| CTRI Number |
CTRI/2024/05/067763 [Registered on: 21/05/2024] Trial Registered Prospectively |
| Last Modified On: |
26/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Dental and bony changes in patients undergoing space closure of upper front teeth with and without anterior bite block |
|
Scientific Title of Study
|
Dental and skeletal changes in patients undergoing en-masse retraction with and without anterior bite turbo: A Randomized controlled 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 |
Dr Vinay Kumar Chugh |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Room number-210, OPD A block-2nd floor, Department of Dentistry,
Basni-2 AIIMS Jodhpur, Rajasthan-342005
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9413155103 |
| Fax |
|
| Email |
drvinaychd@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aswathy CA |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Room number-210, OPD A block-2nd floor, Department of Dentistry,
Basni-2 AIIMS Jodhpur, Rajasthan-342005
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8592915885 |
| Fax |
|
| Email |
aswathyjoan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aswathy CA |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Room number-210, OPD A block-2nd floor, Department of Dentistry,
Basni-2 AIIMS Jodhpur, Rajasthan-342005
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8592915885 |
| Fax |
|
| Email |
aswathyjoan@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Basni, Jodhpur, Rajasthan, India-342005 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Room number 210, OPD Block, 2nd floor, Department of Dentistry
Basni phase 2 AIIMS Jodhpur Jodhpur RAJASTHAN Jodhpur
RAJASTHAN 342005 India
Jodhpur
RAJASTHAN
342005
India |
| 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 ASWATHY CA |
AIIMS Jodhpur |
room no. 210, Department of dentistry,All India Institute of medical sciences, Basni, Jodhpur-342005
Jodhpur
RAJASTHAN |
8592915885
aswathyjoan@gmail.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, (2) ICD-10 Condition: M264||Malocclusion, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Anterior Bite turbo |
Retraction of maxillary anterior teeth WITH anterior bite turbo.
Anterior Bite turbos made of light-cured composite bonded in the lingual surface near cingulum region of maxillary anterior teeth using pre-formed molds. The anterior bite turbo placed during the retraction phase of maxillary anterior teeth which is about 8 to 12 months |
| Comparator Agent |
Without Bite Turbo |
Retraction of maxillary anterior teeth WITHOUT anterior bite turbo. Retraction phase of maxillary anteriors without anterior bite turbo is also about 8 to 12 months of duration. |
|
|
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.Full permanent dentition with sound first and second molars.3. Angle’s Class II division 1 malocclusion. 4. Requiring camouflage treatment by extraction of upper first premolars with overjet more than 6mm and overbite more than 3mm. 5. Patients with no or minimal crowding in maxillary arch (less than 3mm). 6. Good oral hygiene
|
|
| ExclusionCriteria |
| Details |
1. Patients with severe crowding in maxillary arch.
2. Patients with reduced overbite.
3. Patients requiring absolute anchorage where mini-implants may be desired.
4. Missing permanent teeth other than third molars.
5. Patients with any systemic disease or syndromes or any other craniofacial abnormalities.
6. Patient under medications that may affect orthodontic tooth movement. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the angular and linear changes in maxillary anterior teeth in patients undergoing en-masse retraction with or without anterior bite turbo |
T0-Before space closure
T1-After space closure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the angular and linear changes in mandibular incisors, maxillary first molar, sagittal and vertical skeletal parameters in patients undergoing en-masse retraction with or without anterior bite turbo |
T0-Before space closure
T1-After space closure |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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)
|
01/06/2024 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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 clinical trial, the changes on maxillary anterior teeth during
en-masse retraction will be compared in the patients with and without anterior
bite turbo. The outcome will be compared on the basis of movement of teeth in
anteroposterior and vertical dimension. Research
Question: What
are the effects on linear and angular changes of maxillary anterior teeth in
patients undergoing en-masse retraction with or without anterior bite turbo? Methods: Class
II division 1 malocclusion patients will be recruited from post-graduate
orthodontic clinic of Department of Dentistry. Patients
will be allocated into two groups: Group
I –Retraction with anterior bite turbo (Intervention group) Group
II – Retraction without anterior bite turbo (Control group) PRIMARY OUTCOME ·
To compare the angular and linear changes in
maxillary anterior teeth in patients undergoing en-masse retraction with or
without anterior bite turbo. SECONDARY OUTCOME ·
To compare the angular and linear changes
in mandibular incisors, maxillary first molar, sagittal and vertical skeletal
parameters in patients undergoing en-masse retraction with or without anterior bite
turbo.
Data
so obtained will be subjected to statistical evaluation. |