Class II Division 2 MalocclusionNCT06602518
Changes in the Sagittal Pharyngeal Airway Dimension Following Leveling and Alignement in Class II Division 2 Patients
A study testing Orthodontic Treatment in people with Class II Division 2 Malocclusion, run by Nourhan M.Aly at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 16 years
- Conditions the study is for
- Class II Division 2 Malocclusion
- What is being tested?
- Orthodontic Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jun 2024to Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Alexandria University
Alexandria
Farah Y Eid, PhD, +20 10 01495565, farahyousry66@gmail.com
About this study
Official title: 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.
- Conditions
- Class II Division 2 Malocclusion
- Being tested
- Orthodontic Treatment
- Medical subject headings
- Malocclusion, Angle Class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthodontic TreatmentProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Levelling and alignment | Experimental | Not described Receives: Procedure: Orthodontic Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the sagittal pharyngeal airway space (SPAD)
Measured: 6 months
Secondary outcomes (3)
Changes in the mandibular position
Measured: 6 months
Sagittal skeletal measurements
Measured: 6 months
Vertical skeletal measurements
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start20 Jun 2024
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Class II Division 2 MalocclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nourhan M.Aly
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nourhan M.Aly, University of Alexandria
- Investigators
- Farah Y Eid, PhD, Principal investigator, Faculty of Dentistry, Alexandria University, EgyptDina Elfouly, PhD, Study director, Faculty of Dentistry, Alexandria University, EgyptAhmed Madian, PhD, Study chair, Faculty of Dentistry, Alexandria University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06602518
- Sponsor's protocol ID
- 1/6-2024
- Status last verified
- Sep 2024
- First submitted
- 15 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Eid FY, Madian AM, Elfouly D. Changes in the sagittal pharyngeal airway dimension following levelling and alignment in class II division 2 patients: a prospective clinical trial. Clin Oral Investig. 2026 Jun 5;30(6):279. doi: 10.1007/s00784-026-06944-2.
PubMed 42247179
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in the Sagittal Pharyngeal Airway Dimension Following Leveling and Alignement in Class II Division 2 Patients: A Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT06602518
- Acronym / sponsor ID
- 1/6-2024
- Conditions
- Class II Division 2 Malocclusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Nourhan M.AlyUniversity, hospital or other
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Levelling and alignment | Experimental | Procedure: Orthodontic Treatment |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orthodontic TreatmentAll 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. | Procedure or surgery | Levelling and alignment |
Primary outcome
Changes in the sagittal pharyngeal airway space (SPAD)
Time frame: 6 months
3 secondary outcomes
Changes in the mandibular position
Time frame: 6 months
Sagittal skeletal measurements
Time frame: 6 months
Vertical skeletal measurements
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 42247179Eid FY, Madian AM, Elfouly D. Changes in the sagittal pharyngeal airway dimension following levelling and alignment in class II division 2 patients: a prospective clinical trial. Clin Oral Investig. 2026 Jun 5;30(6):279. doi: 10.1007/s00784-026-06944-2.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Farah Y Eid, PhD principal investigator
Faculty of Dentistry, Alexandria University, Egypt
Dina Elfouly, PhD study director
Faculty of Dentistry, Alexandria University, Egypt
Ahmed Madian, PhD study chair
Faculty of Dentistry, Alexandria University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orthodontic Treatment in people with Class II Division 2 Malocclusion, run by Nourhan M.Aly at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Farah Y Eid, PhD (+201001495565, farahyousry66@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the sagittal pharyngeal airway space (SPAD) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06602518, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.