Class III Skeletal MalocclusionCLASSIII-3DNCT07179354
Comparative 3D Assessment of Class III Malocclusion Treatments
A study testing Rapid Maxillary Expansion with Face Mask (RME/FM), Mini Maxillary Protractor (MMP) and Modified Splint with Elastics and Chin Cup (Modified SEC III) in people with Class III Skeletal Malocclusion, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 9 to 12 months
- Conditions the study is for
- Class III Skeletal Malocclusion
- What is being tested?
- Rapid Maxillary Expansion with Face Mask (RME/FM), Mini Maxillary Protractor (MMP) and Modified Splint with Elastics and Chin Cup (Modified SEC III)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Feb 2024to 3 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erciyes University, Faculty of Dentistry, Department of Orthodontics
Kayseri, 38039
About this study
Official title: Comparative Assessment of Three-Dimensional Soft and Hard Tissue Changes Following Rapid Maxillary Expansion With Face Mask, Mini Maxillary Protractor, and Modified Splints, Elastics, and Chin Cup Protocols in Patients With Class III Malocclusion: A Prospective Randomized Controlled Clinical Trial
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),
Read more
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.
Read the 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
- Being tested
- Rapid Maxillary Expansion with Face Mask (RME/FM), Mini Maxillary Protractor (MMP), Modified Splint with Elastics and Chin Cup (Modified SEC III)
- Keywords
- Class III malocclusion, RME/FM, Mini maxillary protractor, SEC III, 3D stereophotogrammetry, Soft tissue, Cephalometry
- Medical subject headings
- Malocclusion, Angle Class III
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Three-dimensional changes in soft tissues
3D stereophotogrammetry used to assess overall soft tissue profile changes, including facial convexity and lip-chin parameters.
Measured: baseline to post-treatment (≈ 9 months)
Secondary outcomes (1)
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.
Measured: Baseline (pre-treatment) to post-treatment (≈ 9 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start21 Feb 2024
- Primary completion9 Jan 2025
- Study completion3 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class III Skeletal MalocclusionStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gokhan Coban, TC Erciyes University
- Investigators
- Gökhan Çoban, Associate Professor, PhD,, Principal investigator, Erciyes University, Faculty of Dentistry, Department of OrhodonticsTuba Ünlü Çiftçi, Research Assistant, Principal investigator, Erciyes University, Faculty of Dentistry, Department of Orhodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07179354
- Sponsor's protocol ID
- 2024\44
- Acronym
- CLASSIII-3D
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Assessment of Three-Dimensional Soft and Hard Tissue Changes Following Rapid Maxillary Expansion With Face Mask, Mini Maxillary Protractor, and Modified Splints, Elastics, and Chin Cup Protocols in Patients With Class III Malocclusion: A Prospective Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07179354
- Acronym / sponsor ID
- CLASSIII-3D / 2024\44
- Conditions
- Class III Skeletal Malocclusion
- Keywords
- Class III malocclusion, RME/FM, Mini maxillary protractor, SEC III, 3D stereophotogrammetry, Soft tissue, Cephalometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 21 Feb 2024 (actual)
- Primary completion
- 9 Jan 2025 (actual)
- Study completion
- 3 Mar 2025 (actual)
- First posted
- 17 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| RME/FM Group (Rapid Maxillary Expansion with Face Mask) | Experimental | Device: Rapid Maxillary Expansion with Face Mask (RME/FM)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. |
| MMP Group (Mini Maxillary Protractor) | Experimental | Device: Mini Maxillary Protractor (MMP)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 | Device: Modified Splint with Elastics and Chin Cup (Modified SEC III)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. |
| 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. |
Who may qualify
- Ages
- 9 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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°
Key exclusion criteria (6 listed)
- 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°
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | RME/FM Group (Rapid Maxillary Expansion with Face Mask) |
| 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. | Device | MMP Group (Mini Maxillary Protractor) |
| 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. | Device | Modified SEC III Group (Modified Splints with Elastics and Chin Cup) |
Primary outcome
Three-dimensional changes in soft tissues
Time frame: baseline to post-treatment (≈ 9 months)
3D stereophotogrammetry used to assess overall soft tissue profile changes, including facial convexity and lip-chin parameters.
1 secondary outcome
Two dimensional changes in skeletal parameters of the maxilla and mandible
Time frame: Baseline (pre-treatment) to post-treatment (≈ 9 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: No. 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.
Related trials for Class III Skeletal Malocclusion
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Effects of Invisalign Palatal Expander vs Rapid Palatal Expander With Facemask in Growing Class III Patients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gökhan Çoban, Associate Professor, PhD, principal investigator
Erciyes University, Faculty of Dentistry, Department of Orhodontics
Tuba Ünlü Çiftçi, Research Assistant principal investigator
Erciyes University, Faculty of Dentistry, Department of Orhodontics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid Maxillary Expansion with Face Mask (RME/FM), Mini Maxillary Protractor (MMP) and Modified Splint with Elastics and Chin Cup (Modified SEC III) in people with Class III Skeletal Malocclusion, run by TC Erciyes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Three-dimensional changes in soft tissues (time frame: baseline to post-treatment (≈ 9 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.