Oral Health KnowledgeNCT03919903
Parent's Knowledge, Attitude and Practices Towards Oral Health of Their Children With Primary Dentition: A Cross-sectional Study
An observational study of Oral Health Knowledge, run by Cairo University at 1 site in Egypt.
Trial summary
Study aims to assess Parents Knowledge, Attitude and Practices towards Oral Health of their Children with Primary Teeth. Read more about this study
- Who is it for?
- Ages 1 year to 8 years
- Conditions the study is for
- Oral Health Knowledge
- How many people
- 301 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2020to 1 Jan 2021
- Phase
- Observational
- 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 1 year to 8 years
- All sexes
- Child
Study population: Parents of children with primary dentition
Who may be able to join
- Healthy children and their parents.
- Children with primary dentition.
Who cannot join
- Parents refuse to participate.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Pediatric Dentistry and Dental public Health, Cairo University
Cairo
About this study
Study aims to assess Parents Knowledge, Attitude and Practices towards Oral Health of their Children with Primary Teeth.
Read the detailed description
Dental caries is a chronic slowly progressing localized destruction of dental hard tissues by the acidic products formed as result of carbohydrates fermentation by bacteria due to disturbance in equilibrium between tooth minerals and plaque products through time. (Trindade et al., 2014) It's a worldwide disease affecting all ages both sexes with different socioeconomic levels. Dental caries commonly affects children and adversely affects their quality of life and so their weight and growth if left untreated (Gokhale and Nuvvula, 2015). The environmental factor is a very valuable factor affecting dental caries especially the mother and the family as whole, the family habits are directly influencing their children (Suma G and Anisha P, 2017). As parents are the primary decision makers for children and their first role models, their oral health knowledge, attitude and practice as well as habits influence their children (Dikshit et al., 2018).
There is lack of data about parent's oral health knowledge, attitude and practice and their implications on their children in Egypt.
Acquiring information about oral health knowledge of parents, will help identifying those children who are at risk of dental caries consequently it will be possible to offer the proper preventive and curative measures for them.
So, we need to know the effect of oral health knowledge, attitude and practice (KAP) of parents on caries prevalence of their children.
- Conditions
- Oral Health Knowledge
What is being measured
The primary outcome is the main question the study is designed to answer.
Parents Oral Health Knowledge, Attitude and Practice (KAP)
Questionnaire is the measurement tool for the primary outcome, questionnaires will be admitted to the parents in the waiting area of the diagnostic clinic of Pediatric dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University.The questionnaire consists of 28 questions; 10 related to knowledge, 6 to attitude, 8 to practice and 4 general questions. The response will be assessed by using a scoring system, where scores are based on correct answers. For the knowledge and practice items, the right answer is coded as 1 and the wrong answer as 0. For attitude items score 1 indicates a positive attitude, while score 0 indicates a negative attitude. The individual scores will then be summed up to yield a total score. Maximum possible score will be 10, 6 and 8 for KAP respectively. Mean Score of <40% and≥ 40 % are considered as inadequate and adequate performance respectively. (Dikshit et al., 2018) The questionnaire was translated in Arabic language.
Measured: one year
Secondary outcomes (1)
Caries Prevalence in their children
Caries Prevalence in the children will be assessed by clinical examination. Examination will be performed at the diagnostic clinic of the Pediatric dentistry department, Faculty of Dentistry, Cairo University. Patient assessment chart will be used for recording the oral assessment data. The oral assessment of every child will be done by a single operator under good lighting condition using mouth mirror and probe to detect the presence of carious (whether smooth or pits and fissure caries), missed (extracted) and filled teeth (Cypriano et al., 2005).
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start1 Nov 2020
- Primary completion1 Nov 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Health KnowledgeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mennatallah Ahmed Mohamed Helal, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03919903
- Sponsor's protocol ID
- Parent's Oral Health Knowledge
- Status last verified
- May 2023
- First submitted
- 15 Apr 2019
- Last updated
- 19 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent's Knowledge, Attitude and Practices Towards Oral Health of Their Children With Primary Dentition: A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT03919903
- Acronym / sponsor ID
- Parent's Oral Health Knowledge
- Conditions
- Oral Health Knowledge
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 18 Apr 2019 (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.
Study aims to assess Parents Knowledge, Attitude and Practices towards Oral Health of their Children with Primary Teeth.
Detailed description
Dental caries is a chronic slowly progressing localized destruction of dental hard tissues by the acidic products formed as result of carbohydrates fermentation by bacteria due to disturbance in equilibrium between tooth minerals and plaque products through time. (Trindade et al., 2014) It's a worldwide disease affecting all ages both sexes with different socioeconomic levels. Dental caries commonly affects children and adversely affects their quality of life and so their weight and growth if left untreated (Gokhale and Nuvvula, 2015). The environmental factor is a very valuable factor affecting dental caries especially the mother and the family as whole, the family habits are directly influencing their children (Suma G and Anisha P, 2017). As parents are the primary decision makers for children and their first role models, their oral health knowledge, attitude and practice as well as habits influence their children (Dikshit et al., 2018).
There is lack of data about parent's oral health knowledge, attitude and practice and their implications on their children in Egypt.
Acquiring information about oral health knowledge of parents, will help identifying those children who are at risk of dental caries consequently it will be possible to offer the proper preventive and curative measures for them.
So, we need to know the effect of oral health knowledge, attitude and practice (KAP) of parents on caries prevalence of their children.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 year to 8 years
- Sex
- All
- Age groups
- Child
- Study population
- Parents of children with primary dentition
Key inclusion criteria (2 listed)
- Healthy children and their parents.
- Children with primary dentition.
Key exclusion criteria (1 listed)
- Parents refuse to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Parents Oral Health Knowledge, Attitude and Practice (KAP)
Time frame: one year
Questionnaire is the measurement tool for the primary outcome, questionnaires will be admitted to the parents in the waiting area of the diagnostic clinic of Pediatric dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University.The questionnaire consists of 28 questions; 10 related to knowledge, 6 to attitude, 8 to practice and 4 general questions. The response will be assessed by using a scoring system, where scores are based on correct answers. For the knowledge and practice items, the right answer is coded as 1 and the wrong answer as 0. For attitude items score 1 indicates a positive attitude, while score 0 indicates a negative attitude. The individual scores will then be summed up to yield a total score. Maximum possible score will be 10, 6 and 8 for KAP respectively. Mean Score of <40% and≥ 40 % are considered as inadequate and adequate performance respectively. (Dikshit et al., 2018) The questionnaire was translated in Arabic language.
1 secondary outcome
Caries Prevalence in their children
Time frame: one year
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 19 May 2023.
- Evaluation of Knowledge, Attitude and Practices of Parents toward their Children Oral Health Compared with their Dental Caries statusLink provided by the sponsor.
- Knowledge, Attitudes And Practices of Parents Regarding Oral Health and Its Correlation with Dental Caries Status of Their Children: A Cross Sectional StudyLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Health Knowledge, run by Cairo University at 1 site in Egypt.
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 2 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 19 May 2023. 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 Egypt. 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?
Parents Oral Health Knowledge, Attitude and Practice (KAP) (time frame: one year). 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 19 May 2023.