Destructive Attachment of Labial FrenumdiastemaNCT04244903
Prevalence of MLFA Types and MD in Egyptian Children With Erupted Canines
An observational study of Destructive Attachment of Labial Frenum, run by Cairo University at 2 sites in Egypt.
Trial summary
Descriptive observational cross sectional study Outpatient at faculty of dentistry Cairo university pediatric dentistry department clinic with midline diastema and fully erupted canines will be examined and assess type of frenal attachment to see if correlation present or not Read more about this study
- Who is it for?
- Ages 9 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Destructive Attachment of Labial Frenum
- How many people
- 275 participants
- Where
- 2 sitesEgypt
- Study dates
- Jun 2022to Aug 2022
- 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 9 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: This study will be conducted among Egyptian children with fully erupted canines, who regularly attend the outpatient clinic of pediatric dentistry department, Cairo University.
Who may be able to join
- Systemically healthy children
- Egyptian children with fully erupted canines
- Patient presented for routine evaluation or treatment
Who cannot join
- Children who exhibited congenital anomalies or orofacial defects
- Children with previous trauma in frenal area which affect its morphology
- Children have previous surgical intervention in labial frenum or in the maxillary anterior region.
- Children have any syndromes or habits that affect the anterior maxillary region.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Faculty of Dentistry Cairo University
Cairo, Giza Governorate
Asmaa Saad, Master, 01014007249, asmaa_saad@dentistry.cu.edu.eg
- Enrolling by invitation
Asmaa Ahmed saad
Giza
About this study
Official title: Prevalence of Maxillary Labial Frenal Attachments Types and Midline Diastema in Egyptian Children With Fully Erupted Maxillary Permanent Canines
Descriptive observational cross sectional study Outpatient at faculty of dentistry Cairo university pediatric dentistry department clinic with midline diastema and fully erupted canines will be examined and assess type of frenal attachment to see if correlation present or not
- Conditions
- Destructive Attachment of Labial Frenum
- Keywords
- Midline diastema, Prevalence, Maxillary frenal types
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Midline diastema
measuring diastema in millimeters using calibrated ruler
Measured: 1 year
Secondary outcomes (1)
Frenal attachment types
Direct visual method
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study startJun 2022 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Destructive Attachment of Labial FrenumStudies 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
- 275 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Ahmed Saad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04244903
- Sponsor's protocol ID
- CEBD-CU-2019-12-05
- Acronym
- diastema
- Status last verified
- Jun 2022
- First submitted
- 25 Jan 2020
- Last updated
- 2 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Maxillary Labial Frenal Attachments Types and Midline Diastema in Egyptian Children With Fully Erupted Maxillary Permanent Canines
- ClinicalTrials.gov ID
- NCT04244903
- Acronym / sponsor ID
- diastema / CEBD-CU-2019-12-05
- Conditions
- Destructive Attachment of Labial Frenum
- Keywords
- Midline diastema, Prevalence, Maxillary frenal types
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 275 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 28 Jan 2020 (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.
Descriptive observational cross sectional study Outpatient at faculty of dentistry Cairo university pediatric dentistry department clinic with midline diastema and fully erupted canines will be examined and assess type of frenal attachment to see if correlation present or not
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 9 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- This study will be conducted among Egyptian children with fully erupted canines, who regularly attend the outpatient clinic of pediatric dentistry department, Cairo University.
Key inclusion criteria (3 listed)
- Systemically healthy children
- Egyptian children with fully erupted canines
- Patient presented for routine evaluation or treatment
Key exclusion criteria (4 listed)
- Children who exhibited congenital anomalies or orofacial defects
- Children with previous trauma in frenal area which affect its morphology
- Children have previous surgical intervention in labial frenum or in the maxillary anterior region.
- Children have any syndromes or habits that affect the anterior maxillary region.
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
Incidence of Midline diastema
Time frame: 1 year
measuring diastema in millimeters using calibrated ruler
1 secondary outcome
Frenal attachment types
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Individual participant dataSharing planned: Undecided
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Destructive Attachment of Labial Frenum, run by Cairo University at 2 sites 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 3 inclusion and 4 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 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 33,saad ibn aby waqas street, faisal, giza (01014007249, Asmaa_saad@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Midline diastema (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 2 Jun 2022.