"Sliding Jigs vs Retraction Hooks for Maxillary Dentition Distalization Using IZC Miniscrews"

ConditionSkeletal Class II Malocclusion

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age14+

SponsorSana'a University

About this trial

This randomized controlled clinical trial aims to compare the clinical efficacy, efficiency, and biomechanical differences between two methods for total maxillary dentition distalization: (1) the use of a Sliding Jig and (2) the use of Retraction Hooks, both anchored by Infrazygomatic Crest (IZC) miniscrews. The study will assess rates of distalization, anchorage loss, dentoalveolar tipping, patient comfort, and treatment-associated side effects.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Sliding jig
Device
participants in this group will undergo whole maxillary dentition distalization using Sliding Jig mechanics anchored by infrazygomatic crest (IZC) miniscrews.
retraction hooks
Device
participants in this group will undergo whole maxillary dentition distalization using Retraction Hooks mechanics anchored by infrazygomatic crest (IZC) miniscrews.

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Sliding JigExperimental treatment 1 intervention

Group B: Retraction HookActive comparator 1 intervention

Trial outcomes

Primary outcomes

Rate of Molar Distalization.

Measured on digital models (from intraoral scans) by comparing the 3D position of the maxillary first molar (mesial contact point) relative to the stable palatal rugae at T0 (pre-distalization) and T1 (after 4mm distalization achieved or 6 months).

Time frame

From baseline (start of distalization) to the completion of distalization (an average of 5 months).

Rate of maxillary first molar distalization

The linear distal movement of the maxillary first molar, measured via 3D superimposition of serial digital intraoral scans on the stable palatal rugae, divided by the active treatment time in months to yield a rate in mm/month.

Time frame

From baseline (start of active distalization forces) to the completion of planned distalization (target: 4-6 mm) or at 6 months, whichever comes first.*

Sponsors and contacts

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Sana'a University

Lead sponsor

Source ClinicalTrials.gov

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