- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03085082
Study of the Relationship Between Blood Groups,RH and Skeletal Malocclusion : a Cross Sectional Study
March 20, 2017 updated by: Noor Elsebai Mohamed, Cairo University
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
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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A blood sample will be withdrawn and taken to the Cairo university laboratory to analyze the blood group and RH .a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 Type
Observational
Enrollment (Anticipated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
all patients with skeletal malovclusion seeking medical care in the orthodontic department of cairo university for six months
Description
Inclusion Criteria:
skeletal class I,II and III patients non syndromic patients above the age of 18 no previous surgical intervention for correction of skeletal malocclusion
Exclusion Criteria:
- syndromic patients
- cleft patients
- patients with previous surgery to correct skeletal malocclusion
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: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
skeletal class II subjects
patients with wits appraisal more than 3 mm measured on a cephalometric x ray obtained during diagnosis
|
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
Other Names:
|
|
skeletal class III subjects
patients with wits appraisal less than -3 mm measured on a cephalometric x ray obtained during diagnosis
|
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
Other Names:
|
|
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
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
the recruitment will be for six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Amgad qaddah, professor, head of department of orthodontics 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
- 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.
- Science, D. (2015). International Journal of Pharma and Bio Sciences ISSN CRANIOFACIAL MORPHOLOGY WITH GENETIC INFLUENCE OF ABO BLOOD, 6(4), 412±418.
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)
April 1, 2017
Primary Completion (Anticipated)
September 1, 2017
Study Completion (Anticipated)
December 31, 2017
Study Registration Dates
First Submitted
March 15, 2017
First Submitted That Met QC Criteria
March 15, 2017
First Posted (Actual)
March 21, 2017
Study Record Updates
Last Update Posted (Actual)
March 22, 2017
Last Update Submitted That Met QC Criteria
March 20, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Congenital Abnormalities
- Musculoskeletal Diseases
- Stomatognathic Diseases
- Tooth Diseases
- Stomatognathic System Abnormalities
- Jaw Abnormalities
- Jaw Diseases
- Maxillofacial Abnormalities
- Craniofacial Abnormalities
- Musculoskeletal Abnormalities
- Mandibular Diseases
- Malocclusion
- Malocclusion, Angle Class II
- Overbite
- Prognathism
- Malocclusion, Angle Class III
Other Study ID Numbers
- skeletal_malocclusion_ABO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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