Class II MalocclusionNCT03085082
Study of the Relationship Between Blood Groups,RH and Skeletal Malocclusion : a Cross Sectional Study
An observational study of Class II Malocclusion and Class III Malocclusion, run by Cairo University.
Trial summary
the study is searching if there is a relationship between the blood groups and RH and the skeletal malocclusion using the skeletal class I as a control group Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Class II Malocclusion, Class III Malocclusion
- What is being tested?
- blood type test
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2017to 31 Dec 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: all patients with skeletal malovclusion seeking medical care in the orthodontic department of cairo university for six months
Who may be able to join
- skeletal class I,II and III patients non syndromic patients above the age of 18 no previous surgical intervention for correction of skeletal malocclusion
Who cannot join
- syndromic patients
- cleft patients
- patients with previous surgery to correct skeletal malocclusion
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Study of the Relationship Between Blood Groups,RH and Skeletal Malocclusion in a Group of Egyptian Population: a Cross Sectional Study
the study is searching if there is a relationship between the blood groups and RH and the skeletal malocclusion using the skeletal class I as a control group
Read the detailed description
The study will be conducted on the patients seeking medical care in the orthodontic department Cairo University, for six months all patients with class II and class III malocclusion will be recruited based on Wits appraisal measured from the cephalometric X-ray taken routinely during orthodontic examination. Then a group of class I arch length discrepancy patients will be used as control. A blood sample will be withdrawn and taken to the Cairo university laboratory to analyze the blood group and RH .a statistical analysis will be performed to detect a relationship between skeletal malocclusion and the blood groups as compared to the control
- Conditions
- Class II Malocclusion, Class III Malocclusion
- Being tested
- blood type test
- Medical subject headings
- Overbite, Malocclusion, Angle Class III
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood type testDiagnostic test
Also called ABO and RH test, blood typing
a blood sample will be withdrawn from the subjects tested by anti A anti B and anti D antigens to detect the individuals blood group and RH. then statistical analysis to detect presence of a relationship between skeletal types of malocclusion and ABO blood groups
| Study group | Role | What they receive |
|---|---|---|
| skeletal class II subjects | patients with wits appraisal more than 3 mm measured on a cephalometric x ray obtained during diagnosis Receives: Diagnostic Test: blood type test | |
| skeletal class III subjects | patients with wits appraisal less than -3 mm measured on a cephalometric x ray obtained during diagnosis Receives: Diagnostic Test: blood type test | |
| skeletal class I patients | patients with Wits appraisal between -3 and +3 that is measured from a cephalometric x ray obtained during diagnosis of arch length discrepancy. this group will serve as control and obtained after recruitment of the other 2 groups in 1 to 1 fashion Receives: Diagnostic Test: blood type test |
What is being measured
The primary outcome is the main question the study is designed to answer.
relationship between blood group and skeletal malocclusion
If skeletal malocclusion subjects were found to have a high percentage of a certain blood type or RH when compared to the control group it will be reported that there is a relationship between blood group and skeletal malocclusion. If percentages of blood groups are approximately the same in the malocclusion subjects and the control then the investigator will report that there is no relationship between blood groups and skeletal malocclusion
Measured: the recruitment will be for six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start1 Apr 2017 (estimated)
- Primary completion1 Sep 2017 (estimated)
- Study completion31 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Class II MalocclusionStudies 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
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noor Elsebai Mohamed, Cairo University
- Investigators
- Amgad qaddah, professor, Study director, head of department of orthodontics cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03085082
- Sponsor's protocol ID
- skeletal_malocclusion_ABO
- Status last verified
- Mar 2017
- First submitted
- 15 Mar 2017
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Flannery, P. M. (1969). Loyola eCommons The Abo Human Blood Groups and Skeletal Class IIi Malocclusions.
Schnibben, C. L. (1968). Loyola eCommons A Study of the Relationships of the ABO Human Blood Groups , the Rh Factor and Hereditary Malocclusions of the Skeletal Type , Class II , Division 1.
Gheisari R, Ghoreishian M, Movahedian B, Roozbehi A. The association between blood groups and maxillofacial deformities. Indian J Plast Surg. 2008 Jul;41(2):138-40. doi: 10.4103/0970-0358.44921.
PubMed 19753252Science, D. (2015). International Journal of Pharma and Bio Sciences ISSN CRANIOFACIAL MORPHOLOGY WITH GENETIC INFLUENCE OF ABO BLOOD, 6(4), 412±418.
