Comparative 3D Assessment of Class III Malocclusion Treatments (CLASSIII-3D)

TC Erciyes University

Status: Completed

Conditions: Class III Skeletal Malocclusion

Treatments: Device: Modified Splint with Elastics and Chin Cup (Modified SEC III); Device: Rapid Maxillary Expansion with Face Mask (RME/FM); Device: Mini Maxillary Protractor (MMP)

Study type: Interventional

Funder types: Other

Identifiers

NCT07179354

2024\44

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 9 to 12 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 4 patient groups

RME/FM Group (Rapid Maxillary Expansion with Face Mask)

Experimental group

Description:

Participants in this group received rapid maxillary expansion using a bonded expander, followed by protraction with a face mask. This protocol aims to advance the maxilla in patients with Class III skeletal malocclusion.

Treatment:

Device: Rapid Maxillary Expansion with Face Mask (RME/FM)

MMP Group (Mini Maxillary Protractor)

Experimental group

Description:

This group was treated with the Mini Maxillary Protractor (MMP), a custom-designed intraoral appliance used to achieve orthopedic maxillary protraction without external devices. The aim is to promote maxillary advancement in growing Class III patients.

Treatment:

Device: Mini Maxillary Protractor (MMP)

Modified SEC III Group (Modified Splints with Elastics and Chin Cup)

Experimental group

Description:

Participants in this group were treated using modified splints with intermaxillary elastics and a chin cup (SEC III protocol). The protocol is designed to restrict mandibular growth and enhance maxillary positioning in patients with skeletal Class III malocclusion.

Treatment:

Device: Modified Splint with Elastics and Chin Cup (Modified SEC III)

Control Group (Untreated group selected from archival records)

No Intervention group

Description:

This group includes untreated patients with Class III skeletal malocclusion, selected from archival records. No intervention was administered. The group serves as a baseline comparison for evaluating treatment effects.