Comparative 3D Assessment of Class III Malocclusion Treatments

Not Applicable

Completed

• Conditions: Class III Skeletal Malocclusion

• Registration Number: NCT07179354
• Lead Sponsor: TC Erciyes University

Brief Summary

This clinical trial compares three different treatment methods used to correct jaw problems in children with Class III malocclusion (a condition where the lower jaw is positioned forward relative to the upper jaw). The treatments include:

Rapid maxillary expansion with face mask (RME/FM),

Mini maxillary protractor (MMP),

Modified splints with elastics and chin cup (SEC III).

The study aims to understand how each treatment affects the bones and soft tissues of the face, such as how much the upper jaw moves forward or the lower jaw moves backward, as well as changes in teeth alignment and facial appearance. Results showed that different treatments work best for different aspects: some are better for moving the upper jaw forward, while others are better for repositioning the lower jaw. This information helps doctors choose the most suitable treatment plan for each patient.

Detailed Description

This prospective randomized controlled clinical trial evaluates and compares the skeletal and three-dimensional soft tissue effects of three orthopedic treatment protocols in growing patients with Class III skeletal malocclusion. A total of 43 patients were randomly assigned to one of three treatment groups: rapid maxillary expansion with face mask (RME/FM), mini maxillary protractor (MMP), and modified splints with elastics and chin cup (SEC III). Additionally, a control group was formed from archival records of untreated patients with similar malocclusion characteristics.

Patients underwent comprehensive evaluation before and after treatment, including lateral cephalometric radiographs and 3D stereophotogrammetry to capture skeletal and soft tissue changes. Key parameters measured were maxillary and mandibular skeletal movements, dental inclination changes, overjet and overbite adjustments, as well as facial soft tissue displacement and angular measurements.

The study's design ensured rigorous randomization and controlled conditions to objectively assess the efficacy of each treatment protocol. The outcomes provide insight into how each method influences skeletal advancement or retrusion, dental positioning, and facial profile alterations, offering guidance for personalized treatment planning in orthodontic practice.

Study Timeline

• Study Start: 2024-02-21
• Primary Completion: 2025-01-09
• Study Completion: 2025-03-03
• Status Verified: 2025-09
• Study First Submitted: 2025-09-11
• Study First Submitted QC: 2025-09-11
• Study First Posted: 2025-09-17
• Last Update Submitted: 2025-09-17
• Last Update Posted: 2025-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• Individuals who have not completed their growth spurt (9-12 years old)
• Overjet ≤ 0 mm (patients with negative overjet must be De Nevreze positive)
• ANB ≤ 0°, Witts < 1
• Good oral hygiene and healthy periodontal tissues
• SN-GoGn angle between 26° and 38°
• No congenital or acquired tooth loss (excluding third molars)
• Body mass index (BMI) between 18-26 kg/m²
• No systemic, local, or endocrinological diseases

Exclusion Criteria

• Presence of any syndrome or developmental deformity
• Previous orthodontic treatment
• Allergy to any metal or acrylic
• Presence of any systemic disease affecting treatment
• SN-GoGn angle > 38°
• Presence of temporomandibular joint disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Three-dimensional changes in soft tissues	baseline to post-treatment (≈ 9 months)	3D stereophotogrammetry used to assess overall soft tissue profile changes, including facial convexity and lip-chin parameters.

Secondary Outcome Measures

Name	Time	Method
Two dimensional changes in skeletal parameters of the maxilla and mandible	Baseline (pre-treatment) to post-treatment (≈ 9 months)	Lateral cephalometric radiographs used to evaluate overall skeletal changes in maxillary and mandibular positions, as well as dental parameters including overjet and overbite.

Trial Locations

Locations (1)

Erciyes University, Faculty of Dentistry, Department of Orthodontics; Kayseri, Turkey (Türkiye)