Class III MalocclusionNCT07581990
Evaluation of Treatment Outcomes of Interceptive Orthodontic Intervention for Class Iii Malocclusion Using Inclined Plane Appliance Combined With Variable Bracket Placement
A study testing Inclined Plane Appliance Combined With Variable Bracket Placement in people with Class III Malocclusion and Facemask, run by Can Tho University of Medicine and Pharmacy at 1 site in Vietnam.
Trial summary
Study Title: Evaluation of Treatment Outcomes of Interceptive Orthodontic Intervention for Class III Malocclusion Using Inclined Plane Appliance Combined With Variable Bracket Placement Objective: To evaluate the clinical and radiographic outcomes of interceptive orthodontic treatment for skeletal Class III… Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Class III Malocclusion, Facemask, Inclined Plane Appliance
- What is being tested?
- Inclined Plane Appliance Combined With Variable Bracket Placement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteVietnam
- Study dates
- 20 Jul 2025to 20 Apr 2026
- 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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age: Patients between 7 and 12 years old
- Skeletal Maturity: Cervical vertebral maturation (CVM) stages CS1, CS2, or CS3
- Diagnosis: Diagnosed with skeletal Class III malocclusion on lateral cephalometric radiographs, characterized by an ANB angle < 0° and a Wits appraisal < -2mm
- Patients and their legal guardians provide informed consent to participate in the study
Who cannot join
- Dental Characteristics: Absence of anterior crossbite
- Eruption Status: Permanent maxillary central incisors have not yet erupted
- Molar Relationship: Molar relationship is not Class III according to Edward H. Angle's classification
- Skeletal/Growth Issues: Excessive mandibular growth
- Congenital Conditions: Congenitally missing maxillary first molars or presence of cleft lip and/or palate
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Department of Orthodontics, Ho Chi Minh City Dental Hospital
Ho Chi Minh City
About this study
Study Title: Evaluation of Treatment Outcomes of Interceptive Orthodontic Intervention for Class III Malocclusion Using Inclined Plane Appliance Combined With Variable Bracket Placement Objective: To evaluate the clinical and radiographic outcomes of interceptive orthodontic treatment for skeletal Class III malocclusion in children Participants: Children aged 7 to 12 years diagnosed with skeletal Class III malocclusion (ANB < 0°, Wits < -2mm) and cervical vertebral maturation stages CS1, CS2, or CS3, treated at the Ho Chi Minh City Hospital of Odonto-Stomatology from 2025 to 2026 Methodology: This is a descriptive study with a non-controlled clinical intervention The treatment involves the application of a fixed inclined plane appliance on the mandibular teeth combined with variable bracket placement (bonded at a 180-degree rotation) on the maxillary anterior teeth to promote the forward movement of the upper incisors and stimulate maxillary alveolar bone growth Evaluation: Treatment efficacy is assessed after 6 months by comparing skeletal, dental, and soft tissue changes using standardized lateral cephalometric radiographs and Cone Beam Computed Tomography (CBCT) Success is defined by achieving a positive overjet (≥2mm), overbite (≥2mm), and an Angle Class I molar relationship
- Conditions
- Class III Malocclusion, Facemask, Inclined Plane Appliance
- Being tested
- Inclined Plane Appliance Combined With Variable Bracket Placement
- 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.
Inclined Plane Appliance Combined With Variable Bracket PlacementOther
The treatment involves a combination of a fixed inclined plane appliance on the mandibular anterior teeth and variable bracket placement (brackets bonded with a 180-degree rotation) on the maxillary incisors
. This protocol aims to promote forward maxillary growth and improve the dental relationship
| Study group | Role | What they receive |
|---|---|---|
| Inclined Plane and Variable Bracket placement group | Experimental | Not described Receives: Other: Inclined Plane Appliance Combined With Variable Bracket Placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment success of interceptive orthodontic intervention for skeletal Class III malocclusion
Evaluation of treatment success based on clinical and radiographic criteria. Success is defined as achieving:
Positive overjet (OJ ≥ 2mm)
. Positive overbite (OB ≥ 2mm)
. Angle Class I molar relationship
. The assessment includes measuring changes in skeletal, dental, and soft tissue parameters using standardized lateral cephalometric radiographs and Cone Beam Computed Tomography (CBCT)
Measured: 6 months after the start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start20 Jul 2025
- Primary completion20 Apr 2026
- Study completion20 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class III MalocclusionStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Can Tho University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07581990
- Sponsor's protocol ID
- Prof. Le Nguyen Lam CTUMP
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 13 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Treatment Outcomes of Interceptive Orthodontic Intervention for Class Iii Malocclusion Using Inclined Plane Appliance Combined With Variable Bracket Placement
- ClinicalTrials.gov ID
- NCT07581990
- Acronym / sponsor ID
- Prof. Le Nguyen Lam CTUMP
- Conditions
- Class III Malocclusion, Facemask, Inclined Plane Appliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Can Tho University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 20 Jul 2025 (actual)
- Primary completion
- 20 Apr 2026 (actual)
- Study completion
- 20 Apr 2026 (actual)
- First posted
- 12 May 2026 (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.
