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

Sponsored by Can Tho University of Medicine and Pharmacy

About this trial

Last updated 2 years ago

Study ID

LamNguyenLe FOS-CTUMP

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

All Ages
All Sexes

Trial Timing

Ended 2 years ago

What is this trial 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.

What are the participation requirements?

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