Changes in the Sagittal Pharyngeal Airway Dimension Following Leveling and Alignement in Class II Division 2 Patients

September 15, 2024 updated by: Nourhan M.Aly

Changes in the Sagittal Pharyngeal Airway Dimension Following Leveling and Alignement in Class II Division 2 Patients: A Prospective Clinical Trial

Aim of the study: is to compare the changes in the sagittal pharyngeal airway dimension (SPAD) and mandibular position before and after the levelling and alignment stage of orthodontic treatment in Class II division 2 patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Recruiting
        • Faculty of Dentistry, Alexandria University
        • Contact:

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

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Class II/2 subjects as per the British Standard Institute Classification.
  • Age ranging from 12-16 years, with Cervical Vertebral Maturational Index (CVMI) stages 4, and 5.
  • Contact between maxillary and mandibular incisors, with the presence of a deep bite of at least 70%.
  • Full permanent dentition, aside from the third molars

Exclusion Criteria:

  • Previous orthodontic treatment.
  • Patients with severe transverse problems, pain and/or clicking sound in the temporomandibular joint (TMJ).
  • Patients with craniofacial anomalies or diagnosed syndromes

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Levelling and alignment
Procedure: Orthodontic Treatment
All the enrolled patients will undergo conventional fixed appliance therapy by bonding straight wire Roth appliance in the maxillary arch. The bonding procedure will be standardized in all patients and performed by the same operator using light-cured composite. Levelling and alignment will then be started using the following wire sequence: 0.014-in nickel titanium (NiTi), 0.018-in NiTi, 17×25-in Niti, and 19×25-in Niti arch wires. The upper arch will then be stabilized using a 19×25-in stainless steel (SS) arch wire for 2 months. This stage will require approximately 6 months of treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in the sagittal pharyngeal airway space (SPAD)
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in the mandibular position
Time Frame: 6 months
6 months
Sagittal skeletal measurements
Time Frame: 6 months
6 months
Vertical skeletal measurements
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nourhan M.Aly

Investigators

  • Principal Investigator: Farah Y Eid, PhD, Faculty of Dentistry, Alexandria University, Egypt
  • Study Director: Dina Elfouly, PhD, Faculty of Dentistry, Alexandria University, Egypt
  • Study Chair: Ahmed Madian, PhD, Faculty of Dentistry, Alexandria University, Egypt

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 (Actual)

June 20, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

September 15, 2024

First Submitted That Met QC Criteria

September 15, 2024

First Posted (Estimated)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 15, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1/6-2024

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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