Study Title: Evaluation of Treatment Outcomes of Interceptive Orthodontic Intervention for Class III Malocclusion Using Inclined Plane Appliance Combined With Variable Bracket Placement Objective: To evaluate the clinical and radiographic outcomes of interceptive orthodontic treatment for skeletal Class III malocclusion in children Participants: Children aged 7 to 12 years diagnosed with skeletal Class III malocclusion (ANB < 0°, Wits < -2mm) and cervical vertebral maturation stages CS1, CS2, or CS3, treated at the Ho Chi Minh City Hospital of Odonto-Stomatology from 2025 to 2026 Methodology: This is a descriptive study with a non-controlled clinical intervention The treatment involves the application of a fixed inclined plane appliance on the mandibular teeth combined with variable bracket placement (bonded at a 180-degree rotation) on the maxillary anterior teeth to promote the forward movement of the upper incisors and stimulate maxillary alveolar bone growth Evaluation: Treatment efficacy is assessed after 6 months by comparing skeletal, dental, and soft tissue changes using standardized lateral cephalometric radiographs and Cone Beam Computed Tomography (CBCT) Success is defined by achieving a positive overjet (≥2mm), overbite (≥2mm), and an Angle Class I molar relationship
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inclined Plane and Variable Bracket placement group | Experimental | Other: Inclined Plane Appliance Combined With Variable Bracket Placement |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age: Patients between 7 and 12 years old
- Skeletal Maturity: Cervical vertebral maturation (CVM) stages CS1, CS2, or CS3
- Diagnosis: Diagnosed with skeletal Class III malocclusion on lateral cephalometric radiographs, characterized by an ANB angle < 0° and a Wits appraisal < -2mm
- Patients and their legal guardians provide informed consent to participate in the study
Key exclusion criteria (5 listed)
- Dental Characteristics: Absence of anterior crossbite
- Eruption Status: Permanent maxillary central incisors have not yet erupted
- Molar Relationship: Molar relationship is not Class III according to Edward H. Angle's classification
- Skeletal/Growth Issues: Excessive mandibular growth
- Congenital Conditions: Congenitally missing maxillary first molars or presence of cleft lip and/or palate
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 |
|---|---|---|
| Inclined Plane Appliance Combined With Variable Bracket PlacementThe treatment involves a combination of a fixed inclined plane appliance on the mandibular anterior teeth and variable bracket placement (brackets bonded with a 180-degree rotation) on the maxillary incisors . This protocol aims to promote forward maxillary growth and improve the dental relationship | Other | Inclined Plane and Variable Bracket placement group |
Primary outcome
Treatment success of interceptive orthodontic intervention for skeletal Class III malocclusion
Time frame: 6 months after the start of the intervention
Evaluation of treatment success based on clinical and radiographic criteria. Success is defined as achieving: Positive overjet (OJ ≥ 2mm) . Positive overbite (OB ≥ 2mm) . Angle Class I molar relationship . The assessment includes measuring changes in skeletal, dental, and soft tissue parameters using standardized lateral cephalometric radiographs and Cone Beam Computed Tomography (CBCT)
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 13 May 2026.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inclined Plane Appliance Combined With Variable Bracket Placement in people with Class III Malocclusion and Facemask, run by Can Tho University of Medicine and Pharmacy at 1 site in Vietnam.
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 4 inclusion and 5 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 13 May 2026. 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 Vietnam. 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?
Treatment success of interceptive orthodontic intervention for skeletal Class III malocclusion (time frame: 6 months after the start of the intervention). 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 13 May 2026.