NCT07581990

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2026

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 12, 2026

Completed
Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

9 months

First QC Date

May 6, 2026

Last Update Submit

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

EXPERIMENTAL
Other: Inclined Plane Appliance Combined With Variable Bracket Placement

Interventions

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

Inclined Plane and Variable Bracket placement group

Eligibility Criteria

Age7 Years - 12 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17)

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

Location

Related Links

MeSH Terms

Conditions

Malocclusion, Angle Class III

Condition Hierarchy (Ancestors)

MalocclusionTooth DiseasesStomatognathic Diseases

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

Locations