalTrials.gov
ClinicalTrials.gov Menu

Family-centered Oral Health Promotion for New Parents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02937194
Recruitment Status : Recruiting
First Posted : October 18, 2016
Last Update Posted : October 18, 2016
Sponsor:
Collaborators:
Department of Health, Hong Kong SAR Government
Hospital Authority, Hong Kong
Information provided by (Responsible Party):
Professor May C.M. Wong, The University of Hong Kong

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 584 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
Study Start Date : January 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Early childhood caries (ECC) [ Time Frame: 36 months ]
    Prevalence of early childhood caries (ECC) among infants at 36 months

  2. Toothbrushing on infants [ Time Frame: 12 months ]
    Proportion of parents who will brush their infants' teeth regularly at 12 months


Secondary Outcome Measures :
  1. Feeding and dietary habits on infants [ Time Frame: 12 months ]
    Infants' feeding and dietary habits at 12 months

  2. Visible plaque [ Time Frame: 12 months, 24 months and 36 months ]
    Mothers' , fathers' and infant's oral hygiene status over the study period

  3. Caries increment [ Time Frame: 12 months, 24 months and 36 months ]
    Mothers' and fathers' dental caries increment over the study period

  4. Mutans Streptococci (MS) [ Time Frame: 12 months, 24 months and 36 months ]
    Mothers' and children's mutans streptococci (MS) counts over the study period

  5. Change in periodontal condition [ Time Frame: 12 months, 24 months and 36 months ]
    Mothers' and fathers' change in periodontal condition over the study period



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
Contact: May Chun Mei WONG, BSocSc, MPhil, PhD +(852) 28590422 mcmwong@hku.hk

Locations
China
The University of Hong Kong Recruiting
Hong Kong, China
Contact: May Chun Mei WONG, BSocSc, MPhil, PhD    +(852) 28590422    mcmwong@hku.hk   
Sponsors and Collaborators
The University of Hong Kong
Department of Health, Hong Kong SAR Government
Hospital Authority, Hong Kong

Responsible Party: Professor May C.M. Wong, Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02937194     History of Changes
Other Study ID Numbers: GRF HKU 782213M
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Professor May C.M. Wong, The University of Hong Kong:
Early childhood caries (ECC)
Oral health promotion
Randomized controlled trial

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases