Comparative 3D Assessment of Class III Malocclusion Treatments

NCT ID: NCT07179354

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-21
• Study Completion Date: 2025-03-03

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.

Conditions

Class III Skeletal Malocclusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: EXPERIMENTAL

Rapid Maxillary Expansion with Face Mask (RME/FM)

Intervention Type: DEVICE

A tooth- and tissue-borne rapid maxillary expansion appliance with an expansion screw was used to achieve transverse maxillary expansion, followed by Petit-type face mask therapy. Expansion protocol: two quarter-turns per day for 10-14 days, then one quarter-turn per day until cusp-to-cusp relationship was achieved. Face mask elastics applied 16 hours/day at 350-500 g per side, with a 30° downward and forward vector relative to the occlusal plane.

MMP Group (Mini Maxillary Protractor)

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.

Group Type: EXPERIMENTAL

Mini Maxillary Protractor (MMP)

Intervention Type: DEVICE

An intraoral mini maxillary protraction appliance was used to advance the maxilla. Force was applied through intraoral elastics connected to intraoral anchorage units. The protocol was designed to deliver orthopedic forward traction of the maxilla without an external face mask.

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

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

A modified splint appliance combined with intraoral elastics and an orthopedic chin cup was used to achieve skeletal mandibular retrusion and Class III correction. The appliance applied orthopedic forces through combined vertical and horizontal components, promoting backward positioning of the mandible while maintaining transverse maxillary relationships.

Control Group (Untreated group selected from archival records)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Rapid Maxillary Expansion with Face Mask (RME/FM)

A tooth- and tissue-borne rapid maxillary expansion appliance with an expansion screw was used to achieve transverse maxillary expansion, followed by Petit-type face mask therapy. Expansion protocol: two quarter-turns per day for 10-14 days, then one quarter-turn per day until cusp-to-cusp relationship was achieved. Face mask elastics applied 16 hours/day at 350-500 g per side, with a 30° downward and forward vector relative to the occlusal plane.

Intervention Type: DEVICE

Mini Maxillary Protractor (MMP)

An intraoral mini maxillary protraction appliance was used to advance the maxilla. Force was applied through intraoral elastics connected to intraoral anchorage units. The protocol was designed to deliver orthopedic forward traction of the maxilla without an external face mask.

Intervention Type: DEVICE

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

A modified splint appliance combined with intraoral elastics and an orthopedic chin cup was used to achieve skeletal mandibular retrusion and Class III correction. The appliance applied orthopedic forces through combined vertical and horizontal components, promoting backward positioning of the mandible while maintaining transverse maxillary relationships.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 9 Months
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TC Erciyes University

OTHER

Sponsor Role: lead

Responsible Party

Gokhan Coban

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gökhan Çoban, Associate Professor, PhD,

Role: PRINCIPAL_INVESTIGATOR

Erciyes University, Faculty of Dentistry, Department of Orhodontics

Tuba Ünlü Çiftçi, Research Assistant

Role: PRINCIPAL_INVESTIGATOR

Erciyes University, Faculty of Dentistry, Department of Orhodontics

Locations

Erciyes University, Faculty of Dentistry, Department of Orthodontics

Kayseri, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2024\44

Identifier Type: -

Identifier Source: org_study_id