| CTRI Number |
CTRI/2025/09/094227 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Checking changes in jawbone support after using the AdvanSync appliance with 3D dental scans. |
|
Scientific Title of Study
|
Assessment of alveolar bone support alterations following Advansync appliance therapy: A CBCT-based analysis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harshali Zavar |
| Designation |
MDS 2nd year |
| Affiliation |
School of Dental Sciences Krishna Institute of Medical Sciences Maharashtra |
| Address |
Department of Orthodontics and Dentofacial Orthopedics, Room no 41
Satara
MAHARASHTRA
415539
India |
| Phone |
08805478250 |
| Fax |
|
| Email |
harshalizavar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Channamallappa R. Ganiger |
| Designation |
Professor and head of Department |
| Affiliation |
School of Dental Sciences Krishna Institute of Medical Sciences Maharashtra |
| Address |
Department of Orthodontics and Dentofacial Orthopedics, room no 41
Satara
MAHARASHTRA
415539
India |
| Phone |
09986841519 |
| Fax |
|
| Email |
zavarharshali@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Harshali Zavar |
| Designation |
MDS 2nd year |
| Affiliation |
School of Dental Sciences Krishna Institute of Medical Sciences Maharashtra |
| Address |
Department of Orthodontics and Dentofacial Orthopedics, Room no-41
Satara
MAHARASHTRA
415539
India |
| Phone |
08805478250 |
| Fax |
|
| Email |
harshalizavar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Krishna Vishwa Vidhyapeeth, School of dental sciences |
| Address |
Krishna Vishwa Vidyapeeth, Malkapur, Karad, Satara, Maharashtra, 415539 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Harshali Zavar |
School of Dental Sciences |
Department of orthodontics and dentofacial orthopedics, NO- 41
Satara
MAHARASHTRA |
08805478250
harshalizavar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Krishna Vishwa Vidyapeeth Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Orthodontic patients with skeletal class II malocclusion, retrognathic mandible with no underlying systemic disease or condition |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
Patients having permanent dentition
Patients with Class II Division I malocclusion, Convex profile; short mentocervical line; overjet of equal or greater than 5 mm. |
|
| ExclusionCriteria |
| Details |
Patients with poor oral hygiene.
Patients with extreme vertical growth pattern and prior orthodontic treatment
Patients on regular antibiotic, steriods and anti-inflammatory drugs |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of alveolar bone thickness around mandibular incisors at T0 and T1 phase of therapy. |
5 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Measurement of buccal, Lingual and total bone thickness at crestal, midroot and apical levels of mandibular incisors at T0 and T1 of therapy. |
5 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is conducted to assess the alveolar bone changes seen around mandibular lower incisors on completion with Advansync appliance therapy. A fixed functional appliance is advised for pubertal and post-pubertal patients with skeletal class II malocclusion and a retrusive mandible with a convex profile. The common adverse effect of fixed functional therapy is proclination of lower incisors and which causes changes in alveolar bone thickness around mandibular lower incisors. The balanced occlusion demands that teeth to be placed in the center of the alveolar bone to maintain healthy periodontium and reduce treatment replase tendency. The study will assess the thickness of alveolar bone at the start of treatment (T0) and end of functional therapy treatment (T1) at three different points: crestal, midroot, and apical levels of mandibular incisors. |