- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07581990
Evaluation of Treatment Outcomes of Interceptive Orthodontic Intervention for Class Iii Malocclusion Using Inclined Plane Appliance Combined With Variable Bracket Placement
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ho Chi Minh City, Vietnam
- Department of Orthodontics, Ho Chi Minh City Dental Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age: Patients between 7 and 12 years old
- Skeletal Maturity: Cervical vertebral maturation (CVM) stages CS1, CS2, or CS3
- Diagnosis: Diagnosed with skeletal Class III malocclusion on lateral cephalometric radiographs, characterized by an ANB angle < 0° and a Wits appraisal < -2mm
- Patients and their legal guardians provide informed consent to participate in the study
Exclusion Criteria:
- Dental Characteristics: Absence of anterior crossbite
- Eruption Status: Permanent maxillary central incisors have not yet erupted
- Molar Relationship: Molar relationship is not Class III according to Edward H. Angle's classification
- Skeletal/Growth Issues: Excessive mandibular growth
- Congenital Conditions: Congenitally missing maxillary first molars or presence of cleft lip and/or palate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Inclined Plane and Variable Bracket placement group
|
The treatment involves a combination of a fixed inclined plane appliance on the mandibular anterior teeth and variable bracket placement (brackets bonded with a 180-degree rotation) on the maxillary incisors . This protocol aims to promote forward maxillary growth and improve the dental relationship |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Treatment success of interceptive orthodontic intervention for skeletal Class III malocclusion
Time Frame: 6 months after the start of the intervention
|
Evaluation of treatment success based on clinical and radiographic criteria. Success is defined as achieving: Positive overjet (OJ ≥ 2mm) . Positive overbite (OB ≥ 2mm) . Angle Class I molar relationship . The assessment includes measuring changes in skeletal, dental, and soft tissue parameters using standardized lateral cephalometric radiographs and Cone Beam Computed Tomography (CBCT) |
6 months after the start of the intervention
|
Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Prof. Le Nguyen Lam CTUMP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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