Comparative 3D Assessment of Class III Malocclusion Treatments

NCT07179354 | Completed

• 1 other identifier: 2024\44
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Class III Skeletal Malocclusion

Keywords

Class III malocclusion; RME/FM; Mini maxillary protractor; SEC III; 3D stereophotogrammetry; Soft tissue; Cephalometry

Outcome Measures

Primary Outcomes (1)

• Three-dimensional changes in soft tissues

  3D stereophotogrammetry used to assess overall soft tissue profile changes, including facial convexity and lip-chin parameters.

  baseline to post-treatment (≈ 9 months)

Secondary Outcomes (1)

• Two dimensional changes in skeletal parameters of the maxilla and mandible

  Baseline (pre-treatment) to post-treatment (≈ 9 months)

Study Arms (4)

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

EXPERIMENTAL

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.

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

MMP Group (Mini Maxillary Protractor)

EXPERIMENTAL

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.

Device: Mini Maxillary Protractor (MMP)

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

EXPERIMENTAL

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.

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

Control Group (Untreated group selected from archival records)

NO INTERVENTION

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.

Interventions

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

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

Mini Maxillary Protractor (MMP) 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.

MMP Group (Mini Maxillary Protractor)

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

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

Eligibility Criteria

• Age: 9 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University, Faculty of Dentistry, Department of Orthodontics

Kayseri, 38039, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Malocclusion, Angle Class III

Interventions

Masks

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Surgical Attire; Equipment and Supplies, Hospital; Equipment and Supplies; Protective Devices; Personal Protective Equipment; Surgical Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Gökhan Çoban, Associate Professor, PhD,

  Erciyes University, Faculty of Dentistry, Department of Orhodontics

  PRINCIPAL INVESTIGATOR

• Tuba Ünlü Çiftçi, Research Assistant

  Erciyes University, Faculty of Dentistry, Department of Orhodontics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This study uses a parallel assignment design, where participants with Class III skeletal malocclusion are randomly assigned to one of three treatment groups: rapid maxillary expansion with face mask (RME/FM), mini maxillary protractor (MMP), or modified splints with elastics and chin cup (SEC III). Additionally, a control group consisting of untreated patients with similar malocclusion characteristics from archival records is included for comparison. Each treatment group receives its specific intervention simultaneously, and outcomes are compared among all groups to evaluate the efficacy of each protocol.

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 17, 2025
• Study Start: February 21, 2024
• Primary Completion: January 9, 2025
• Study Completion: March 3, 2025
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)