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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-16
SponsorNourhan M.Aly

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Orthodontic Treatment

    Procedure/Surgery

    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.

Treatment groups

27 Participants
are divided into 1 treatment group
Group A: Levelling and alignmentExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nourhan M.Aly

Lead sponsor

University of Alexandria

Sponsor institution