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

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.

Study Overview

• Status: Completed
• Conditions: Class II Division 1 Malocclusion
• Intervention / Treatment: Other: Skeletal, dental, soft tissue index changes in Activator group

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Ho Chi Minh City, Vietnam
    • Department of Orthodontics, Ho Chi Minh City Dental Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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)
Experimental: 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.	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	6 months

Collaborators and Investigators

• Sponsor: Can Tho University of Medicine and Pharmacy
• Investigators: Study Director: Lam Nguyen Le, PhD, Can Tho University of Medicine and Pharmacy

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Actual): May 1, 2024
• Study Completion (Actual): June 1, 2024

Study Registration Dates

• First Submitted: August 8, 2024
• First Submitted That Met QC Criteria: August 20, 2024
• First Posted (Actual): August 22, 2024

Study Record Updates

• Last Update Posted (Actual): August 22, 2024
• Last Update Submitted That Met QC Criteria: August 20, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Angle CII division 1, Activator, EF CII standard, severe OJ
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion; Malocclusion, Angle Class II
• Other Study ID Numbers: LamNguyenLe FOS-CTUMP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No