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

NCT ID: NCT06566027

Last Updated: 2024-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2024-06-01

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.

Conditions

Class II Division 1 Malocclusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Skeletal, dental, soft tissue index changes in Activator group

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.

Group Type: EXPERIMENTAL

Skeletal, dental, soft tissue index changes in Activator group

Intervention Type: OTHER

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)

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

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.

Group Type: EXPERIMENTAL

Skeletal, dental, soft tissue index changes in Activator group

Intervention Type: OTHER

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)

Interventions

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)

Intervention Type: OTHER

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Can Tho University of Medicine and Pharmacy

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lam Nguyen Le, PhD

Role: STUDY_DIRECTOR

Can Tho University of Medicine and Pharmacy

Locations

Department of Orthodontics, Ho Chi Minh City Dental Hospital

Ho Chi Minh City, , Vietnam

Countries

Vietnam

Other Identifiers

LamNguyenLe FOS-CTUMP

Identifier Type: -

Identifier Source: org_study_id