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

NCT ID: NCT06602518

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-20

Study Completion Date

2025-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Class II Division 2 Malocclusion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Levelling and alignment

Group Type EXPERIMENTAL

Orthodontic Treatment

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nourhan M.Aly

OTHER

Sponsor Role lead

Responsible Party

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Nourhan M.Aly

Assistant Lecturer of Dental Public Health

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Farah Y Eid, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Alexandria University, Egypt

Dina Elfouly, PhD

Role: STUDY_DIRECTOR

Faculty of Dentistry, Alexandria University, Egypt

Ahmed Madian, PhD

Role: STUDY_CHAIR

Faculty of Dentistry, Alexandria University, Egypt

Locations

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Faculty of Dentistry, Alexandria University

Alexandria, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Farah Y Eid, PhD

Role: CONTACT

+201001495565

Facility Contacts

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Farah Y Eid, PhD

Role: primary

+20 10 01495565

Other Identifiers

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1/6-2024

Identifier Type: -

Identifier Source: org_study_id

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