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

Can Tho University of Medicine and Pharmacy

Status: Completed

Conditions: Class II Division 1 Malocclusion

Treatments: Other: Skeletal, dental, soft tissue index changes in Activator group

Study type: Interventional

Funder types: Other

Identifiers

NCT06566027

LamNguyenLe FOS-CTUMP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Skeletal, dental, soft tissue index changes in Activator group

Experimental group

Description:

Activator The researcher made wax impressions of the study's patients for both the activator and treatment monitoring. The researcher instructed the patients to use the activator device for 12-14 hours daily, with a minimum requirement of 12 hours. Precise ablation of the activator created plastic surfaces that guided the process of tooth eruption.

Treatment:

Other: Skeletal, dental, soft tissue index changes in Activator group

Skeletal, dental, soft tissue index changes in EF class II standard group

Experimental group

Description:

EF class II standard The researcher monitored the study children through therapy. The research used four types of EF class II standard appliances (Orthoplus, France). Patients were required to wear the EF class II standard device for at least 12 hours every day, including the entire night and at least 2 hours during the day.

Treatment:

Other: Skeletal, dental, soft tissue index changes in Activator group