NCT04258748

Brief Summary

The purpose of this study was to evaluate the effectiveness of motivational interviewing as well as games in changing oral health behaviors among preschool children.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 29, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 4, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
Last Updated

August 20, 2020

Status Verified

August 1, 2020

Enrollment Period

2.3 years

First QC Date

February 4, 2020

Last Update Submit

August 19, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Rate of dental plaque accumulation

    It was assesed using modified OHI-S.The presence of plaque was verified on the buccal surface of 6 index teeth: the upper right second deciduous molar (tooth 55), the upper right central deciduous incisor (tooth 51), the upper left second deciduous molar (tooth 65), the lower right second deciduous molar (tooth 85), the lower left central deciduous incisor (tooth 71), and the lower left second deciduous molar (tooth 75). According to the OHI-S, dental plaque is defined as a soft organic material loosely adhering to the tooth surface. The tooth surface covered by plaque was estimated by visual examination according to the following criteria: 0 =no plaque present; 1 = plaque covering no more than 1/3 of the surface in question; 2 = plaque covering more than 1/3, but no more than 2/3 of the surface; 3= plaque covering more than 2/3 of the surface; 9 = tooth excluded, no information.

    baseline

  • Rate of dental plaque accumulation

    It was assesed using modified OHI-S.The presence of plaque was verified on the buccal surface of 6 index teeth: the upper right second deciduous molar (tooth 55), the upper right central deciduous incisor (tooth 51), the upper left second deciduous molar (tooth 65), the lower right second deciduous molar (tooth 85), the lower left central deciduous incisor (tooth 71), and the lower left second deciduous molar (tooth 75). According to the OHI-S, dental plaque is defined as a soft organic material loosely adhering to the tooth surface. The tooth surface covered by plaque was estimated by visual examination according to the following criteria: 0 =no plaque present; 1 = plaque covering no more than 1/3 of the surface in question; 2 = plaque covering more than 1/3, but no more than 2/3 of the surface; 3= plaque covering more than 2/3 of the surface; 9 = tooth excluded, no information.

    6 months

Study Arms (3)

Motivational Interviewing (MI)

EXPERIMENTAL
Behavioral: Motivational Interviewing (MI)

Gaming and MI

EXPERIMENTAL
Behavioral: Gaming and MI

Conventional dental health education

ACTIVE COMPARATOR
Behavioral: Conventional dental health education

Interventions

In each of the four MI counseling sessions that were delivered, the researcher approached mothers in small groups of 5 via three phases, in 15-30 minutes, to establish rapport/ alliance in the first phase, to identify health needs in the second phase and finally to reinforce dental needs in the third phase.

Motivational Interviewing (MI)
Gaming and MIBEHAVIORAL

In each of the four MI counseling sessions, the researcher approached mothers via three phases, in 15-30 minutes, to establish rapport/ alliance, to identify and finally reinforce dental needs in the same pattern as MI group. In addition, the children were engaged in 'Happy Teeth, Healthy Kids' which is an android tablet game that was included in the MI session scheduled for the mothers. Children were told to follow correct steps of brushing in order to obtain happy bright teeth. This helped the children realize that brushing teeth will give them a bright smile.

Gaming and MI

It was delivered through a 15-minutes oral health session given to mothers of preschoolers. Mothers were given brief information about causes of dental caries and role of plaque, toothbrush size, diet / frequency of sweet snacks, brushing technique, toothpaste and fluoride use as well as regular dental visits. Participants were then shown a short educational video about prevention of dental caries among children coupled with oral hygiene instructions. At the end of the session, participants were given a leaflet reinforcing the information to take home.

Conventional dental health education

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children having unfavorable oral health behavior (reporting a maximum tooth brushing frequency of 1-2 times/ week).
  • The child's mother agreed to join the study so that parent/child can be recruited as pairs/dyads.
  • Children enrolled in one of the nurseries selected

You may not qualify if:

  • Children having a history of serious medical condition or special care needs
  • Using any type of removable appliances such as space maintainer or tongue guard.
  • Children whose mothers refused to give consent to participate in the study.
  • Illiterate mothers who were not able to understand the oral health materials and instructions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Governmental nurseries within Edko administration

Beheira, Egypt

Location

MeSH Terms

Interventions

Motivational Interviewing

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Amani Nomair, BDS

    Faculty of Dentistry, Alexandria University, Egypt

    PRINCIPAL INVESTIGATOR
  • Maha Hamza, PhD

    Faculty of Dentistry, Alexandria University, Egypt

    STUDY DIRECTOR
  • Wafaa Essameldin, PhD

    Faculty of Dentistry, Alexandria University, Egypt

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Instructor of Dental Public Health and Statistician

Study Record Dates

First Submitted

February 4, 2020

First Posted

February 6, 2020

Study Start

May 29, 2017

Primary Completion

August 30, 2019

Study Completion

January 5, 2020

Last Updated

August 20, 2020

Record last verified: 2020-08

Locations