Using infrazygomatic-crest versus interradicular mini-implants to retract upper front teeth in Class II Division 1 malocclusion

MINI IMPLANTS PLACED AT INFRAZYGOMATIC CREST VERSUS INTERRADICULAR SITES A RANDOMIZED CLINICAL TRIAL.

This will test whether mini-implants placed in the infrazygomatic crest or between tooth roots better help pull back the upper front teeth in non-growing patients with Class II Division 1 malocclusion.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 30 Years
• Sex: All
• Sponsor: Postgraduate Institute of Dental Sciences Rohtak (other)
• Locations: 1 site (Rohtak, Haryana)
• Trial ID: NCT07405905 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, non-pharmacological trial compares two mini-implant insertion sites for en-masse retraction after bilateral maxillary first premolar extraction using 0.022" MBT preadjusted edgewise appliances. Patients are randomly assigned to receive either infrazygomatic-crest or interradicular mini-implants as anchorage for retraction of the upper anterior teeth. Outcomes include objective treatment changes in tooth and soft-tissue positions and subjective perceptions from patients and orthodontists. The single-center study is conducted at the Department of Orthodontics and Dentofacial Orthopaedics with oral surgery support at PGIDS Rohtak under institutional ethical approval.

Who should consider this trial

Good fit: Ideal candidates are non-growing patients with bilateral Class II molar relationships, all permanent teeth to the second molars present, no or minor maxillary crowding, and a horizontal-to-average growth pattern.

Not a fit: Patients with prior fixed orthodontic treatment, crossbite, a vertical growth pattern, systemic bone or growth disorders, poor oral hygiene, cleft conditions, or those unwilling to complete follow-up are unlikely to benefit.

Why it matters

Potential benefit: If successful, the chosen implant placement could make upper-anterior retraction more predictable and efficient, improving lip position and facial profile while providing better anchorage control.

How similar studies have performed: Mini-implants are widely used and have shown effectiveness as anchorage for en-masse retraction, but direct comparisons between infrazygomatic and interradicular placements have produced mixed results.

Eligibility criteria

Inclusion Criteria:

1. Non growing patients
2. Bilateral Class II molar relationship at pre-treatment.
3. All permanent teeth upto the second molars should be present.
4. No or minor crowding in the maxillary arch.
5. Horizontal to average growth pattern.

Exclusion Criteria:

1. Subjects with a history of fixed orthodontic treatment.
2. Crossbite
3. Vertical growth pattern
4. Any systemic disease affecting bone and general growth
5. Poor oral hygiene
6. Cleft patients
7. Patients who fail to follow up or undergo complete treatment

Where this trial is running

Rohtak, Haryana

• Post Graduate Institute of Dental Sciences, Rohtak, Haryana 124001 — Rohtak, Haryana, India (RECRUITING)

Study contacts

• Study coordinator: Sonal chowdhary, MDS

Conditions: CLASS II DIVISION 1 MALOCCLUSION