Dental CariesNCT04317768
Effect of Oral Health Education on Oral Health Status, Treatment Needs and Barriers to Care
A study testing Basic oral health education and motivation and Intensive oral health education and motivation in people with Dental Caries and Gingivitis, run by Jordan University of Science and Technology at 1 site in Jordan.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Gingivitis
- What is being tested?
- Basic oral health education and motivation and Intensive oral health education and motivation
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 1 siteJordan
- Study dates
- 1 Feb 2019to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children living in social homes among age group specified
Who cannot join
- Children with poor behavior
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Dental Caries, Gingivitis
- Being tested
- Basic oral health education and motivation, Intensive oral health education and motivation
- Keywords
- Oral health status, Dental treatment needs, Barriers to dental care, Children at social homes
- Medical subject headings
- Dental Caries, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basic oral health education and motivationBehavioural
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.
Intensive oral health education and motivationBehavioural
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 | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Basic oral health education and motivation; Behavioral: 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. Receives: Behavioral: Basic oral health education and motivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of dental caries
Decayed, missing, filled teeth
Measured: 1 year
Gingival health
Presence or absence of gingival inflammation
Measured: 1 year
Oral hygiene
Presence or absence of dental plaque
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start1 Feb 2019
- Primary completion15 May 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ola Al-Batayneh, Principal investigator, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04317768
- Sponsor's protocol ID
- JUST 293-2018
- Status last verified
- Mar 2021
- First submitted
- 19 Mar 2020
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04317768
- Acronym / sponsor ID
- JUST 293-2018
- Conditions
- Dental Caries, Gingivitis
- Keywords
- Oral health status, Dental treatment needs, Barriers to dental care, Children at social homes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Jordan University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 23 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Behavioral: Basic oral health education and motivation, Behavioral: Intensive oral health education and motivationThey 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. |
| Control group | Other | Behavioral: Basic oral health education and motivationThey 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. |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy children living in social homes among age group specified
Key exclusion criteria (1 listed)
- Children with poor behavior
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Basic oral health education and motivationSubjects 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. | Behavioural | Control group, Study group |
| Intensive oral health education and motivationSubjects 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. | Behavioural | Study group |
Primary outcome
Measure of dental caries
Time frame: 1 year
Decayed, missing, filled teeth
Gingival health
Time frame: 1 year
Presence or absence of gingival inflammation
Oral hygiene
Time frame: 1 year
Presence or absence of dental plaque
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ola Al-Batayneh principal investigator
Jordan University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Basic oral health education and motivation and Intensive oral health education and motivation in people with Dental Caries and Gingivitis, run by Jordan University of Science and Technology at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of dental caries (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2021.