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

NCT07307209 | Recruiting DMC

• 2 other identifiers: SU-ORTHO-IZC-RCT-2025EC-OR: 03\9\ 2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Skeletal Class II Malocclusion

Keywords

Maxillary Distalization; IZC Miniscrew; Sliding Jig

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

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

Study Arms (2)

Sliding Jig

EXPERIMENTAL

Description: Participants in this group will undergo whole maxillary dentition distalization using Sliding Jig mechanics anchored by infrazygomatic crest (IZC) miniscrews.

Device: Sliding jig

Retraction Hook

ACTIVE COMPARATOR

Description: Participants in this group will undergo whole maxillary dentition distalization using Retraction Hooks mechanics anchored by infrazygomatic crest (IZC) miniscrews.

Device: retraction hooks

Interventions

Sliding jig DEVICE

participants in this group will undergo whole maxillary dentition distalization using Sliding Jig mechanics anchored by infrazygomatic crest (IZC) miniscrews.

Sliding Jig

retraction hooks DEVICE

participants in this group will undergo whole maxillary dentition distalization using Retraction Hooks mechanics anchored by infrazygomatic crest (IZC) miniscrews.

Retraction Hook

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sana'a University: lead

Study Sites (1)

Orthodontic department-faculty of dentistry- Sana'a univeristy

Sanaa, Yemen

RECRUITING

Study Officials

• Nagi H Alawdi, MSc.

  Faculty of Dentistry, Sana'a University

  PRINCIPAL INVESTIGATOR

• Fuad Luft Almutareb, prf.

  Faculty of Dentistry, Sana'a University

  STUDY DIRECTOR

Central Study Contacts

Nagi H Alawdi, MSc

CONTACT

0770499797; nagialawdi@hotmail.com

Fuad Luft Almutareb, Prf.

CONTACT

0967772275275; f.almotareb@su.edu.ye

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher, Sana'a University

Model Details: This is a randomized interventional clinical trial comparing two orthodontic mechanics for whole maxillary dentition distalization using infrazygomatic crest miniscrews in Class II patients.

Study Record Dates

• First Submitted: December 14, 2025
• First Posted: December 29, 2025
• Study Start: February 1, 2026
• Primary Completion: March 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Supporting information to be shared includes: Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), and Analytic Code. Data and supporting documents will become available within 6 months after publication of the study results and will remain accessible for 5 years.
• Access Criteria: Individual participant data and supporting documents will be available to researchers who submit a methodologically sound proposal for secondary analyses. Requests will be reviewed and approved by the Principal Investigator. A data sharing agreement must be signed to ensure privacy and ethical use of the data.

Locations

YE (1)