| CTRI Number |
CTRI/2025/01/079694 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Evaluation of root resorption using three different mechanics using CBCT scan taken before and after orthodonic treatment |
|
Scientific Title of Study
|
Comparative CBCT evaluation of root resorption in maxillary teeth following en masse retraction using Mini screws, Friction mechanics and Frictionless mechanics- 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 |
SHOBICA E |
| Designation |
Post Graduate Student |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
SRM Institute of Science and Technology,
Department of Orthodontics, SRM Dental College,
No. 30, Bharathi Salai, Ramapuram, Chennai
Chennai
TAMIL NADU
600089
India |
| Phone |
9445785510 |
| Fax |
|
| Email |
drshobiedwin@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SHOBICA E |
| Designation |
Post Graduate Student |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
SRM Institute of Science and Technology,
Department of Orthodontics, SRM Dental College,
No. 30, Bharathi Salai, Ramapuram, Chennai
Chennai
TAMIL NADU
600089
India |
| Phone |
9445785510 |
| Fax |
|
| Email |
drshobiedwin@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr N C Sushil Chakravarthi |
| Designation |
Reader |
| Affiliation |
SRM Institute of Science and technology,Ramapuram |
| Address |
SRM Institute of science and technology,
Department of orthodontics, SRM dental college,
No. 30, Bharathi Salai, Ramapuram, Chennai
Chennai
TAMIL NADU
600089
India |
| Phone |
9884273430 |
| Fax |
|
| Email |
sushilorthodontics@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Orthodontics,Second floor ,SRM Dental College,
No. 30, Bharathi Salai, Ramapuram, Chennai
Pincode -600089
Tamil Nadu,
India. |
|
|
Primary Sponsor
|
| Name |
SHOBICAE |
| Address |
SRM Institute of Science and Technology,
Department of Orthodontics, SRM Dental College,
No. 30, Bharathi Salai, Ramapuram, Chennai 600089, Tamil Nadu, India |
| Type of Sponsor |
Other [Self Sponsoring] |
|
|
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 SHOBICA E |
SRM Dental College |
SRM Institute of Science and Technology,
Department of Orthodontics, SRM Dental College,
No. 30, Bharathi Salai, Ramapuram, Chennai , Tamil Nadu, India
Chennai
TAMIL NADU |
09445785510
drshobiedwin@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRMDCIRB |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Friction mechanics-Soldered brass hooks with active tiebacks |
11 patients where Soldered brass hooks with active tiebacks will be used to compare the severity of root resorption with mini implants and frictionless mechanics group. |
| Intervention |
Frictionless mechanics-Tear drop loop |
Group II includes 11 patients where tear drop loops (frictionless mechanics) will be used for retraction.Limited field-of-view (FOV) CBCT scans will be taken at two intervals- before retraction (T0) and after retraction (T1).CS imaging software CS 9300® (Carestream Dental, Atlanta, GA, USA) with a current of 5 mA, voltage of 85 kV will be used. All CBCT images will be stored as DICOM files (Digital Imaging and Communications in Medicine) and then entered into Invivo™ 6 Software (Anatomage, San Jose, CA, USA). ). Severity of root resorption will be evaluated by measuring the 1.Root length 2.Axial dimension of the root (Mesio- distal width and labio lingual thickness) 3.Vertical alveolar bone level (VABL) |
| Intervention |
Mini implants |
Group I includes 11 patients where stainless steel mini-implants of dimensions 1.5mm×8 mm placed between second premolar and first molar as anchorage will be used for retraction.Limited field-of-view (FOV) CBCT scans will be taken at two intervals- before retraction (T0) and after retraction (T1).CS imaging software CS 9300® (Carestream Dental, Atlanta, GA, USA) with a current of 5 mA, voltage of 85 kV will be used. All CBCT images will be stored as DICOM files (Digital Imaging and Communications in Medicine) and then entered into Invivo™ 6 Software (Anatomage, San Jose, CA, USA). ). Severity of root resorption will be evaluated by measuring the 1.Root length 2.Axial dimension of the root (Mesio- distal width and labio lingual thickness) 3.Vertical alveolar bone level (VABL) |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with Class I bimaxillary protrusion 2.Patient who underwent all 1st premolars extraction
3. Patients between age 12 years and older 4.Patients with presence of all maxillary anteriors
|
|
| ExclusionCriteria |
| Details |
1.Patients who underwent previous orthodontic treatment
2.Patients with history of trauma in maxillary anteriors
3.Patients with compromised periodontal condition
4.Patients with endodontically treated and ankylosed teeth
5. Patients with systemic diseases
6.Patients with reported medical history of autoimmune diseases, arthritis, bone disease 7.Patients who are under medications that alter tooth movements
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Severity of root resorption in maxillary teeth following en masse retraction using Mini screws, Friction mechanics and Frictionless mechanics |
Before treatment and after 6 months of retraction |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Root length
2.Axial dimension of the root (Mesio- distal width and labio lingual thickness)
3.Vertical alveolar bone level (VABL)
|
Before treatment and after 6 months of retraction |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/02/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 is a randomized controlled trial evaluating the severity of root resorption in maxillary teeth following En masse retraction using Mini screws, Friction mechanics and Frictionless mechanics.3 group of patients will be included in the study .Prior to retraction CBCT will be taken .Patients in group 1 will undergo retraction using stainless steel mini implants placed between second premolar and first molar as anchorage .Patients in group 2 will undergo retraction using soldered brass hooks with active tie backs . Patients in group 3 will undergo retraction using tear drop loops .Post op CBCT will be taken after retraction in all the 3 groups. Primary outcome is to evaluate the severity of root resorption in maxillary teeth following en masse retraction . Secondary outcomes include Root length ,Axial dimension of the root and Vertical alveolar bone level . |