Changes in the Sagittal Pharyngeal Airway Dimension Following Leveling and Alignement in Class II Division 2 Patients
1 other identifier
interventional
27
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 20, 2024
CompletedFirst Submitted
Initial submission to the registry
September 15, 2024
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2025
CompletedSeptember 19, 2024
September 1, 2024
7 months
September 15, 2024
September 15, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in the sagittal pharyngeal airway space (SPAD)
6 months
Secondary Outcomes (3)
Changes in the mandibular position
6 months
Sagittal skeletal measurements
6 months
Vertical skeletal measurements
6 months
Study Arms (1)
Levelling and alignment
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nourhan M.Alylead
Study Sites (1)
Faculty of Dentistry, Alexandria University
Alexandria, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Lecturer of Dental Public Health
Study Record Dates
First Submitted
September 15, 2024
First Posted
September 19, 2024
Study Start
June 20, 2024
Primary Completion
January 1, 2025
Study Completion
January 1, 2025
Last Updated
September 19, 2024
Record last verified: 2024-09