Evaluation of Treatment Outcomes of Interceptive Orthodontic Intervention for Class Iii Malocclusion Using Inclined Plane Appliance Combined With Variable Bracket Placement
1 other identifier
interventional
36
1 country
1
Brief 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 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2026
CompletedFirst Submitted
Initial submission to the registry
May 6, 2026
CompletedFirst Posted
Study publicly available on registry
May 12, 2026
CompletedMay 13, 2026
May 1, 2026
9 months
May 6, 2026
May 12, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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)
6 months after the start of the intervention
Study Arms (1)
Inclined Plane and Variable Bracket placement group
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Orthodontics, Ho Chi Minh City Dental Hospital
Ho Chi Minh City, Vietnam
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2026
First Posted
May 12, 2026
Study Start
July 20, 2025
Primary Completion
April 20, 2026
Study Completion
April 20, 2026
Last Updated
May 13, 2026
Record last verified: 2026-05