Skeletal and dentalveolar changes in individuals treated with Advansync 2

Phase 1/2

Not yet recruiting

Conditions: Disorder of teeth and supporting structures, unspecified,

Registration Number: CTRI/2022/09/045772

Lead Sponsor: K Rajamanickam

Brief Summary: **Comparison of skeletal and dentoalveolar changes in skeletal class II correction with Advansync 2 between two different bracket prescriptions- A randomized controlled trial.**

**Aim:** To compare the skeletal and dentoalveolar changes in skeletal class II correction achieved with Advansync 2 between two different bracket prescriptions.

**Objective and rationale**

To evaluate whether lower incisor proclination can be controlled when Advansync is used in conjunction with Damon. True and adequate mandibular advancement is achieved by maintaining average lower incisor inclination in the mandibular basal bone. Self ligating bracket system mainly achieves tooth alignment and relieves crowding by **arch expansion**. Arch expansion in Damon self ligating system is greater than that achieved in conventional pre-adjusted edgewise appliance. Excessive proclination of the lower incisors restrict forward rotation of the mandible and also hinders mandibular advancement. Thus this study was undertaken to evaluate the amount of mandibular advancement and other associated skeletal, dentoalveolar and soft tissue changes achieved by both the systems when used in conjunction with Advansync 2 appliance.

**Sample size: 22 patients**

Group 1: 11(Damon with Advansync) Group 2: 11 (MBT with Advansync)

**Methodology:**

22 growing subjects with Skeletal class II malocclusion selected based on their CVMI staging. Group A (11 subjects) to be treated with MBT with Advansync 2, and Group B (11 subjects) to be treated with Damon Q with Advansync 2. Sample size was determined using G power version 3.0.1 with power of 0.8. Simple random sampling to be done. Case records to be taken for each patient at pre- AdvanSync2 (T1) and post-AdvanSync2 (T2), which includes cephalometric radiographs, extraoral, and intraoral photographs. Informed consent to be obtained from each participant for the use of their case records for scientific research and publication

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 22

Inclusion Criteria

Skeletal class II due to retrognathic mandible ANB>4 degrees Growing children.

Exclusion Criteria

Growing children with Skeletal class II due to prognathic maxillary Adults with class II malocclusion.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
lower incisor proclamation	initial, 6 months
mandibular length	initial, 6 months
SNB	initial, 6 months
ANB	initial, 6 months

Secondary Outcome Measures

Name	Time	Method
Soft tissue changes	initial, 6 months

Trial Locations

Locations (1): Saveetha Dental College and Hospitals, Department of Orthodontics Clinic 27,
🇮🇳
Thiruvallur, TAMIL NADU, India
Saveetha Dental College and Hospitals, Department of Orthodontics Clinic 27,
🇮🇳Thiruvallur, TAMIL NADU, India
Preethi Rajamanickam
Principal investigator
9003228400
preethirajamanickams@gmail.com