Cleft Lip and PalateNCT04791813
Assessment of Maxillary Arch Depth and Width in a Group of Surgically Repaired Unilateral Cleft Lip and Palate Children Versus Normal Children .
An observational study of Cleft Lip and Palate, run by Cairo University.
Trial summary
The aim of the present study is to determine the effect of surgically repaired UCLP on dental arch dimensions and the need for orthodontic intervention in comparison with other healthy children , the presence of dental anomalies and the best possible standards of care among this group of Egyptian children. Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Cleft Lip and Palate
- What is being tested?
- Alginate impressions , Photographic data and panoramic radiographs .
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Mar 2022to Oct 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy Egyptian children aging from 9-12 years old
Who may be able to join
- Cooperative Egyptian children aging from ( 9-12) years.
- Medically free children.
- Children whose families accepts to participate in this study.
- Children with surgically repaired UCLP .
Who cannot join
- Children with previous untreated dental trauma.
- Children with previous orthodontic treatment
- Children with upper respiratory disease
- Children having any systemic diseases
- Intellectual disabilities or syndromes
- Congenital anomalies other than UCLP were excluded from the study .
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessment of Maxillary Arch Depth and Width in a Group of Surgically Repaired Unilateral Cleft Lip and Palate Egyptian Children Versus Normal Children .A Cross Sectional Study
The aim of the present study is to determine the effect of surgically repaired UCLP on dental arch dimensions and the need for orthodontic intervention in comparison with other healthy children , the presence of dental anomalies and the best possible standards of care among this group of Egyptian children.
Read the detailed description
In arranging to distinguish and implement the best possible standards of care for UCLP children by the pediatric dental practitioner, evaluation of early treatment results after essential surgical repair of cleft lip and palate with respect to arch dimensions is fundamental. Although the dental arch dimensions for these children have been evaluated in previous studies , few examiners in Egypt handled this issue Due to racial contrasts in improvement of the dental arch and growth .The deficiency of data in Egypt tending to this insufficient assemble of children presents a gap that prevents the transport of fitting dental care to them. This is considered objective to fulfill this gap by spotting the most characteristics of dental arch dimensions in surgically repaired UCLP children and compares them with those of sound, coordinating, non-cleft.
- Conditions
- Cleft Lip and Palate
- Being tested
- Alginate impressions , Photographic data and panoramic radiographs .
- Medical subject headings
- Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alginate impressions , Photographic data and panoramic radiographs .Other
Upper and lower alginate impressions will be poured and dental casts produced and converted to 3D digital cast using a 3D scanner-(3Shape )-the 3D data will be imported to a revers modeling software . Also Photographic data using Canon750 camera and panoramic radiographs to be taken.
| Study group | Role | What they receive |
|---|---|---|
| Exposure group | group of surgically treated unilateral cleft lip and palate Egyptian children aged 9_12years Receives: Other: Alginate impressions , Photographic data and panoramic radiographs . | |
| Control group | group of healthy Egyptian children aged 9_12years Receives: Other: Alginate impressions , Photographic data and panoramic radiographs . |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter canine maxillary arch width at the gingival level and 2. Inter molar maxillary arch Width at gingival level 3. Maxillary arch depth
Inter canine maxillary arch width at the gingival level(between cusp tips of the right and left primary or permanent canines) 2. Inter molar maxillary arch Width at the gingival level(between mesio- buccul cusp tips of right and left first molars) 3. Maxillary arch depth( from the median point between central incisors to the tangent line between the distal surfaces of the second primary molars or mesial surfaces of first permanent molar.
Measured: Participants will be examined for once "day1"
Secondary outcomes (1)
Percentage occurrence of dental abnormalities.
Percentage occurrence of hypodontia and other dental abnormalities.
