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Clinical Trials/NCT07749638
NCT07749638CompletedNot Applicable

Investigating Genetic Biomarkers in the Early Detection of Skeletal Class III Malocclusion: An Observational Study

Cairo University1 site in 1 country93 target enrollmentStarted: October 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
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):

  1. The volunteer will rinse their mouth with chlorhexidine before taking the swab.
  2. A saliva sample will be collected from the patient using a syringe, along with a frontal facial photograph and a lateral cephalometric X-ray.
  3. DNA / genetic material will be extracted from the sample.
  4. Screening will be conducted for genetic mutations that may be responsible for the occurrence of the underbite.
  5. The photographs and X-rays will be analyzed and compared with the swab results.
  6. This data will be analyzed to determine whether the detected mutations are the cause of the underbite.
  7. 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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Beshoy Magdy Kamel Moharib

Master's student candidate in orthodontics department

Cairo University

Study Sites (1)

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