Skeletal MaturationNCT05001178
Maturation Within Different Skeletal Growth Patterns Using Maturation Index in Males.
An observational study of Skeletal Maturation, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of the study is to evaluate the difference between the maturation stages between different skeletal growth patterns Read more about this study
- Who is it for?
- Ages 8 to 16 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Skeletal Maturation
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2021to Nov 2021
- 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 8 to 16 years
- Men only
- Healthy volunteers accepted
- Child
Study population: males patients from 8 - 16 years
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the detailed description
comparing the maturation of different vertical and horizontal growth patterns using CVMI
- Conditions
- Skeletal Maturation
- Keywords
- cervical vertebrae maturation index
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 |
|---|---|---|
| Class I horizontal grower | Not described | |
| Class I normal grower | Not described | |
| Class I vertical grower | Not described | |
| Class II horizontal grower | Not described | |
| Class II normal grower | Not described | |
| Class II vertical grower | Not described | |
| Class III horizontal grower | Not described | |
| Class III normal grower | Not described | |
| Class III vertical grower | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the difference between the maturation stages (measured by CVMI index on lateral cephalograms) between different skeletal growth patterns
To evaluate the difference between the maturation stages (measured by CVMI index on lateral cephalograms) between different skeletal growth patterns
Measured: 8-16 years
Secondary outcomes (1)
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
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
Measured: 8-16 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study startAug 2021 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Skeletal MaturationStudies 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
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Yehia Abdelghaffar Moustafa Saeda, Cairo University
- Investigators
- Amr Eldakrory, Professor, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05001178
- Sponsor's protocol ID
- 12-5-21
- Status last verified
- Aug 2021
- First submitted
- 4 Aug 2021
- Last updated
- 11 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 23726335Marceau 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.
PubMed 21639623Cole 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.
PubMed 25409981Soegiharto 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.
PubMed 18675204Kim 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.
PubMed 10358251Nanda 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.
PubMed 3422525Kuc-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.
PubMed 19852640Jeelani 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.
PubMed 27901231Baccetti 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.
PubMed 12169031Buschang 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.
PubMed 3181302
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skeletal Maturation Within Different Skeletal Growth Patterns Using Cervical Vertebrae Maturation Index in Males.
- ClinicalTrials.gov ID
- NCT05001178
- Acronym / sponsor ID
- 12-5-21
- Conditions
- Skeletal Maturation
- Keywords
- cervical vertebrae maturation index
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2021 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 11 Aug 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 purpose of the study is to evaluate the difference between the maturation stages between different skeletal growth patterns
Detailed description
comparing the maturation of different vertical and horizontal growth patterns using CVMI
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Class I horizontal grower | – | – |
| Class I normal grower | – | – |
| Class I vertical grower | – | – |
| Class II horizontal grower | – | – |
| Class II normal grower | – | – |
| Class II vertical grower | – | – |
| Class III horizontal grower | – | – |
| Class III normal grower | – | – |
| Class III vertical grower | – | – |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- males patients from 8 - 16 years
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- Previous orthodontic treatment.
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
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
To evaluate the difference between the maturation stages (measured by CVMI index on lateral cephalograms) between different skeletal growth patterns
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
- Background: PubMed 23726335Mellion 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.
- Background: PubMed 21639623Marceau 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.
- Background: PubMed 25409981Cole 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.
- Background: PubMed 18675204Soegiharto 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.
- Background: PubMed 10358251Kim 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.
- Background: PubMed 3422525Nanda 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.
- Background: PubMed 19852640Kuc-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.
- Background: PubMed 27901231Jeelani 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.
- Background: PubMed 12169031Baccetti 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.
- Background: PubMed 3181302Buschang 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.
- Individual participant dataSharing planned: Undecided
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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.
Amr Eldakrory, Professor principal investigator
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 Skeletal Maturation, 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 1 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 11 Aug 2021. 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?
Results are not available in the source record.
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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05001178, which also lists 10 linked publications.
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 11 Aug 2021.