| CTRI Number |
CTRI/2025/03/083619 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
26/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of fixed functional appliance with elastics in subdivision cases. |
|
Scientific Title of Study
|
To evaluate and compare skeletal and dentoalveolar changes in class II subdivision, treatment with Advansync 2 vs conventional therapy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhavika Kour Chowdhary |
| Designation |
PG second year student |
| Affiliation |
Subharti Dental College |
| Address |
Room Number 7, second floor, department of orthodontics and dentofacial orthopedics, subharti dental college, subhartipuram, meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
7018870686 |
| Fax |
|
| Email |
bhavikakourchowdhary@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep Raghav |
| Designation |
Professor and Head, Department of orthodontics and dentofacilal orthopaedics |
| Affiliation |
Subharti Dental College and Hospital |
| Address |
Room Number 7, second floor, department of orthodontics and dentofacial orthopedics, subharti dental college, subhartipuram, meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9837175914 |
| Fax |
|
| Email |
drpradeepraghav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Raghav |
| Designation |
Professor and Head, Department of orthodontics and dentofacilal orthopaedics |
| Affiliation |
Subharti Dental College and Hospital |
| Address |
Room Number 7, second floor, department of orthodontics and dentofacial orthopedics, subharti dental college, subhartipuram, meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9837175914 |
| Fax |
|
| Email |
drpradeepraghav@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Orthodontics and Dentofacial Orthopedics, Subharti Dental College, Subhartipuram, Meerut, 250005, Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Bhavika Kour Chowdhary |
| Address |
Room number 7, second floor, Department of Orthodontics and Dentofacial Orthopaedics, Subharti Dental College, Subhartipuram, Meerut, Uttar Pradesh, India |
| 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 Bhavika Kour Chowdhary |
Subharti Dental College and Hospital |
Room number 7, second floor, Department of Orthodontics and Dentofacial Orthopaedics, Subharti Dental College, Subhartipuram, Meerut
Meerut
UTTAR PRADESH |
7018870686
bhavikakourchowdhary@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University ethics Committee, swami vivekanand subharti university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Advansync2 appliance |
A Fixed Functional Appliance used to advance the mandible. It will be given once for a duration of 6 months. |
| Comparator Agent |
Orthodontic Elastics |
Orthodontic elastics are used to apply additional pressure in a specific direction to move one, or many teeth which patient is supposed to wear daily for a duration of six months |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
20.00 Year(s) |
| Gender |
Both |
| Details |
1. Angle Class II subdivision malocclusion in the permanent dentition, based on
the presence of Class Il molar relationship on one side and at least end-to end (one-half a cusp width deviation) or full cusp Class I molar relationship on
the other
2. Absence of severe crowding
3. Normal or slightly increased overbite
4. Mild or moderately increased overjet
5. Mandibular midline deviation to the Class II side
6. No functional lateral mandibular shift during closure
7. Non extraction cases
8. ANB 2º- 4º |
|
| ExclusionCriteria |
| Details |
1. Presence of active periodontal or gingival disease
2. Those with extracted or congenitally missing permanent teeth
3. Mentally challenged patients
4. Subjects with any known systemic disease
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficiency of fixed functional appliance; AdvanSync 2 with
Conventional orthodontic mechanotherapy in correction of:
• Class 2 Molar relation to Class l molar relation
• Mandibular Midline Shift |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the efficiency of fixed functional appliance; AdvanSync 2 with Conventional orthodontic mechanotherapy in correction of:
• Mandibular Midline Shift
|
6 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
|
Phase 4 |
|
Date of First Enrollment (India)
|
07/04/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The
treatment of Class II subdivision malocclusion includes a variety of
alternatives such as (a) nonextraction protocols with tip-back mechanics,
intermaxillary elastics, extraoral appliances, and fixed functional appliances;
(b) extraction treatments with one, three, or four premolar extraction
protocols; and (c) orthognathic surgery. However, treatment trends over the past 15
years show that elastics and fixed functional appliance usage have increased
from 20% to 38% and from 0% to about 15%, respectively, while the rates of
orthognathic surgery and extraction treatment decreased for these patients.1
Whereas,
the use of fixed functional appliances help in altering the position of the
jaws both sagittally and vertically, resulting in orthopedic and orthodontic
changes2, simultaneously removing the fear of surgery and also
maintaining the parent’s desire to not see their child lose teeth due to Class
II correction.3 There are many different compliance-free inter-arch
appliances including: Herbst, Mandibular Anterior Repositioning Appliance
(MARA), Forsus, and AdvanSync. From the above listed appliances, the two newest
are the Forsus and AdvanSync, which both allow concurrent treatment
Even
though, the use of Conventional therapeutic measures and fixed functional
appliances (Advansync2) are on the rise, 4 there is a definite
paucity of statistical analysis comparing the effectiveness of the
aforementioned methods in the treatment of subdivision and only a minimal
amount of case reports are present where AdvanSync 2 has been put to use for
the treatment of Class ll Subdivision cases.
Hence, the purpose of
this study is to compare the cephalometric skeletal and dentoalveolar effects of
AdvanSync 2 appliance vs. conventional orthodontic mechanotherapy
(intermaxillary elastics) in the correction of Class II subdivision
malocclusions in growing patients when used with MBT bracket system |