Sliding jigs versus retraction hooks to move the upper teeth back using IZC miniscrews
A Comparative Evaluation of Whole Maxillary Dentition Distalization Using Sliding Jig vs. Retraction Hooks Anchored by IZC Miniscrews: A Randomized Clinical Trial
We will test whether using a sliding jig or retraction hooks with infrazygomatic-crest (IZC) miniscrews moves the upper teeth back faster, straighter, and more comfortably in people with Class II malocclusion.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | Sana'a University Academic / other |
| Locations | 1 site (Sanaa) |
| Trial ID | NCT07307209 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial will assign eligible patients to maxillary whole-arch distalization using IZC miniscrews with either a sliding jig or retraction hooks. The primary outcome is the rate of first molar distalization in mm/month, while secondary outcomes include tooth movement type (tipping versus translation), 3D miniscrew positional changes, patient comfort, and treatment-related side effects. Clinical measurements, dental casts, and imaging will be collected throughout the active distalization phase to compare efficiency and biomechanical differences. Because interventions are visible, objective imaging and standardized measurement protocols will be used to minimize bias.
Who should consider this trial
Good fit: Patients older than 14 years with bilateral skeletal Class II molar relationship, all permanent teeth present, moderate maxillary crowding (<5 mm) with maxillary protrusion, and no craniofacial syndrome or periodontal disease are ideal candidates.
Not a fit: Patients indicated for extraction treatment, those with transverse or vertical skeletal discrepancies, periodontal disease, unilateral distalization needs, or prior orthodontic treatment are unlikely to benefit from these protocols.
Why it matters
Potential benefit: If successful, the findings could help clinicians choose a technique that achieves faster, more controlled non-extraction correction of Class II malocclusion with fewer side effects and better patient comfort.
How similar studies have performed: TAD-supported maxillary distalization is well described in case series and nonrandomized reports, but no randomized trial has directly compared sliding jigs versus retraction hooks.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The inclusion criteria will be the following: Adult patients with class II malocclusion (\>14 years), present of all permanent teeth fully erupted, Bilateral Class II molar relationship skeletal malocclusion, moderate maxillary arch crowding (less than 5 mm) with maxillary protrusion, absence of craniofacial syndrome. and, except third molars Exclusion Criteria: * The subjects having the following conditions will be excluded from the study (1) Patients with transverse dental or skeletal discrepancies. (2) Patients indicated for extraction treatment (except for third molars) or unilateral distalisation treatment (3) Patients with Vertical growth pattern, (4) Patients having periodontal disease, (5) Patients with previous orthodontic treatment.
Where this trial is running
Sanaa
- Orthodontic department-faculty of dentistry- Sana'a univeristy — Sanaa, Yemen (Recruiting)
Study contacts
- Principal investigator: Nagi H Alawdi, MSc. — Faculty of Dentistry, Sana'a University
- Study coordinator: Nagi H Alawdi, MSc
- Email: nagialawdi@hotmail.com
- Phone: 0770499797
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.