Activator vs the EF Class II Standard in the Treatment of Severe Overjet in Angle Class II Division 1 Malocclusion

Not Applicable

Completed

• Conditions: Class II Division 1 Malocclusion

• Registration Number: NCT06566027
• Lead Sponsor: Can Tho University of Medicine and Pharmacy

Brief Summary

Objective: The purpose of this study was to compare the clinical effectiveness of reducing severe overjet in Angle Class II division 1 malocclusion between Activator and the EF (Functional Education) class II standard in treating.

Methods: A randomized clinical trial was conducted on a total of ̉60 patients with an Angle Class II, division 1 malocclusion (ANB angle ≥ 4°, basic normal maxillary status), and an overjet of ≥ 6 mm in the developmental stage (CS1-CS3) who were eligible for the study. Thus, the sample consisted of 60 subjects (29 girls and 31 boys) with a mean age of 9.7 ± 1.31 years. The investigators designed the study to treat patients, randomly assigning them by lottery to receive either an activator or the EF (Functional Education) class II standard. The activator versus the EF (Functional Education) class II standard group consisted of 30 subjects (17 girls, 13 boys) and 30 subjects (12 girls, 18 boys), respectively. The changes in skeletal, dental, and soft tissue were recorded before, at 6 months of treatment. Blinding was not performed. After six months of treatment, the study's endpoint was reached.

Detailed Description

A randomized clinical trial was conducted on a total of ̉60 patients with an Angle Class II, division 1 malocclusion, and an overjet of ≥6 mm who were eligible for the study. Thus, the sample consisted of 60 subjects (29 girls and 31 boys) with a mean age of 9.7 ± 1.31 years. We designed the study to treat patients, randomly assigning them by lottery to receive either an activator or the EF (Functional Education) class II standard. The activator versus the EF (Functional Education) class II standard group consisted of 30 subjects (17 girls, 13 boys) and 30 subjects (12 girls, 18 boys), respectively. The changes in skeletal, dental, and soft tissue were recorded before, at 6 months of treatment. Blinding was not performed. After six months of treatment, the study's endpoint was reached and then selected those who achieved the standards for sampling at Can Tho University of Medicine and Pharmacy. The Can Tho University of Medicine and Pharmacy Ethics Council in Biomedical Research No. 23. 340.HV/PCT-H signed the study on April 12, 2023.

Study Timeline

• Study Start: 2023-04-01
• Primary Completion: 2024-05-01
• Study Completion: 2024-06-01
• Status Verified: 2024-08
• Study First Submitted: 2024-08-08
• Study First Submitted QC: 2024-08-20
• Last Update Submitted: 2024-08-20
• Study First Posted: 2024-08-22
• Last Update Posted: 2024-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Vietnamese children between the ages of 7 and 12 with central incisors erupted
• Angle Class II division 1 malocclusion (ANB angle ≥ 4°, basic normal maxillary status)
• Severe overjet ≥ 6mm
• The developmental stage (CS1-CS3)
• No previous orthodontic treatment
• Agreeing to engage in the study

Exclusion Criteria

• The young with crossbite
• Severe crowding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To compare the clinical effectiveness of reducing severe overjet in Angle Class II division 1 malocclusion between Activator and the EF (Functional Education) class II standard in treating.	6 months	Every month, the research participants from both groups underwent regular re-examinations, during which they collected cephalometric radiographs for assessment at two specific time points: T0, before treatment, and T1 after 6 months of treatment. A Planmeca ProMax® 2D digital X-ray system (Planmeca, Poland) captured the cephalometric radiographs. The Dental Hospital used the licensed AudaxCeph program to accurately draw lines and perform measurements on the cephalometric images.

Trial Locations

Locations (1)

Department of Orthodontics, Ho Chi Minh City Dental Hospital; 🇻🇳 Ho Chi Minh City, Vietnam