| CTRI Number |
CTRI/2026/04/107415 [Registered on: 02/04/2026] Trial Registered Prospectively |
| Last Modified On: |
17/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to assess the airway changes and jaw joint changes in patients with backwardly placed lower jaw after giving an appliance for correction |
|
Scientific Title of Study
|
Evaluation of oro-pharyngeal functional unit and TMJ changes in skeletal class-II patients after fixed functional appliance therapy- a randomized clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Biradavolu Sri Sivani |
| Designation |
Post graduate student |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Orthodontics and Dentofacial Orthopedics, Block no.3, Second floor, Room no.6, Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9666392636 |
| Fax |
|
| Email |
srisivani2636@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Anoosha |
| Designation |
Associate Professor |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Orthodontics and Dentofacial Orthopedics, Block no.3, Secondfloor, Room no.6, Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
7674926249 |
| Fax |
|
| Email |
anoosham@vdc.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Pradeep |
| Designation |
Associate Professor |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Orthodontics and Dentofacial Orthopedics, Block no.3, Second floor, Room no.6, Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9603217449 |
| Fax |
|
| Email |
kpradeep@vdc.edu.in |
|
|
Source of Monetary or Material Support
|
| Vishnu Dental College, Vishnupur, Bhimavaram, West Godavari District, Andhra Pradesh, India-534202
|
|
|
Primary Sponsor
|
| Name |
Dr Biradavolu Sri Sivani |
| Address |
Post Graduate Student, Department of Orthodontics and Dentofacial Orthopedics, Block no.3, Second floor, Room no.6, Vishnu Dental College, Vishnupur, Bhimavaram, West Godavari district, AndhraPradesh, India-534202 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr Biradavolu Sri Sivani |
Vishnu Dental College |
Department of Orthodontics and Dentofacial Orthopedics, Block no.3, Second floor, Room no.6, Vishnu Dental College, Vishnupur, Bhimavaram-534202
West Godavari
ANDHRA PRADESH |
9666392636
srisivani2636@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe,Vishnu Dental ,College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M264||Malocclusion, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Advansync2 fixed functional appliance |
Advansync2 fixed functional appliance will be given in patients with skeletal classII malocclusion and mandibular retrusion for assessing airway changes,TMJchanges and hyoid bone position. CBCT radiograph will be taken before and after giving appliance for a time period of 6months |
| Comparator Agent |
Power scope fixed functional appliance |
Power scope fixed functional appliance will be given in patients with skeletal classII malocclusion and mandibular retrusion for assessing airway changes,TMJchanges and hyoid bone position. CBCT radiograph will be taken before and after giving appliance for a time period of 6months |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1)Skeletal class II malocclusion (ANB greater than or equal to 4-6degrees), overjet greater than or equal to 4-7 mm
2)Class II malocclusion due to mandibular retrusion
3)Positive visual treatment objective |
|
| ExclusionCriteria |
| Details |
1)History of tonsillectomy or adenoidectomy, craniofacial syndromes or congenital anomalies
2) Previously orthodontic treated patients
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the Volumetric pharyngeal airway dimensions, TMJ parameters and Hyoid bone position in patients treated with fixed functional therapy before and after intervention |
Baseline and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Comparative effectiveness of AdvanSync 2 vs PowerScope appliances on airway and TMJ changes
2)Treatment duration and patient compliance over 6–8 months
3)Functional implications: improvement in breathing, chewing efficiency, and jaw function post treatment
|
Baseline and 6 months |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
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)
|
13/04/2026 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This randomized clinical trial will evaluate skeletal Class II patients with mandibular retrusion treated using fixed functional appliances. A total of 16 patients will be recruited and divided into two groups: AdvanSync 2 (n=8) and PowerScope (n=8). Each patient will undergo treatment for 6–8 months. Informed consents will be taken from both parent and participant. Cone Beam Computed Tomography (CBCT) scans will be taken at baseline (T0) and after intervention (T1) to assess changes. Primary outcomes include pharyngeal airway dimensions (area, volume), hyoid bone position, and temporomandibular joint (TMJ) remodeling parameters (condylar head volume, length, width, height, inter-condylar distance, glenoid fossa dimensions, and articular joint spaces). Measurements will be performed using Planmeca Romexis software. Data will be statistically analyzed to compare treatment effects between appliances. All imaging will follow ALARA principles to ensure minimal radiation exposure. The study aims to identify which appliance provides better functional and structural outcomes, thereby improving orthodontic treatment safety and effectiveness. |