NCT04317768

Brief Summary

Jordanian children have very poor oral hygiene parameters, and this is reflected as very high caries prevalence and poor gingival health conditions. This study will focus on children at social homes in the community in order to establish a baseline reference about their oral health status, treatment needs, and barriers to dental care. Also, to report the efficacy of oral health education using audio-visual aids and frequent motivation on oral health status, treatment needs and barriers to care among children at social homes in Jordan.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
232

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

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

February 1, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 23, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

March 30, 2021

Status Verified

March 1, 2021

Enrollment Period

1.3 years

First QC Date

March 19, 2020

Last Update Submit

March 27, 2021

Conditions

Keywords

Oral health statusDental treatment needsBarriers to dental careChildren at social homes

Outcome Measures

Primary Outcomes (3)

  • Measure of dental caries

    Decayed, missing, filled teeth

    1 year

  • Gingival health

    Presence or absence of gingival inflammation

    1 year

  • Oral hygiene

    Presence or absence of dental plaque

    1 year

Study Arms (2)

Study group

EXPERIMENTAL

They will be educated and motivated by an intensive program consisting of verbal instructions, Power Point lectures, posters and live demonstrations about oral hygiene instructions and teaching the proper way to brush the teeth. These will be reinforced by the investigator at intervals of 1 week, 1 month, 3 months, 6 months and 1 year.

Behavioral: Basic oral health education and motivationBehavioral: Intensive oral health education and motivation

Control group

OTHER

They will receive verbal oral hygiene instructions using a model to demonstrate only once at the beginning of the study, no further motivation or educational seminars will be done.

Behavioral: Basic oral health education and motivation

Interventions

Subjects will receive verbal oral hygiene instructions using a model to demonstrate only once at the beginning of the study, no further motivation or educational seminars will be done.

Control groupStudy group

Subjects will be educated and motivated by an intensive program consisting of verbal instructions, PowerPoint lectures, posters and live demonstrations about oral hygiene instructions and teaching the proper way to brush the teeth. These will be reinforced by the investigator at intervals of 1 week, 1 month, 3 months, 6 months and 1 year.

Study group

Eligibility Criteria

Age4 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy children living in social homes among age group specified

You may not qualify if:

  • Children with poor behavior

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jordan University of Science and Technology

Irbid, 22110, Jordan

Location

MeSH Terms

Conditions

Dental CariesGingivitis

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic DiseasesInfectionsGingival DiseasesPeriodontal DiseasesMouth Diseases

Study Officials

  • Ola Al-Batayneh

    Jordan University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The statistician is blinded to groups.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This is a cross-sectional study on a randomly selected group of children from randomly selected social homes in Jordan. Children and/or the care giver (n=500) will answer a questionnaire in an interview about his/her demographics, oral health related habits, the child general health status, the child oral health related quality of life, barriers to getting dental care, treatment needs for those children. A thorough clinical examination will be done to these children by a mouth mirror and explorer at a suitable room in the social home. The investigators will record the baseline oral health status parameters (Caries, gingival health and presence of plaque). For the interventions; A representative sample (25%) will be divided to two subgroups; group one (Study) and group two (Control) which will be matched for age and gender.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2020

First Posted

March 23, 2020

Study Start

February 1, 2019

Primary Completion

May 15, 2020

Study Completion

June 30, 2020

Last Updated

March 30, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations