Dental Caries in ChildrenNCT05652231
Assessment of Dental Caries Among a Group of Institutionalized Orphan Children Compared to Parented School Children
An observational study of Dental Caries in Children, run by Ahram Canadian University at 1 site in Egypt.
Trial summary
Children from two orphanages will be examined for dental caries experience, in comparison to parented school children. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children
- What is being tested?
- caries assessment
- How many people
- 156 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to 1 Jan 2023
- How long will I take part?
- 1 Day
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: apparently healthy children aged from six to12 years old
Who may be able to join
- apparently healthy children aged from six to12 years old
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Children from two orphanages will be examined for dental caries experience, in comparison to parented school children.
Read the detailed description
A total of 156 children were included in this study, they were, residing in governmental orphanage, non-governmental orphanage and parented children attending primary school. Written informed consent was obtained prior to the start of the study, form legal guardians or child's parent. Dental examination was carried out on an ordinary chair beside a window on day light. DMF and def indices were used to assess dental caries for primary and permanent teeth. Also, unmet treatment need index, care index and significant caries index were calculated.
- Conditions
- Dental Caries in Children
- Being tested
- caries assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caries assessmentDiagnostic test
the child will examined for dental caries, caries prevalence, caries indices (def and DMF, or DMF)
| Study group | Role | What they receive |
|---|---|---|
| School children (control group) | parented school children (control group) Receives: Diagnostic Test: caries assessment | |
| Non-Governmental orphanage children (exposed group 1) | Not described Receives: Diagnostic Test: caries assessment | |
| Governmental orphanage children (exposed group 2) | Not described Receives: Diagnostic Test: caries assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
caries experience
measured using DMF/ def index
Measured: baseline record
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start1 Nov 2022
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental Caries in ChildrenStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 156 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ahram Canadian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mennat Allah Ashraf A.Elsabour, Ahram Canadian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05652231
- Sponsor's protocol ID
- ACU 111
- Status last verified
- Mar 2023
- First submitted
- 6 Dec 2022
- Last updated
- 6 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khattab NMA, Abd-Elsabour MAA. Assessment of dental caries among a group of institutionalized orphan children compared to parented school children: case-control study. BMC Oral Health. 2023 Apr 5;23(1):202. doi: 10.1186/s12903-023-02915-1.
PubMed 37020200
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Dental Caries Among a Group of Institutionalized Orphan Children Compared to Parented School Children
- ClinicalTrials.gov ID
- NCT05652231
- Acronym / sponsor ID
- ACU 111
- Conditions
- Dental Caries in Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Ahram Canadian UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 15 Dec 2022 (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.
Children from two orphanages will be examined for dental caries experience, in comparison to parented school children.
Detailed description
A total of 156 children were included in this study, they were, residing in governmental orphanage, non-governmental orphanage and parented children attending primary school. Written informed consent was obtained prior to the start of the study, form legal guardians or child's parent. Dental examination was carried out on an ordinary chair beside a window on day light. DMF and def indices were used to assess dental caries for primary and permanent teeth. Also, unmet treatment need index, care index and significant caries index were calculated.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| School children (control group) | – | Diagnostic Test: caries assessmentparented school children (control group) |
| Non-Governmental orphanage children (exposed group 1) | – | Diagnostic Test: caries assessment |
| Governmental orphanage children (exposed group 2) | – | Diagnostic Test: caries assessment |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- apparently healthy children aged from six to12 years old
Key inclusion criteria (1 listed)
- apparently healthy children aged from six to12 years old
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| caries assessmentthe child will examined for dental caries, caries prevalence, caries indices (def and DMF, or DMF) | Diagnostic test | Governmental orphanage children (exposed group 2), Non-Governmental orphanage children (exposed group 1), School children (control group) |
Primary outcome
caries experience
Time frame: baseline record
measured using DMF/ def index
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 6 Mar 2023.
- Derived from this study: PubMed 37020200Khattab NMA, Abd-Elsabour MAA. Assessment of dental caries among a group of institutionalized orphan children compared to parented school children: case-control study. BMC Oral Health. 2023 Apr 5;23(1):202. doi: 10.1186/s12903-023-02915-1.
- 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.
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 Dental Caries in Children, run by Ahram Canadian 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 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 6 Mar 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?
caries experience (time frame: baseline record). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05652231, which also lists 1 linked publication.
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 6 Mar 2023.