| CTRI Number |
CTRI/2025/01/079221 [Registered on: 22/01/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To check changes in root and bone around upper front teeth after removal of two upper back teeth during braces treatment |
|
Scientific Title of Study
|
Evaluation of root resorption and changes in the alveolar bone in maxillary incisors in Class II Divison 2 patients requiring first premolar extraction |
| 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 Vinay Kumar Chugh |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Room number - 210, OPD block - 2nd floor, Department of Dentistry, Basni- 2, AIIMS Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003996704 |
| Fax |
|
| Email |
dyvinaychd@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinay Kumar Chugh |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Room number - 210, OPD block - 2nd floor, Department of Dentistry, Basni- 2, AIIMS Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003996704 |
| Fax |
|
| Email |
dyvinaychd@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devika Varshini M |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Room number - 210, OPD block - 2nd floor, Department of Dentistry, Basni- 2, AIIMS Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9585682797 |
| Fax |
|
| Email |
devikavarshini1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Jodhpur,Basni Industrial Area 2, Rajasthan |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Jodhpur |
| Address |
All INDIA INSTITUTE OF MEDICAL SCIENCES, Basni Industrial Area 2, Rajasthan Jodhpur 342005 |
| Type of Sponsor |
Government 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 |
| Dr Vinay Kumar Chugh |
All India Institute of Medical Sciences |
Department of Dentistry, A block 210, All India Institute of Medical Sciences Jodhpur
Jodhpur
RAJASTHAN |
8003996704
drvinaychd@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, All India Institute of Medical Sciences, Jodhpur |
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 |
| Comparator Agent |
Extraction |
Extraction of maxillary first premolar in patients with Class II Division 1 malocclusion with total duration of 2 years |
| Intervention |
Extraction |
Extraction of maxillary first premolar in patients with Class II Division 2 malocclusion with total duration of 2 years |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients belonging to age group greater than or equal to 14 years to minimize the confounding factors of growth.
2. Patients with Class II Division 2 malocclusion.
3. Treatment involving camouflage of skeletal malocclusion with maxillary first premolar extraction.
4. Crowding greater than or equal to 7mm in maxillary arch
5. Overbite more than 60%
6. Fully erupted permanent dentition except third molar.
7. Good oral hygiene. |
|
| ExclusionCriteria |
| Details |
1. Missing permanent teeth other than third molars.
2. Patient with minimal crowding.
3. History of previous orthodontic treatment
4. Patients with any systemic disease or syndromes or any other craniofacial abnormalities.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the apical root resorption in the maxillary incisors using Cone Beam Computed Tomography taken pre (T0) and post space closure (T1) in treatment and control groups. |
Pre space closure (T0)
Post space closure (T1) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate buccal & palatal crestal bone height in maxillary incisors.
To evaluate buccal & palatal alveolar bone thickness at 3mm, 6mm & 9mm from cementoenamel junction CEJ of the maxillary incisors.
|
Pre space closure T0
Post space closure T1 |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
03/02/2025 |
| 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="2"
Months="0"
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
|
Studies have been conducted which have evaluated root resorption and alveolar bone remodelling changes in two-dimensional radiographs like lateral cephalograms, orthopantomograms and intra-oral periapical radiographs. However, 3D assessment is needed to quantitatively measure detailed volumetric information about EARR and alveolar bone. Also, literature comparing the changes in root and alveolar bone dimensions in Class II Division 1 and Class II Division 2 patients are deficient. Thus, the present study aims to prospectively evaluate and compare root resorption and alveolar bone changes in the maxillary anterior region in Class II Division 1 and Class II Division 2 patients. |