Dental CariesNCT04183777
Assessment of the Age, Reasons, Oral Health Status and Dental Treatment Needs of Children in Their First Dental Visit
An observational study of Dental Caries and Parents, run by Cairo University at 1 site in Egypt.
Trial summary
to asses the age, reasons, oral health status and dental treatment needs of children in their first dental visit. Read more about this study
- Who is it for?
- Ages 3 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Parents, Parenting
- How many people
- 1 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2020to 1 Mar 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 3 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: We are going to provide each parent or guardian whose children fulfilling the inclusion criteria attending to Department of Paediatrics Dentistry at Cairo University to fulfil questionnaire which include multiple MCQ questions. We will explain to the parents and legal guardians the aim of the study without any guiding to prevent any information bias which may occur. The questionnaire will be given before the treatment and will be collected after it. Any children whose records will include missing information will be excluded from the study.
Who may be able to join
- Children with Primary and mixed dentition.
- Children visiting the dentist for the first time (first dental visit
Who cannot join
- Children with systemic diseases or physical and mental problem.
- Children whose parents refuse participation
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Aya Abdelmawgoud Elsanhouri
El-Sheikh Zayed City, Giza Governorate, 002
About this study
to asses the age, reasons, oral health status and dental treatment needs of children in their first dental visit.
Read the detailed description
We are going to provide each parent or guardian whose children fulfilling the inclusion criteria attending to Department of Paediatrics Dentistry at Cairo University to fulfil questionnaire which include multiple MCQ questions. The state of oral health and dental treatment needs will be assessed based on clinical examination, according to recommendations of the World Health Organization. The total number of teeth and number of teeth affected by decay (d, D) in every child will be recorded. The intensity of caries will be estimated based on the average dmf/DMF number, i.e. caries intensity index.
The dental treatment needs of each child will be assessed based on the following categories:
- None: no restorative treatment required.
- Simple: preventive treatment required, such as scaling and brushing, oral hygiene instruction (OHI), application of topical fluoride and fissure sealant.
- Moderate: one or more of teeth require one or two surface restoration.
- Complex: one or more teeth require three or four surface restoration / stainless steel crown, endodontic therapy and crown, and /or extraction(7) .
Reasons for first dental visit will be categories as :
- Adaptive visit dental check-up preventive purpose. b. Tooth pain. c. Emergency case (tooth injury, abscess, infection). d. Decay noted by parent.
- Any Other. We will explain to the parents and legal guardians the aim of the study without any guiding to prevent any information bias which may occur. The questionnaire will be given before the treatment and will be collected after it. Any children whose records will include missing information will be excluded from the study.
- Conditions
- Dental Caries, Parents, Parenting, Pain
- Keywords
- first dental visit, oral health, reasons of first dental visit, dental treatment needs
- Medical subject headings
- Dental Caries, Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
reasons for the first dental visit.
There are different reasons for the first dental visit these reasons may be due to a- Adaptive visit dental check-up preventive purpose. b. Tooth pain. c. Emergency case (tooth injury, abscess, infection). d. Decay noted by parent.
- Any Other.
Caregiver will be asked to fill a questionnaire include multiple reasons. The parents or Guardian select the most chief complain for coming to the first dental visit. And after selection the most common reason will determine.
Measured: 1 year
Secondary outcomes (3)
age
Caregiver will be asked to fill a questionnaire include multiple age. The parents or Guardian select the most optimal age for the first dental visit from their point of view .
Measured: 1 years
oral health
The state of oral health will be assessed based on clinical examination, according to recommendations of the World Health Organization. The total number of teeth and number of teeth affected by decay (d, D) in every child will be recorded. The intensity of caries will be estimated based on the average dmf/DMF number, i.e. caries intensity index.
Measured: 1 years
dental treatment needs
Dental treatment needs will be assessed based on clinical examination, according to recommendations of the World Health Organization.
The dental treatment needs of each child will be assessed based on the following categories:
- None: no restorative treatment required.
- Simple: preventive treatment required, such as scaling and brushing, oral hygiene instruction (OHI), application of topical fluoride and fissure sealant.
