NCT06566027

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

A Comparison of the Effectiveness of Activator Versus the EF (Functional Education) Class II Standard in the Treatment of Severe Overjet in Angle Class II Division 1 Malocclusion in Vietnamese Population: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Can Tho University of Medicine and Pharmacy · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Class II Division 1 Malocclusion

Interventions

Type	Name	Description
OTHER	Skeletal, dental, soft tissue index changes in Activator group	After being interviewed and provided by a doctor with two kinds of appliances (Activator and EF class II standard) for treating class II malocclusion, the patients choose their appliance. The patients were separated into two groups (30 in each). Group 1 was treated with an Activator appliance (Activator group), whereas Group 2 was treated with an EF class II standard appliance (EF line group)

Timeline

• Start date: 2023-04-01
• Primary completion: 2024-05-01
• Completion: 2024-06-01
• First posted: 2024-08-22
• Last updated: 2024-08-22

Locations

1 site across 1 country: Vietnam