Google Maps

NCT07714603

Overview

NCT ID: NCT07714603
Lead Sponsor: TC Erciyes UniversityOTHER
Official Title: Evaluation of the Treatment Effects of Different Clear Aligner and Fixed Appliance Systems in Maxillary Posterior Distalization Using Infrazygomatic Crest Screws: An In-Vivo Randomized Clinical Study
Brief Summary: This study compares three different methods of moving upper back teeth backward (distalization) to create space for crowded or protruding teeth, all supported by small temporary screws placed in the cheekbone area (infrazygomatic crest screws). Participants were randomly assigned to one of three treatment types: traditional fixed braces (Pitts21 system), Invisalign clear aligners, or ClearCorrect clear aligners. The study measures how effectively each method moves the back teeth, how long treatment takes, and how comfortable and practical each method is for patients. The goal is to help orthodontists and patients choose the most effective and efficient treatment option for this type of tooth movement.
Conditions

Status and Timeline

Status: Completed
Last Update Posted: Jul 20, 2026Actual
Start Date: Jun 6, 2024Actual
Primary Completion Date: Jan 12, 2026Actual
Completion Date

Participation Criteria

Ages Eligible for Study: Child (0-17)Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Skeletal Class I (ANB angle 0-4°), dental Class II malocclusion treatable with molar distalization

Need for unilateral or bilateral distalization of the first molars in the range of 2-4.5 mm

Chronological age between 13 and 18 years, regardless of skeletal age

Normal or hypodivergent growth pattern (SN-GoGn < 39°)

Mild to moderate maxillary crowding (less than 6 mm) and minimal or no mandibular crowding (less than 3 mm)

No previously extracted maxillary teeth, excluding third molars

Erupted permanent second molars

Good oral hygiene

Healthy periodontal tissues

Exclusion Criteria:

Need for orthodontic tooth extraction or functional appliance therapy

Presence of systemic disease

Congenital or acquired craniofacial deformity involving the condyle or mandible

Poor patient cooperation

History of allergy to any metal

Pre-existing root resorption prior to treatment

Previous orthodontic treatment

Abnormal position, depth of impaction, or close proximity to adjacent anatomical structures (sinus, neurovascular structures) of the maxillary third molar that would make its surgical extraction risky

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 37Actual
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: No data available
Locations: Erciyes University, Faculty of Dentistry, Department of Orthodontics

Similar Studies

Participant Group/Arms

Group A ( Pitts21® Fixed Appliance )Active Comparator

Participants received maxillary posterior distalization using the Pitts21® fixed orthodontic appliance system, anchored with infrazygomatic crest (IZC) miniscrews and intraoral elastics for distalization force.

Device: Pitts21® fixed appliance

Group B ( Invisalign® clear aligners)Experimental

Participants received maxillary posterior distalization using Invisalign® clear aligners, anchored with infrazygomatic crest (IZC) miniscrews and intraoral elastics for distalization force.

Device: Invisalign® Clear Aligners

Group C ( ClearCorrect® clear aligners)Experimental

Participants received maxillary posterior distalization using ClearCorrect® clear aligners, anchored with infrazygomatic crest (IZC) miniscrews and intraoral elastics for distalization force.

Device: ClearCorrect Clear Aligners