Class II Division 1 Malocclusion Clinical Trial
Official title:
"Evaluation of Treatment Effects of Two Different Fixed Functional Appliances in Patients With Class II Div 1 Malocclusion Using CBCT- A Randomized Controlled Clinical Study"
NCT number | NCT03296644 |
Other study ID # | sonal ortho |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 16, 2016 |
Est. completion date | April 2018 |
Verified date | April 2019 |
Source | Postgraduate Institute of Dental Sciences Rohtak |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The main objective of this prospective, controlled clinical study is:
1. To compare the treatment effects of PowerScope2 and Forsus Fatigue Resistant Device in
patients with Class II divison1 malocclusion.
2. To compare the treatment effects of PowerScope2 and Forsus Fatigue Resistant Device with
the control group.
The null hypothesis for this study is that Forsus and PowerScope2 are equally effective in
the treatment of ClassII div1 malocclusion.
Status | Completed |
Enrollment | 42 |
Est. completion date | April 2018 |
Est. primary completion date | April 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 17 Years |
Eligibility |
Inclusion Criteria: - Patients in active growth period - Skeletal Class II malocclusion - Normal or mildly prognathic maxilla - Retrognathic mandible. - Increased overjet, not less than 5 mm. - Horizontal to average growth pattern - Positive pretreatment visual treatment objective (VTO). - Minimum crowding in dental arches. - Treatment completed without any permanent teeth extracted (excluding third molars). Exclusion Criteria:• Subjects with a history of orthodontic treatment - Anterior open bite - Severe proclination and crowding of anterior teeth - Any systemic disease affecting bone and generalgrowth - Vertical growth pattern - Patient who fails to follow up or undergo complete treatment |
Country | Name | City | State |
---|---|---|---|
India | Post Graduate Institute of Dental Sciences | Rohtak | Haryana |
Lead Sponsor | Collaborator |
---|---|
Postgraduate Institute of Dental Sciences Rohtak |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | mandibular length | changes in mandibular length after intervention | 20 months | |
Primary | oropharyngeal volume | changes in oropharyngeal volumes after intervention | 20 months | |
Primary | condylar changes | condylar changes after intervention | 20 months | |
Primary | patient experiences | patient experiences with Forsus and PowerScope | 20 months | |
Primary | pancherz analysis | pancherz analysis after intervention | 20 months | |
Primary | soft tissue changes | soft tissue changes after intervention | 20 months |
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