Dental Caries in ChildrenNCT03573180
Prevalence of Dental Caries Among a Group of Egyptian Children Using CAST Index
An observational study of Dental Caries in Children, run by Cairo University.
Trial summary
The aim of this study is to assess the prevalence of dental caries using CAST index among a group of Egyptian children in primary dentition stage. Egyptian children aging from three to six years old attending the Outpatients' Clinic of both of Pediatric Dentistry Department, Faculty of Dentistry, Misr University for… Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2018to 1 Jun 2019
- 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 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children will be selected from Outpatients' clinic of both of Pediatric Dentistry Department, Faculty of Dentistry, Misr University for Science and Technology and the Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University according to the eligibility criteria
Who may be able to join
- Parental or guardian acceptance for participation in the study.
- Children who are medically free from any systemic diseases.
- Children with primary dentition aging from 3-6 years old.
- Both genders.
Who cannot join
- Uncooperative child.
Trial locations and contacts
No sites are listed yet.
Adel Hamza contact
About this study
Official title: Prevalence of Dental Caries Among a Group of Egyptian Children Using Caries Assessment Spectrum and Treatment Index:A Cross Sectional Study
The aim of this study is to assess the prevalence of dental caries using CAST index among a group of Egyptian children in primary dentition stage.
Egyptian children aging from three to six years old attending the Outpatients' Clinic of both of Pediatric Dentistry Department, Faculty of Dentistry, Misr University for Science and Technology and the Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University will be examined using Caries Assessment Spectrum and Treatment
Read the detailed description
- A custom made examination chart (Appendix 1) will be filled for each child including date, name, age, address, gender, medical history and any previous dental treatment. Parents' data includes: level of education and oral hygiene level.
- Prior to performing dental examination, the child will be asked to rinse his mouth with tap water and the teeth will be cleaned with cotton.
- The examiner will carefully inspect all surfaces of the teeth.
- All the primary teeth will be evaluated using CAST index as shown in Table 1.
- Each child will be given two printed sheets translated into Arabic, of his diagnosed caries status, the oral hygiene measures needed to inform the parents about the oral health status and how to keep good oral health and to indicate the need for treatment for children diagnosed with dental caries, and dietary bad habits that should be avoided to prevent caries occurrence.
Examination chart
Date:
Personal information:
Name: Age: Gender:
Address:
Medical history:
Parents' level of education:
Dental history:
Clinical examination:
E D C B A A B C D E
E D C B A A B C D E
Table 1: Caries Assessment Spectrum and Treatment(CAST) index Cast codes characteristics Code Description Concept of Health Sound 0 No visible evidence of a distinct •carious lesion is present Healthy
- Sealant 1 Pits and/or fissures are at least partially covered with a sealant material
- Restored 2 A cavity is restored with an (in)direct restorative material
- Enamel 3 Distinct visual change in enamel only. A clear caries related discoloration is visible, with or without localized enamel breakdown Reversible premorbidity
- Dentin 4 Internal caries-related discoloration in dentine. The discolored dentine is visible through enamel which may or may not exhibit a visible localized breakdown of enamel Morbidity
- 5 Distinct cavitation into dentine. The pulp chamber is intact
- Pulp 6 Involvement of the pulp chamber. Distinct cavitation reaching the pulp chamber or only root fragments are present Serious morbidity
- Abscess/ fistula 7 A pus containing swelling or a pus releasing sinus tract related to a tooth with pulpal involvement
- Lost 8 The tooth has been removed because of dental caries Mortality
- Other 9 Does not correspond to any of the other descriptions ■Severity according to CAST index:
Comments:
Dental caries: Present Absent Severity: ……………………….. (Appendix 1)
- Conditions
- Dental Caries in Children
- Keywords
- CAST index, prevalence of caries, primary dentition caries
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of dental caries using CAST index (Frencken et al., 2013)
Measuring device:CAST index (Frencken et al., 2013) Measuring unit: Score (0-9)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start1 Jul 2018 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion1 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Caries in ChildrenStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Adel Abd El-Hafez Osman Hamza, Cairo University
- Investigators
- Amr Ezzat, Professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03573180
- Sponsor's protocol ID
- CEBD-CU-2018-06-68
- Status last verified
- Jun 2018
- First submitted
- 18 Jun 2018
- Last updated
- 29 Jun 2018
- 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 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Dental Caries Among a Group of Egyptian Children Using Caries Assessment Spectrum and Treatment Index:A Cross Sectional Study
- ClinicalTrials.gov ID
- NCT03573180
- Acronym / sponsor ID
- CEBD-CU-2018-06-68
- Conditions
- Dental Caries in Children
- Keywords
- CAST index, prevalence of caries, primary dentition caries
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 1 Jun 2019 (estimated)
- First posted
- 29 Jun 2018 (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.
