Evaluation of Treatment Outcomes of Interceptive Orthodontic Intervention for Class Iii Malocclus… (NCT07581990) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Treatment Outcomes of Interceptive Orthodontic Intervention for Class Iii Malocclusion Using Inclined Plane Appliance Combined With Variable Bracket Placement
Vietnam36 participantsStarted 2025-07-20
Plain-language summary
Study Title: Evaluation of Treatment Outcomes of Interceptive Orthodontic Intervention for Class III Malocclusion Using Inclined Plane Appliance Combined With Variable Bracket Placement Objective: To evaluate the clinical and radiographic outcomes of interceptive orthodontic treatment for skeletal Class III malocclusion in children Participants: Children aged 7 to 12 years diagnosed with skeletal Class III malocclusion (ANB \< 0°, Wits \< -2mm) and cervical vertebral maturation stages CS1, CS2, or CS3, treated at the Ho Chi Minh City Hospital of Odonto-Stomatology from 2025 to 2026 Methodology: This is a descriptive study with a non-controlled clinical intervention The treatment involves the application of a fixed inclined plane appliance on the mandibular teeth combined with variable bracket placement (bonded at a 180-degree rotation) on the maxillary anterior teeth to promote the forward movement of the upper incisors and stimulate maxillary alveolar bone growth Evaluation: Treatment efficacy is assessed after 6 months by comparing skeletal, dental, and soft tissue changes using standardized lateral cephalometric radiographs and Cone Beam Computed Tomography (CBCT) Success is defined by achieving a positive overjet (≥2mm), overbite (≥2mm), and an Angle Class I molar relationship
Who can participate
Age range
7 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Treatment success of interceptive orthodontic intervention for skeletal Class III malocclusion
Timeframe: 6 months after the start of the intervention
Trial details
NCT IDNCT07581990
SponsorCan Tho University of Medicine and Pharmacy