| CTRI Number |
CTRI/2025/10/096265 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
17/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To check root length and bone changes in upper front teeth after treatment in patients having forwardly placed upper front teeth. |
|
Scientific Title of Study
|
Evaluation of apical root resorption and alveolar bone changes in maxillary anteriors after space closure in patients treated with modified intrusion and retraction mechanics |
| 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 |
drvinaychd@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 |
drvinaychd@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shaker Singh Bisht |
| 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 |
09958601991 |
| Fax |
|
| Email |
drshakerbisht@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Jodhpur |
| Address |
AIIMS Jodhpur,Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Basni, Jodhpur, Rajasthan 342005 |
| Type of Sponsor |
Research institution and hospital |
|
|
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
RAJASTHAN
Jodhpur
RAJASTHAN |
003996704
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: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Modified intrusion and
retraction mechanics |
Root resorption in maxillary anterior teeth measured in terms of changes in root
length, root volume and change in alveolar bone height and thickness in Patients with Class II Division 1 malocclusion treated with En-masse retraction of maxillary anterior teeth with modified intrusion and
retraction mechanics. Rectangular 0.019 x 0.025 inch-stainless steel archwire will be taken as base archwire. On the base arch wire hooks with distal extension will be soldered between lateral incisor and canine
bracket.Intrusion springs will be inserted in the
auxillary slot of first molar tube allowing free sliding over the distal extension of the soldered hooks. Space closure will be done using elastomeric chain. Changes in the patient will be accessed before start of space closure (Pre-retraction-T0) and after space closure (post-retraction -T1) using CBCT. The time for space closure varies from 8 to 14 months. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients belonging to the age group of 16 to 35 years belonging to both sexes.
2 Patients with Angle’s Class II Division 1 malocclusion.
3 Patients requiring camouflage treatment by extraction of upper first premolars.
4 Overjet greater than 5mm and overbite 0 to 4 mm.
5 Average growth pattern Frankfort mandibular plane angle 22 to 28 degrees with standard deviation of 3 degree
6 Patients with no or minimal crowding in maxillary arch less than 3mm.
7 Patients requiring maximum anchorage during space closure.
8 Fully erupted permanent dentition except third molar.
9 Good oral hygiene. |
|
| ExclusionCriteria |
| Details |
1 Patients with severe crowding in maxillary arch.
2 Patients requiring absolute anchorage where mini-implants may be desired.
3 Missing permanent teeth other than third molars.
4 Patients with any systemic disease or syndromes or any other craniofacial abnormalities.
5 Patient under medications that may affect orthodontic tooth movement. |
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the external apical root resorption in the maxillary anterior teeth using cone
beam computed tomography taken pre (T0) and at the end of the space closure (T1) with
modified intrusion and retraction mechanics. |
Pre Retraction (T0)(Before space closure - 0 months )
Post Retraction (T1)( After space closure- 12 months) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate change in buccal & palatal crestal bone height after completion of
retraction.
To evaluate change in buccal & palatal alveolar bone thickness of the maxillary anterior teeth after
completion of retraction. |
Pre Retraction (T0)(Before space closure -0 months)
Post Retraction (T1)(After space closure- 12 months). |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
28/10/2025 |
| 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
|
In this prospective study, the external apical root resorption and alveolar bone remodelling in the maxillary anterior teeth will be evaluated after en-masse retraction of maxillary anterior teeth with modified intrusion and retraction mechanics in fixed orthodontic patients. The outcomes will be evaluated based on linear along with volumetric changes in the root and changes in height and thickness of the alveolar bone. Population- Patients with Class II Division 1 malocclusion Intervention – En-masse retraction of maxillary anterior teeth with modified intrusion and retraction mechanics Comparator – Same group after retraction Outcomes - Root resorption in maxillary anterior teeth measured in terms of changes in root length, root volume and change in alveolar bone height and thickness. Time period- 24 months |