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

NCT06566027 | Completed DMC

• 1 other identifier: LamNguyenLe FOS-CTUMP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Class II Division 1 Malocclusion

Keywords

Angle CII division 1, Activator, EF CII standard, severe OJ

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Skeletal, dental, soft tissue index changes in Activator group

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Interventions

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• The young with crossbite
• Severe crowding

Sponsors & Collaborators

• Can Tho University of Medicine and Pharmacy: lead

Study Sites (1)

Department of Orthodontics, Ho Chi Minh City Dental Hospital

Ho Chi Minh City, Vietnam

Location

MeSH Terms

Conditions

Malocclusion, Angle Class II

Interventions

Dental Health Services

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Health Services; Health Care Facilities Workforce and Services

Study Officials

• Lam Nguyen Le, PhD

  Can Tho University of Medicine and Pharmacy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: August 8, 2024
• First Posted: August 22, 2024
• Study Start: April 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: June 1, 2024
• Last Updated: August 22, 2024

Record last verified: 2024-08

Locations

VN (1)