Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06566027
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
Activator vs the EF Class II Standard in the Treatment of Severe Overjet in Angle Class II Division 1 Malocclusion
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 97 131 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 studys endpoint was reached
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 97 131 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 studys 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 97 131 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 studys 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 340HVPCT-H signed the study on April 12 2023
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None