Supernumerary TeethNCT03650634
Prevalence of Erupted Supernumerary Teeth Among a Group of Egyptian Children Aged From Six to Fifteen Years Old
An observational study of Supernumerary Teeth, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of this study is to assess the prevalence of erupted supernumerary teeth among a group of Egyptian children aged from 6-15 years old attending the Outpatients' clinic of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University. Read more about this study
- Who is it for?
- Ages 6 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Supernumerary Teeth
- How many people
- 604 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2019to 1 Sep 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 6 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Participants will be selected from the Outpatients' clinic of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University according to the eligibility criteria.
Who may be able to join
- Positive patient and parent acceptance for participation in the study.
- Patients who are medically free from any systemic disease.
- Children aged from 6 to 15 years old.
- Both sexes will be included.
Who cannot join
- Uncooperative children.
- Handicapped children.
- Children who refuse to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Erupted Supernumerary Teeth Among a Group of Egyptian Children Aged From Six to Fifteen Years Old: a Cross Sectional Study
The purpose of this study is to assess the prevalence of erupted supernumerary teeth among a group of Egyptian children aged from 6-15 years old attending the Outpatients' clinic of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University.
Read the detailed description
- Clinical examination will be done for participants fulfilling the inclusion criteria after obtaining an informed consent from parents for acceptance of participation in the study after explaining the purpose of the study and the measures that will be held to the child.
- A custom made examination chart (Appendix 1) will be filled out, during face to face interview with the child and/or his parents, including: date, name, age, gender, address, medical history and previous dental treatment followed by clinical examination to detect the presence of supernumerary teeth.
- The presence of supernumerary teeth and its type and location will be recorded in the examination chart.
- Each child with supernumerary teeth will be given a letter, translated into Arabic, outlining his dental status to inform the parents about the condition and the need for treatment
Examination chart (Appendix 1 ):
Date :...................................................................
Personal information:
Name............................................. Age..........................................
Gender :.......................................... Address : ................................
Phone number : .................................................. Medical history: ......................................................... ..................................................................................
Previous dental history: ...........................................
......................................................................................
Clinical examination :
Supernumerary teeth: presence / absence Location : ........................................... Type :..................................................
- Conditions
- Supernumerary Teeth
- Keywords
- supernumerary tooth, hyperdontia, mesiodens, paramolar
- Medical subject headings
- Tooth, Supernumerary
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of supernumerary teeth
Measuring device: clinical examination. Measuring unit : binary (yes or/ no ).
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 Aug 2018
- Study start1 May 2019
- Primary completion30 Jul 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supernumerary TeethStudies 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
- 604 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riham Ahmed El-Halafawey Anwar Emam, Cairo University
- Investigators
- Randa Youssef, Ass.prof., Study director, Cairo UniversityRasha Hatem, Lecturer, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03650634
- Sponsor's protocol ID
- CEBD-CU-2018-08-16
- Status last verified
- Jul 2020
- First submitted
- 27 Aug 2018
- Last updated
- 21 Jul 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 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Erupted Supernumerary Teeth Among a Group of Egyptian Children Aged From Six to Fifteen Years Old: a Cross Sectional Study
- ClinicalTrials.gov ID
- NCT03650634
- Acronym / sponsor ID
- CEBD-CU-2018-08-16
- Conditions
- Supernumerary Teeth
- Keywords
- supernumerary tooth, hyperdontia, mesiodens, paramolar
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 604 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 29 Aug 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 purpose of this study is to assess the prevalence of erupted supernumerary teeth among a group of Egyptian children aged from 6-15 years old attending the Outpatients' clinic of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University.
Detailed description
- Clinical examination will be done for participants fulfilling the inclusion criteria after obtaining an informed consent from parents for acceptance of participation in the study after explaining the purpose of the study and the measures that will be held to the child.
- A custom made examination chart (Appendix 1) will be filled out, during face to face interview with the child and/or his parents, including: date, name, age, gender, address, medical history and previous dental treatment followed by clinical examination to detect the presence of supernumerary teeth.
- The presence of supernumerary teeth and its type and location will be recorded in the examination chart.
- Each child with supernumerary teeth will be given a letter, translated into Arabic, outlining his dental status to inform the parents about the condition and the need for treatment
Examination chart (Appendix 1 ):
Date :...................................................................
Personal information:
Name............................................. Age..........................................
Gender :.......................................... Address : ................................
Phone number : .................................................. Medical history: ......................................................... ..................................................................................
Previous dental history: ...........................................
......................................................................................
Clinical examination :
Supernumerary teeth: presence / absence Location : ........................................... Type :..................................................
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Participants will be selected from the Outpatients' clinic of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University according to the eligibility criteria.
Key inclusion criteria (4 listed)
- Positive patient and parent acceptance for participation in the study.
- Patients who are medically free from any systemic disease.
- Children aged from 6 to 15 years old.
- Both sexes will be included.
Key exclusion criteria (3 listed)
- Uncooperative children.
- Handicapped children.
- Children who refuse to participate in the study.
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 supernumerary teeth
Time frame: 6 months
Measuring device: clinical examination. Measuring unit : binary (yes or/ no ).
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 21 Jul 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.
Randa Youssef, Ass.prof. study director
Cairo University
Rasha Hatem, Lecturer study director
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 Supernumerary Teeth, 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 4 inclusion and 3 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 21 Jul 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?
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?
prevalence of supernumerary teeth (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 21 Jul 2020.