- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05001178
Maturation Within Different Skeletal Growth Patterns Using Maturation Index in Males.
August 4, 2021 updated by: Ahmed Yehia Abdelghaffar Moustafa Saeda, Cairo University
Skeletal Maturation Within Different Skeletal Growth Patterns Using Cervical Vertebrae Maturation Index in Males.
The purpose of the study is to evaluate the difference between the maturation stages between different skeletal growth patterns
Study Overview
Status
Enrolling by invitation
Conditions
Detailed Description
comparing the maturation of different vertical and horizontal growth patterns using CVMI
Study Type
Observational
Enrollment (Anticipated)
180
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Cairo, Egypt
- Faculty of Dentistry - Cairo University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
males patients from 8 - 16 years
Description
Inclusion Criteria:
- Only male patients between 8-16 years old with clear sharp cephalometric radiograph, the radiographs which have all the cervical vertebrae will be included in this study.
Exclusion Criteria:
Previous orthodontic treatment.
- Radiographs of poor quality.
- Any hereditary diseases or syndromes such as Down's syndrome or cleidocranial dysostosis.
- Any disease, trauma or fracture of the jaw that might have affected the normal growth of permanent dentition.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
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Class I horizontal grower
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Class I normal grower
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Class I vertical grower
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Class II horizontal grower
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Class II normal grower
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Class II vertical grower
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Class III horizontal grower
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Class III normal grower
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Class III vertical grower
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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To evaluate the difference between the maturation stages (measured by CVMI index on lateral cephalograms) between different skeletal growth patterns
Time Frame: 8-16 years
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To evaluate the difference between the maturation stages (measured by CVMI index on lateral cephalograms) between different skeletal growth patterns
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8-16 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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to detect whether there were differences in the onsets of the pre-pubertal, pubertal and post-pubertal stages between the various antero-posterior and vertical skeletal patterns
Time Frame: 8-16 years
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to detect whether there were differences in the onsets of the pre-pubertal, pubertal and post-pubertal stages between the various antero-posterior and vertical skeletal patterns
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8-16 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Amr Eldakrory, Professor, Cairo University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Buschang PH, Tanguay R, Demirjian A, LaPalme L, Turkewicz J. Mathematical models of longitudinal mandibular growth for children with normal and untreated Class II, division 1 malocclusion. Eur J Orthod. 1988 Aug;10(3):227-34. doi: 10.1093/ejo/10.3.227. No abstract available.
- Mellion ZJ, Behrents RG, Johnston LE Jr. The pattern of facial skeletal growth and its relationship to various common indexes of maturation. Am J Orthod Dentofacial Orthop. 2013 Jun;143(6):845-54. doi: 10.1016/j.ajodo.2013.01.019.
- Marceau K, Ram N, Houts RM, Grimm KJ, Susman EJ. Individual differences in boys' and girls' timing and tempo of puberty: modeling development with nonlinear growth models. Dev Psychol. 2011 Sep;47(5):1389-1409. doi: 10.1037/a0023838.
- Cole TJ, Rousham EK, Hawley NL, Cameron N, Norris SA, Pettifor JM. Ethnic and sex differences in skeletal maturation among the Birth to Twenty cohort in South Africa. Arch Dis Child. 2015 Feb;100(2):138-43. doi: 10.1136/archdischild-2014-306399. Epub 2014 Nov 19.
- Soegiharto BM, Moles DR, Cunningham SJ. Discriminatory ability of the skeletal maturation index and the cervical vertebrae maturation index in detecting peak pubertal growth in Indonesian and white subjects with receiver operating characteristics analysis. Am J Orthod Dentofacial Orthop. 2008 Aug;134(2):227-37. doi: 10.1016/j.ajodo.2006.09.062.
- Kim JH, Viana MA, Graber TM, Omerza FF, BeGole EA. The effectiveness of protraction face mask therapy: a meta-analysis. Am J Orthod Dentofacial Orthop. 1999 Jun;115(6):675-85. doi: 10.1016/s0889-5406(99)70294-5.
- Nanda SK. Patterns of vertical growth in the face. Am J Orthod Dentofacial Orthop. 1988 Feb;93(2):103-16. doi: 10.1016/0889-5406(88)90287-9.
- Kuc-Michalska M, Baccetti T. Duration of the pubertal peak in skeletal Class I and Class III subjects. Angle Orthod. 2010 Jan;80(1):54-7. doi: 10.2319/020309-69.1.
- Jeelani W, Fida M, Shaikh A. The duration of pubertal growth peak among three skeletal classes. Dental Press J Orthod. 2016 Sep-Oct;21(5):67-74. doi: 10.1590/2177-6709.21.5.067-074.oar.
- Baccetti T, Franchi L, McNamara JA Jr. An improved version of the cervical vertebral maturation (CVM) method for the assessment of mandibular growth. Angle Orthod. 2002 Aug;72(4):316-23. doi: 10.1043/0003-3219(2002)0722.0.CO;2.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
August 1, 2021
Primary Completion (Anticipated)
October 1, 2021
Study Completion (Anticipated)
November 1, 2021
Study Registration Dates
First Submitted
August 4, 2021
First Submitted That Met QC Criteria
August 4, 2021
First Posted (Actual)
August 11, 2021
Study Record Updates
Last Update Posted (Actual)
August 11, 2021
Last Update Submitted That Met QC Criteria
August 4, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 12-5-21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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