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NCT Number: NCT06602518

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

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.

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Key information

Conditions

Class II Division 2 Malocclusion Malocclusion Malocclusion, Angle Class II Stomatognathic Diseases Tooth Diseases

Age range

12 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Location status: Recruiting

Location contact

Farah Y Eid, PhD

CONTACT

[email protected]

+20 10 01495565

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Orthodontic treatment

Procedure

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.

Primary outcomes

  1. Changes in the sagittal pharyngeal airway space (SPAD)

    Time frame: 6 months

Secondary outcomes

  1. Changes in the mandibular position

    Time frame: 6 months

  2. Sagittal skeletal measurements

    Time frame: 6 months

  3. Vertical skeletal measurements

    Time frame: 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Farah Y Eid, PhD

CONTACT

[email protected]

+201001495565

Sponsors and collaborators

Lead sponsor

Nourhan M.Aly

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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