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

NCT07581990 — Not applicable, Completed, 36 participants, Can Tho University of Medicine and Pharmacy

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Registry	NCT07581990
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	36 (Actual)
Sponsor	Can Tho University of Medicine and Pharmacy (Other)
Conditions	Class III Malocclusion, Facemask, Inclined Plane Appliance
Interventions	Inclined Plane Appliance Combined With Variable Bracket Placement (Other)
Dates	start 2025-07-20, primary completion 2026-04-20, completion 2026-04-20, first posted 2026-05-12, last updated 2026-05-13
Locations	1 site in Vietnam

-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

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+Arms and interventions

Arm	Type	Interventions	Description
Inclined Plane and Variable Bracket placement group	Experimental	Other: Inclined Plane Appliance Combined With Variable Bracket Placement

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

+Outcome measures

Primary outcomes

Treatment success of interceptive orthodontic intervention for skeletal Class III malocclusion [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)

+Eligibility

Sex: All, ages: 7 Years to 12 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Department of Orthodontics, Ho Chi Minh City Dental Hospital	Ho Chi Minh City	Vietnam

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