Cleft Lip and PalateNCT05031039
Skeletal and Dental Maturational Stages in a Sample of Egyptian Subjects With Cleft Lip and Palate Deformity
An observational study of Cleft Lip and Palate, run by Cairo University.
Trial summary
The aim of this research is to evaluate the skeletal and dental maturation of cleft lip and palate patients in a sample of Egyptian population using the CVM as indicator for the skeletal maturation and the Demirjian method as indicator for the dental one when compared to a group of Egyptian non-CLP subjects of the… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cleft Lip and Palate
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Sep 2021to 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 6 to 18 years
- All sexes
- Child, Adult
Study population: Egyptian subjects with Cleft Lip and Palate Deformity
Who may be able to join
- Subjects with non-syndromic CLP aged 6-18 years. (2) Subjects with no CLP deformity, aged 6-18 years. (4) Patients having complete records comprising dental/medical history and a lateral cephalometric and panoramic radiograph.
- No congenitally missing teeth in the mandible. (6) No previous history of trauma to the face, neck.
Who cannot join
- Radiographs of poor quality.
- Any growth or hereditary or systematic diseases or syndromes
- Any trauma or fracture of the jaw that might have affected the normal growth of permanent dentition.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Skeletal and Dental Maturational Stages in a Sample of Egyptian Subjects With Cleft Lip and Palate Deformity: A Cross-Sectional Study
The aim of this research is to evaluate the skeletal and dental maturation of cleft lip and palate patients in a sample of Egyptian population using the CVM as indicator for the skeletal maturation and the Demirjian method as indicator for the dental one when compared to a group of Egyptian non-CLP subjects of the same age.
Read the detailed description
Chronological age (CA) is not considered an accurate method for assessing the stage of physical or growth development of an individual in childhood or adolescence. For that reason, skeletal and dental maturation can be used in order to examine the rate of physical maturation of the population. Cervical vertebral maturation (CVM) method uses lateral cephalometric radiography to evaluate skeletal maturity. It is considered the preferable method due to its advantage of avoiding unnecessary extra radiation. The CVM method developed by Baccetti et al. (2005) depends on the morphology of the three cervical vertebrae (C2, C3, and C4), which divided skeletal growth into six stages of based on the morphology of the previously mentioned cervical vertebrae. The Demirjian method is considered as one of the most worldwide used method for assessment of the dental maturation due to its reliability. It depends on panoramic x-rays through which the dental developmental stage of 7 lower left teeth appears, and according to the gender of the patient the sum of values of the teeth will be transform to age through the standard tables of Carmen M. Nolla; 1960.
- Conditions
- Cleft Lip and Palate
- Keywords
- skeletal & dental maturational stages
- Medical subject headings
- Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Female Egyptian subjects with Cleft Lip and Palate Deformity | Egyptians females that have unilateral or bilateral cleft lip and palate deformity | |
| Male Egyptian subjects with Cleft Lip and Palate Deformity | Egyptians males that have unilateral or bilateral cleft lip and palate deformity |
What is being measured
The primary outcome is the main question the study is designed to answer.
dental age
Dental age will be evaluated by the Demirjian method
Measured: 5 months
Secondary outcomes (1)
skeletal age
skeletal age will be measured using the cervical vertebral method that was modified by Baccetti 2005
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study startSep 2021 (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 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
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, omima khaled salah, orthodontist, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031039
- Sponsor's protocol ID
- 14422018441165
- Status last verified
- Aug 2021
- First submitted
- 20 Aug 2021
- Last updated
- 1 Sep 2021
- 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 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skeletal and Dental Maturational Stages in a Sample of Egyptian Subjects With Cleft Lip and Palate Deformity: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT05031039
- Acronym / sponsor ID
- 14422018441165
- Conditions
- Cleft Lip and Palate
- Keywords
- skeletal & dental maturational stages
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 1 Sep 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 this research is to evaluate the skeletal and dental maturation of cleft lip and palate patients in a sample of Egyptian population using the CVM as indicator for the skeletal maturation and the Demirjian method as indicator for the dental one when compared to a group of Egyptian non-CLP subjects of the same age.
Detailed description
Chronological age (CA) is not considered an accurate method for assessing the stage of physical or growth development of an individual in childhood or adolescence. For that reason, skeletal and dental maturation can be used in order to examine the rate of physical maturation of the population. Cervical vertebral maturation (CVM) method uses lateral cephalometric radiography to evaluate skeletal maturity. It is considered the preferable method due to its advantage of avoiding unnecessary extra radiation. The CVM method developed by Baccetti et al. (2005) depends on the morphology of the three cervical vertebrae (C2, C3, and C4), which divided skeletal growth into six stages of based on the morphology of the previously mentioned cervical vertebrae. The Demirjian method is considered as one of the most worldwide used method for assessment of the dental maturation due to its reliability. It depends on panoramic x-rays through which the dental developmental stage of 7 lower left teeth appears, and according to the gender of the patient the sum of values of the teeth will be transform to age through the standard tables of Carmen M. Nolla; 1960.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Female Egyptian subjects with Cleft Lip and Palate Deformity | – | –Egyptians females that have unilateral or bilateral cleft lip and palate deformity |
| Male Egyptian subjects with Cleft Lip and Palate Deformity | – | –Egyptians males that have unilateral or bilateral cleft lip and palate deformity |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Egyptian subjects with Cleft Lip and Palate Deformity
Key inclusion criteria (2 listed)
- Subjects with non-syndromic CLP aged 6-18 years. (2) Subjects with no CLP deformity, aged 6-18 years. (4) Patients having complete records comprising dental/medical history and a lateral cephalometric and panoramic radiograph.
- No congenitally missing teeth in the mandible. (6) No previous history of trauma to the face, neck.
Key exclusion criteria (3 listed)
- Radiographs of poor quality.
- Any growth or hereditary or systematic diseases or syndromes
- Any trauma or fracture of the jaw that might have affected the normal growth of permanent dentition.
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
dental age
Time frame: 5 months
Dental age will be evaluated by the Demirjian method
1 secondary outcome
skeletal age
Time frame: 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
Related trials for Cleft Lip and Palate
Not yet recruiting
Comparative Study of Regional Nerve Blocks in Primary Cleft Palate Repair
Cleft Lip, Cleft Palate +/- Lip
Not yet recruiting
Quadratus Lumborum Block for Iliac Bone Harvest in Pediatric Cleft Alveolus Repair
Cleft Lip Palate
RecruitingObservational study
Perceptions of High and Low Intensity Speech Intervention in Children With a Cleft Palate
Cleft Lip and Palate, Cleft Palate Children
Not yet recruitingPhase 3
Safety and Efficacy of Bone Bioengineering Kit With Stem Cells for Alveolar Cleft Repair
Cleft Lip Palate
Enrolling by invitation
Speech Intervention Frameworks in Cantonese-speaking Children and Adolescences With Cleft Palate +/- Lip
Cleft Palate +/- Lip
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.
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 2 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: status not confirmed, as of the sponsor's last update on 1 Sep 2021. 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 omima khaled salah, B.D.S 2014 (01097494295 ext. 01005461079, omima.salah@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dental age (time frame: 5 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 1 Sep 2021.