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Relationship Between Blood Groups,RH and Skeletal Malocclusion in a Group of Egyptian Population: a Cross Sectional Study
- ClinicalTrials.gov ID
- NCT03085082
- Acronym / sponsor ID
- skeletal_malocclusion_ABO
- Conditions
- Class II Malocclusion, Class III Malocclusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2017 (estimated)
- Primary completion
- 1 Sep 2017 (estimated)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 21 Mar 2017 (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 study is searching if there is a relationship between the blood groups and RH and the skeletal malocclusion using the skeletal class I as a control group
Detailed description
The study will be conducted on the patients seeking medical care in the orthodontic department Cairo University, for six months all patients with class II and class III malocclusion will be recruited based on Wits appraisal measured from the cephalometric X-ray taken routinely during orthodontic examination. Then a group of class I arch length discrepancy patients will be used as control. A blood sample will be withdrawn and taken to the Cairo university laboratory to analyze the blood group and RH .a statistical analysis will be performed to detect a relationship between skeletal malocclusion and the blood groups as compared to the control
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| skeletal class II subjects | – | Diagnostic Test: blood type testpatients with wits appraisal more than 3 mm measured on a cephalometric x ray obtained during diagnosis |
| skeletal class III subjects | – | Diagnostic Test: blood type testpatients with wits appraisal less than -3 mm measured on a cephalometric x ray obtained during diagnosis |
| skeletal class I patients | – | Diagnostic Test: blood type testpatients with Wits appraisal between -3 and +3 that is measured from a cephalometric x ray obtained during diagnosis of arch length discrepancy. this group will serve as control and obtained after recruitment of the other 2 groups in 1 to 1 fashion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- all patients with skeletal malovclusion seeking medical care in the orthodontic department of cairo university for six months
Key inclusion criteria (1 listed)
- skeletal class I,II and III patients non syndromic patients above the age of 18 no previous surgical intervention for correction of skeletal malocclusion
Key exclusion criteria (3 listed)
- syndromic patients
- cleft patients
- patients with previous surgery to correct skeletal malocclusion
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 |
|---|---|---|
| blood type testAlso: ABO and RH test, blood typinga blood sample will be withdrawn from the subjects tested by anti A anti B and anti D antigens to detect the individuals blood group and RH. then statistical analysis to detect presence of a relationship between skeletal types of malocclusion and ABO blood groups | Diagnostic test | skeletal class I patients, skeletal class II subjects, skeletal class III subjects |
Primary outcome
relationship between blood group and skeletal malocclusion
Time frame: the recruitment will be for six months
If skeletal malocclusion subjects were found to have a high percentage of a certain blood type or RH when compared to the control group it will be reported that there is a relationship between blood group and skeletal malocclusion. If percentages of blood groups are approximately the same in the malocclusion subjects and the control then the investigator will report that there is no relationship between blood groups and skeletal malocclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
- BackgroundFlannery, P. M. (1969). Loyola eCommons The Abo Human Blood Groups and Skeletal Class IIi Malocclusions.
- BackgroundSchnibben, C. L. (1968). Loyola eCommons A Study of the Relationships of the ABO Human Blood Groups , the Rh Factor and Hereditary Malocclusions of the Skeletal Type , Class II , Division 1.
- Background: PubMed 19753252Gheisari R, Ghoreishian M, Movahedian B, Roozbehi A. The association between blood groups and maxillofacial deformities. Indian J Plast Surg. 2008 Jul;41(2):138-40. doi: 10.4103/0970-0358.44921.
- BackgroundScience, D. (2015). International Journal of Pharma and Bio Sciences ISSN CRANIOFACIAL MORPHOLOGY WITH GENETIC INFLUENCE OF ABO BLOOD, 6(4), 412±418.
- Individual participant dataSharing planned: No
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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.
Amgad qaddah, professor study director
head of department of orthodontics cairo university
Questions about this trial
What is this clinical trial studying?
An observational study of Class II Malocclusion and Class III Malocclusion, 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 1 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 22 Mar 2017. 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 Noor Elsebai (01023415842, noorelsebai@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relationship between blood group and skeletal malocclusion (time frame: the recruitment will be for six months). 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 NCT03085082, which also lists 4 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 22 Mar 2017.