Investigating Genetic Biomarkers in the Early Detection of Skeletal Class III Malocclusion: An Observational Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 93
- Locations
- 1
- Primary Endpoint
- presence of single nucleotide polymorphism
Study Overview
Brief Summary
Purpose of the Research:
To reveal the genetic cause for the occurrence of Class III malocclusion, or what may be described as a reverse bite (underbite).
Introduction and Detailed Procedures for the Patient (Work Plan):
- The volunteer will rinse their mouth with chlorhexidine before taking the swab.
- A saliva sample will be collected from the patient using a syringe, along with a frontal facial photograph and a lateral cephalometric X-ray.
- DNA / genetic material will be extracted from the sample.
- Screening will be conducted for genetic mutations that may be responsible for the occurrence of the underbite.
- The photographs and X-rays will be analyzed and compared with the swab results.
- This data will be analyzed to determine whether the detected mutations are the cause of the underbite.
- The sample will be retained for use in future research studies.
Side Effects, Expected Risk Levels, and Management"
- Pain: Mild discomfort during swab collection, which does not require any painkillers.
- Infection/Inflammation: Mild inflammation at the sample site or a secondary bacterial infection; in this case, antibiotics may be prescribed if necessary.
- Risk Level: Low risk, estimated to be less than 5%.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 10 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •for Control group:
- •Patients of Egyptian nationality.
- •ANB from 0° to 4.8°.ANB from 0° to 4.8°.
- •Wits appraisal no less than -3.0 mm.
- •Inclusion Criteria for Study group:
- •Patients of Egyptian nationality.
- •ANB (angle between point A, nasion and point B at nasion) angle (point A-nasion point B) of less than 0 degrees.
- •Negative Wits appraisal greater than -3.0 mm.
Exclusion Criteria
- •The presence of any growth disturbances, syndromes, congenital abnormalities, & endocrine disorders.
- •Patients subjected to previous orthodontic, orthopedic, or orthognathic treatment.
- •Poor quality of radiographic records.
- •Consent form not signed.
Arms & Interventions
Study Group
skeletal class III, Negative Wits appraisal greater than -3.0 mm, ANB < 0°
Control Group
skeletal class I, Wits appraisal no less than -3.0 mm, ANB from 0° to 4.8°.
Outcomes
Primary Outcomes
presence of single nucleotide polymorphism
Time Frame: cross-sectional - results are assessed at one point of time (Preintervention)
difference in snps between control and study group
Secondary Outcomes
- lateral cephalometric measurements(cross-sectional - results are assessed at one point of time (Preintervention))
- Frontal photos measurements(cross-sectional - results are assessed at one point of time (Preintervention))
Investigators
Beshoy Magdy Kamel Moharib
Master's student candidate in orthodontics department
Cairo University