The aim of this study is to assess the prevalence of dental caries using CAST index among a group of Egyptian children in primary dentition stage.
Egyptian children aging from three to six years old attending the Outpatients' Clinic of both of Pediatric Dentistry Department, Faculty of Dentistry, Misr University for Science and Technology and the Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University will be examined using Caries Assessment Spectrum and Treatment
Detailed description
- A custom made examination chart (Appendix 1) will be filled for each child including date, name, age, address, gender, medical history and any previous dental treatment. Parents' data includes: level of education and oral hygiene level.
- Prior to performing dental examination, the child will be asked to rinse his mouth with tap water and the teeth will be cleaned with cotton.
- The examiner will carefully inspect all surfaces of the teeth.
- All the primary teeth will be evaluated using CAST index as shown in Table 1.
- Each child will be given two printed sheets translated into Arabic, of his diagnosed caries status, the oral hygiene measures needed to inform the parents about the oral health status and how to keep good oral health and to indicate the need for treatment for children diagnosed with dental caries, and dietary bad habits that should be avoided to prevent caries occurrence.
Examination chart
Date:
Personal information:
Name: Age: Gender:
Address:
Medical history:
Parents' level of education:
Dental history:
Clinical examination:
E D C B A A B C D E
E D C B A A B C D E
Table 1: Caries Assessment Spectrum and Treatment(CAST) index Cast codes characteristics Code Description Concept of Health Sound 0 No visible evidence of a distinct •carious lesion is present Healthy
- Sealant 1 Pits and/or fissures are at least partially covered with a sealant material
- Restored 2 A cavity is restored with an (in)direct restorative material
- Enamel 3 Distinct visual change in enamel only. A clear caries related discoloration is visible, with or without localized enamel breakdown Reversible premorbidity
- Dentin 4 Internal caries-related discoloration in dentine. The discolored dentine is visible through enamel which may or may not exhibit a visible localized breakdown of enamel Morbidity
- 5 Distinct cavitation into dentine. The pulp chamber is intact
- Pulp 6 Involvement of the pulp chamber. Distinct cavitation reaching the pulp chamber or only root fragments are present Serious morbidity
- Abscess/ fistula 7 A pus containing swelling or a pus releasing sinus tract related to a tooth with pulpal involvement
- Lost 8 The tooth has been removed because of dental caries Mortality
- Other 9 Does not correspond to any of the other descriptions ■Severity according to CAST index:
Comments:
Dental caries: Present Absent Severity: ……………………….. (Appendix 1)
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children will be selected from Outpatients' clinic of both of Pediatric Dentistry Department, Faculty of Dentistry, Misr University for Science and Technology and the Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University according to the eligibility criteria
Key inclusion criteria (4 listed)
- Parental or guardian acceptance for participation in the study.
- Children who are medically free from any systemic diseases.
- Children with primary dentition aging from 3-6 years old.
- Both genders.
Key exclusion criteria (1 listed)
- Uncooperative child.
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
Prevalence of dental caries using CAST index (Frencken et al., 2013)
Time frame: 6 months
Measuring device:CAST index (Frencken et al., 2013) Measuring unit: Score (0-9)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2018.
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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.
Adel Hamza contact
Amr Ezzat, Professor study director
Cairo University
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Caries in Children, run by Cairo University.
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 4 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: status not confirmed, as of the sponsor's last update on 29 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Ad Hamza, Bds (01062315566, aya.adel@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of dental caries using CAST index (Frencken et al., 2013) (time frame: 6 months). 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 29 Jun 2018.