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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Two dimensional changes in skeletal parameters of the maxilla and mandible | Lateral cephalometric radiographs used to evaluate overall skeletal changes in maxillary and mandibular positions, as well as dental parameters including overjet and overbite. | Baseline (pre-treatment) to post-treatment (≈ 9 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erciyes University, Faculty of Dentistry, Department of Orthodontics | Kayseri | 38039 | Turkey (Türkiye) |
Individual participant data (IPD) will not be shared because the dataset is limited to a small number of pediatric patients and was collected solely for internal academic research purposes.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 21, 2024 | Sep 11, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 21, 2024 | Sep 11, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D008313 | Malocclusion, Angle Class III |
| ID | Term |
|---|---|
| D008310 | Malocclusion |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D008397 | Masks |
| ID | Term |
|---|---|
| D058257 | Surgical Attire |
| D004865 | Equipment and Supplies, Hospital |
| D004864 | Equipment and Supplies |
| D011482 | Protective Devices |
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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.
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| 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. |
|
| 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. |
|
| D000067393 | Personal Protective Equipment |
| D013523 | Surgical Equipment |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |