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Completed

NCT Number: NCT07581990

Evaluation of Treatment Outcomes of Interceptive Orthodontic Intervention for Class Iii Malocclusion Using Inclined Plane Appliance Combined With Variable Bracket Placement

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

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Key information

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthodontics, Ho Chi Minh City Dental Hospital

Ho Chi Minh City, Vietnam

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Inclined Plane Appliance Combined With Variable Bracket Placement

Other

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

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Can Tho University of Medicine and Pharmacy

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 12, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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