Measured: Participants will be examined for once " day 1"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study startMar 2022 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft Lip and PalateStudies 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
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadir ahmed ali hassan, Cairo University
- Investigators
- Hadir A Ali, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791813
- Sponsor's protocol ID
- H92
- Status last verified
- Feb 2022
- First submitted
- 5 Mar 2021
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Subject age, gender, maxillary arch dimensions, and dental anomalies found.
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Maxillary Arch Depth and Width in a Group of Surgically Repaired Unilateral Cleft Lip and Palate Egyptian Children Versus Normal Children .A Cross Sectional Study
- ClinicalTrials.gov ID
- NCT04791813
- Acronym / sponsor ID
- H92
- Conditions
- Cleft Lip and Palate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 10 Mar 2021 (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 the present study is to determine the effect of surgically repaired UCLP on dental arch dimensions and the need for orthodontic intervention in comparison with other healthy children , the presence of dental anomalies and the best possible standards of care among this group of Egyptian children.
Detailed description
In arranging to distinguish and implement the best possible standards of care for UCLP children by the pediatric dental practitioner, evaluation of early treatment results after essential surgical repair of cleft lip and palate with respect to arch dimensions is fundamental. Although the dental arch dimensions for these children have been evaluated in previous studies , few examiners in Egypt handled this issue Due to racial contrasts in improvement of the dental arch and growth .The deficiency of data in Egypt tending to this insufficient assemble of children presents a gap that prevents the transport of fitting dental care to them. This is considered objective to fulfill this gap by spotting the most characteristics of dental arch dimensions in surgically repaired UCLP children and compares them with those of sound, coordinating, non-cleft.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposure group | – | Other: Alginate impressions , Photographic data and panoramic radiographs .group of surgically treated unilateral cleft lip and palate Egyptian children aged 9_12years |
| Control group | – | Other: Alginate impressions , Photographic data and panoramic radiographs .group of healthy Egyptian children aged 9_12years |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy Egyptian children aging from 9-12 years old
Key inclusion criteria (4 listed)
- Cooperative Egyptian children aging from ( 9-12) years.
- Medically free children.
- Children whose families accepts to participate in this study.
- Children with surgically repaired UCLP .
Key exclusion criteria (6 listed)
- Children with previous untreated dental trauma.
- Children with previous orthodontic treatment
- Children with upper respiratory disease
- Children having any systemic diseases
- Intellectual disabilities or syndromes
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 |
|---|---|---|
| Alginate impressions , Photographic data and panoramic radiographs .Upper and lower alginate impressions will be poured and dental casts produced and converted to 3D digital cast using a 3D scanner-(3Shape )-the 3D data will be imported to a revers modeling software . Also Photographic data using Canon750 camera and panoramic radiographs to be taken. | Other | Control group, Exposure group |
Primary outcome
Inter canine maxillary arch width at the gingival level and 2. Inter molar maxillary arch Width at gingival level 3. Maxillary arch depth
Time frame: Participants will be examined for once "day1"
Inter canine maxillary arch width at the gingival level(between cusp tips of the right and left primary or permanent canines) 2. Inter molar maxillary arch Width at the gingival level(between mesio- buccul cusp tips of right and left first molars) 3. Maxillary arch depth( from the median point between central incisors to the tangent line between the distal surfaces of the second primary molars or mesial surfaces of first permanent molar.
1 secondary outcome
Percentage occurrence of dental abnormalities.
Time frame: Participants will be examined for once " day 1"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Individual participant dataSharing planned: Undecided. Subject age, gender, maxillary arch dimensions, and dental anomalies found.
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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.
Hadir A Ali principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
An observational study of Cleft Lip and Palate, 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 6 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 10 Mar 2022. 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 Hadir A Ali, B.D.S (1127370868 ext. 0020, Dr.hadeer.sarhan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter canine maxillary arch width at the gingival level and 2. Inter molar maxillary arch Width at gingival level 3. Maxillary arch depth (time frame: Participants will be examined for once "day1"). 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 10 Mar 2022.