- Moderate: one or more of teeth require one or two surface restoration. D-Complex: one or more teeth require three or four surface restoration / stainless steel crown, endodontic therapy and crown, and /or extraction.
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start1 Mar 2020 (estimated)
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Mar 2021 (estimated)
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.
- 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, aya abd el mawgoud mohamed elsanhouri, Cairo University
- Investigators
- aya elsnhouri, bachelor, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04183777
- Sponsor's protocol ID
- Cairo university ,Egypt
- Status last verified
- Dec 2019
- First submitted
- 26 Nov 2019
- Last updated
- 5 Feb 2020
- 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 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Age, Reasons, Oral Health Status and Dental Treatment Needs of Children in Their First Dental Visit
- ClinicalTrials.gov ID
- NCT04183777
- Acronym / sponsor ID
- Cairo university ,Egypt
- Conditions
- Dental Caries, Parents, Parenting, Pain
- Keywords
- first dental visit, oral health, reasons of first dental visit, dental treatment needs
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 3 Dec 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.
to asses the age, reasons, oral health status and dental treatment needs of children in their first dental visit.
Detailed description
We are going to provide each parent or guardian whose children fulfilling the inclusion criteria attending to Department of Paediatrics Dentistry at Cairo University to fulfil questionnaire which include multiple MCQ questions. The state of oral health and dental treatment needs will be assessed based on clinical examination, according to recommendations of the World Health Organization. The total number of teeth and number of teeth affected by decay (d, D) in every child will be recorded. The intensity of caries will be estimated based on the average dmf/DMF number, i.e. caries intensity index.
The dental treatment needs of each child will be assessed based on the following categories:
- None: no restorative treatment required.
- Simple: preventive treatment required, such as scaling and brushing, oral hygiene instruction (OHI), application of topical fluoride and fissure sealant.
- Moderate: one or more of teeth require one or two surface restoration.
- Complex: one or more teeth require three or four surface restoration / stainless steel crown, endodontic therapy and crown, and /or extraction(7) .
Reasons for first dental visit will be categories as :
- Adaptive visit dental check-up preventive purpose. b. Tooth pain. c. Emergency case (tooth injury, abscess, infection). d. Decay noted by parent.
- Any Other. We will explain to the parents and legal guardians the aim of the study without any guiding to prevent any information bias which may occur. The questionnaire will be given before the treatment and will be collected after it. Any children whose records will include missing information will be excluded from the study.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- We are going to provide each parent or guardian whose children fulfilling the inclusion criteria attending to Department of Paediatrics Dentistry at Cairo University to fulfil questionnaire which include multiple MCQ questions. We will explain to the parents and legal guardians the aim of the study without any guiding to prevent any information bias which may occur. The questionnaire will be given before the treatment and will be collected after it. Any children whose records will include missing information will be excluded from the study.
Key inclusion criteria (2 listed)
- Children with Primary and mixed dentition.
- Children visiting the dentist for the first time (first dental visit
Key exclusion criteria (2 listed)
- Children with systemic diseases or physical and mental problem.
- Children whose parents refuse participation
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
reasons for the first dental visit.
Time frame: 1 year
There are different reasons for the first dental visit these reasons may be due to a- Adaptive visit dental check-up preventive purpose. b. Tooth pain. c. Emergency case (tooth injury, abscess, infection). d. Decay noted by parent. e. Any Other. Caregiver will be asked to fill a questionnaire include multiple reasons. The parents or Guardian select the most chief complain for coming to the first dental visit. And after selection the most common reason will determine.
3 secondary outcomes
age
Time frame: 1 years
oral health
Time frame: 1 years
dental treatment needs
Time frame: 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
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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.
aya elsnhouri, bachelor principal investigator
Cairo University
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 Dental Caries and Parents, 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 2 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: status not confirmed, as of the sponsor's last update on 5 Feb 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact aya elsahouri, bachelor (00201062141215, drayaelsanhory@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reasons for the first dental visit. (time frame: 1 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 5 Feb 2020.