| CTRI Number |
CTRI/2024/05/067624 [Registered on: 20/05/2024] Trial Registered Prospectively |
| Last Modified On: |
11/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Changes in face profile and front upper teeth after removal of two upper back teeth during braces treatment |
|
Scientific Title of Study
|
Effect of maxillary first premolar extraction on soft tissue profile and incisor position in patients with Class ll division 2 malocclusion |
| 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 phase 2 AIIMS Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9413155103 |
| Fax |
|
| Email |
drvinaychd@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nisha Meena |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences Jodhpur |
| Address |
Room number-210, OPD block- 2nd floor, Department of Dentistry Basni phase 2 AIIMS Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8700022921 |
| Fax |
|
| Email |
meena000nisha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nisha Meena |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences Jodhpur |
| Address |
Room number-210, OPD block- 2nd floor, Department of Dentistry Basni phase 2 AIIMS Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8700022921 |
| Fax |
|
| Email |
meena000nisha@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Basni industrial area phase 2 AIIMS Jodhpur Rajasthan 342005 India |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Jodhpur |
| Address |
Basni industrial area phase 2 AIIMS Jodhpur Rajasthan 342005 Indis |
| 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 |
Room number-210, OPD block- 2nd floor, Department of Dentistry Basni phase 2 AIIMS Jodhpur Rajasthan
Jodhpur
RAJASTHAN |
9413155103
drvinaychd@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Jodhpur Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M263||Anomalies of tooth position of fully erupted tooth or teeth, (2) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, (3) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Class II Div 1 patients treated with extraction of maxillary first premolars will be selected as controls |
Class II Div 1 patients treated with extraction of maxillary first premolars will be selected as controls |
| Intervention |
Extraction of maxillary first premolars |
Patient will be called for separator placement, following which sequential banding and bonding of maxillary first molars will be done respectively. Bonding of maxillary arch with MBT prescription 0.022-inch slot brackets will be done. A transpalatal arch will be given on the palatal aspect for transverse control. Alignment and leveling will be done following extraction of maxillary first premolars. At the end of extraction space closure(T1), lateral cephalograms will be taken. Linear and angular changes will be measured on lateral cephalograms obtained before treatment (T0) and after space closure (T1). The total duration of the intervention will be approximately two years. Class II Div 1 patients treated with extraction of maxillary first premolars will be selected as controls. Data so obtained will be subjected to statistical evaluation.
|
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients older than 14 years to minimize the confounding factors of growth.
2.Patients with Angle’s Class II division 2 malocclusion.
3.Treatment involving camouflage with maxillary first premolar extraction.
4.Crowding more than or equal to 5 mm 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.
5.Patient under medications that may affect orthodontic tooth movement.
6.Patient requiring surgical orthodontic treatment for correction of malocclusion
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Soft tissue profile will be evaluated by comparing lateral cephalograms taken before treatment (T0) and after space closure (T1). |
T0- Before treatment
T1- After space closure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Linear and angular changes in maxillary incisors will be evaluated by comparing lateral cephalograms taken before treatment (T0) and after space closure (T1). |
T0- Before treatment
T1- After space closure |
|
|
Target Sample Size
|
Total Sample Size="29"
Sample Size from India="29"
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)
|
30/05/2024 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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 changes in the soft tissue profile and maxillary incisor position will be evaluated after extraction of maxillary first premolars and space closure in Class II division 2 patients treated with fixed orthodontic treatment. Class II Div 1 patients treated with extraction of maxillary
first premolars will be selected as controls.
Linear and angular changes will be measured on the lateral cephalograms obtained before treatment (T0) and after space closure (T1) using Dolphin imaging software. Data so obtained will be subjected to statistical evaluation. |