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Effect of Oral Health Education on Oral Health Status, Treatment Needs and Barriers to Care

Primary Purpose

Dental Caries, Gingivitis

Status
Completed
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Basic oral health education and motivation
Intensive oral health education and motivation
Sponsored by
Jordan University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dental Caries focused on measuring Oral health status, Dental treatment needs, Barriers to dental care, Children at social homes

Eligibility Criteria

4 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy children living in social homes among age group specified

Exclusion Criteria:

  • Children with poor behavior

Sites / Locations

  • Jordan University of Science and Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Study group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Measure of dental caries
Decayed, missing, filled teeth
Gingival health
Presence or absence of gingival inflammation
Oral hygiene
Presence or absence of dental plaque

Secondary Outcome Measures

Full Information

First Posted
March 19, 2020
Last Updated
March 27, 2021
Sponsor
Jordan University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT04317768
Brief Title
Effect of Oral Health Education on Oral Health Status, Treatment Needs and Barriers to Care
Official Title
The Effectiveness 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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
May 15, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jordan University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The oral health status (OHS) for children and adults is a reflection of the whole body general health status as well as the overall quality of life. Jordanian children have very poor oral hygiene parameters, and this is reflected as very high caries prevalence and poor gingival health conditions. Orphans and children who come from broken homes are suspected to have poorer oral health conditions from their peers in the public due to the different parameters that can affect their general health in whole and oral health in particular, and this could affect their quality of life. These parameters can be related to socioeconomic status, psychological and behavioral conditions, access to care and other factors. The role of tooth brushing in decreasing dental caries and enhancing the gingival health is well-established in the literature, and oral health education programs have proven to be effective in improving the oral health knowledge, attitude and behavior of children. These programs could be regarded as an effective measure to enhance the oral health status and establish good routines in childhood which is vital for optimum oral health and provision of lifelong protection against caries. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries, Gingivitis
Keywords
Oral health status, Dental treatment needs, Barriers to dental care, Children at social homes

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
The statistician is blinded to groups.
Allocation
Randomized
Enrollment
232 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Basic oral health education and motivation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intensive oral health education and motivation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measure of dental caries
Description
Decayed, missing, filled teeth
Time Frame
1 year
Title
Gingival health
Description
Presence or absence of gingival inflammation
Time Frame
1 year
Title
Oral hygiene
Description
Presence or absence of dental plaque
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy children living in social homes among age group specified Exclusion Criteria: Children with poor behavior
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ola Al-Batayneh
Organizational Affiliation
Jordan University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jordan University of Science and Technology
City
Irbid
ZIP/Postal Code
22110
Country
Jordan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Oral Health Education on Oral Health Status, Treatment Needs and Barriers to Care

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