| CTRI Number |
CTRI/2024/04/065386 [Registered on: 08/04/2024] Trial Registered Prospectively |
| Last Modified On: |
04/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of changes in lower jaw with intermaxillary elastics combined with anterior bite turbos. |
|
Scientific Title of Study
|
Evaluation of the skeletal, dental & soft tissue changes with intermaxillary elastics combined with anterior bite turbos for the correction of skeletal Class II malocclusion: A pilot study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saugat Ray |
| Designation |
Reader & Instructor |
| Affiliation |
AFMC (Armed Forces Medical College) |
| Address |
Division of Orthodontics
Dept of Dental Surgery & OHS
AFMC (Armed Forces Medical College)
Solapur Road
Pune
MAHARASHTRA
411040
India |
| Phone |
9057443123 |
| Fax |
|
| Email |
saugatray80@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Saugat Ray |
| Designation |
Reader & Instructor |
| Affiliation |
AFMC (Armed Forces Medical College) |
| Address |
Division of Orthodontics
Dept of Dental Surgery & OHS
AFMC (Armed Forces Medical College)
Solapur Road
MAHARASHTRA
411040
India |
| Phone |
9057443123 |
| Fax |
|
| Email |
saugatray80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Saugat Ray |
| Designation |
Reader & Instructor |
| Affiliation |
AFMC (Armed Forces Medical College) |
| Address |
Division of Orthodontics
Dept of Dental Surgery & OHS
AFMC (Armed Forces Medical College)
Solapur Road
MAHARASHTRA
411040
India |
| Phone |
9057443123 |
| Fax |
|
| Email |
saugatray80@gmail.com |
|
|
Source of Monetary or Material Support
|
| DGAFMS (Anveshan Project)
M Block
Integrated HQ Ministry of Defence
New Delhi
110001 |
|
|
Primary Sponsor
|
| Name |
Director General Armed Forces Medical Services |
| Address |
M Block
Ministry of Defence
New Delhi 01 |
| Type of Sponsor |
Government funding agency |
|
|
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 Saugat Ray |
Armed Forces Medical College |
Division of Orthodontics
Dept of Dental Surgery & OHS
Armed Forces Medical College
Solapur Road
Pune
MAHARASHTRA |
9057443123
saugatray80@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, AFMC, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q758||Other specified congenital malformations of skull and face bones, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intermaxillary elastics combined with anterior bite turbos |
Use of intermaxillary elastics combined with anterior bite turbos for mandibular advancement in skeletal Class II patients. Intermaxillary elastics will be applied from TAD distal to upper canines bilaterally and lower molar hooks. The skeletal,
dental and soft tissue changes will be observed after functional phase.
Duration of intervention: 03 years |
| Comparator Agent |
Not Applicable |
Not Applicable
Duration: Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1. Class II Div 1 malocclusion with ANB more than 4 degrees
2. Bilateral Class II or Half Cusp Class II molar relation
3. Patients with cephalometric features of orthognathic maxilla and retro gnathic mandible
4. Positive visual treatment objective
5. CVMI stage III or IV
6. Patients giving written consent to participate in the study
|
|
| ExclusionCriteria |
| Details |
1. Class II Div 2 Malocclusion
2. History of orthodontic treatment
3. Systemic diseases affecting bone metabolism
4. Patients with neuromuscular disorder & TMJ problems
5. Presence of any craniofacial anomalies or pathologies.
6. Presence of gross facial asymmetry.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correction of skeletal Class II malocclusion |
After completion of functional phase (Approximately 06 months) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the total treatment duration & frequency of appliance breakages. |
After completion of functional phase in approximately 06 months |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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 1 |
|
Date of First Enrollment (India)
|
20/04/2024 |
| 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="3"
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
|
Subjects found suitable in the above inclusion criteria for the study
shall be explained the scope of the study and written consent shall be
obtained. Pre-treatment records (T1) in the form of photographs (extraoral
& intraoral), radiographs i.e., OPG, Lateral cephalogram, and study models for maxillary and mandibular arch shall be recorded.
The patients will undergo the fixed
mechanotherapy with 0.022″ MBT PEA which will be started simultaneously with
functional jaw orthopedics. Two micro-implants will be inserted (one on either
side of the maxillary arch distal to maxillary canines), along with customized
anterior bite turbos made with a mini mold kit bonded on upper incisors. Intermaxillary
elastics will be used from lower molar hooks to the implants inserted in the maxillary
arch. The intermaxillary elastics will aid in the forward positioning of the mandibular
arch duly assisted by the anterior bite turbos. In addition, the bite turbos
will further aid in opening the deep bite.
Post-functional records (T2) in the form of photographs (extraoral &
intraoral), radiographs i.e., OPG, Lateral cephalogram, and dental models for maxillary and mandibular arch shall be obtained
after completion of Functional phase of the treatment. The treatment effects at
T1 and T2 will be evaluated and compared. |