| CTRI Number |
CTRI/2025/04/084765 [Registered on: 15/04/2025] Trial Registered Prospectively |
| Last Modified On: |
01/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
ASSESSMENT OF POST TREATMENT STABLITY IN NON-EXRACTION CASES TREATED WITH MBT SYSTEM VERSUS PASSIVE SELF LIGATING SYSTEM |
|
Scientific Title of Study
|
EVALUATION OF POST TREATMENT STABLITY WITH MBT SYSTEM VERSUS PASSIVE SELF LIGATING SYSTEM IN NON-EXTRACTION CASES: ANALYTICAL OBSERVATIONAL STUDY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anusha P G |
| Designation |
Post graduate |
| Affiliation |
Government dental college and research institute |
| Address |
Government dental college and research institute, new tharagurpet, Victoria hospital campus, kalasipalya , bangalore 560002
Bangalore
KARNATAKA
562157
India |
| Phone |
09902408700 |
| Fax |
|
| Email |
anubds04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RAJALAKSHMI S J |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Government dental college and research institute |
| Address |
Government dental college and research institute, new tharagurpet, Victoria hospital campus, kalasipalya , bangalore 560002
Bangalore
KARNATAKA
562157
India |
| Phone |
9844137499 |
| Fax |
|
| Email |
rajalakshmisj19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anusha P G |
| Designation |
Post graduate |
| Affiliation |
Government dental college and research institute |
| Address |
Government dental college and research institute, new tharagurpet, Victoria hospital campus, kalasipalya , bangalore 560002
Bangalore
KARNATAKA
562157
India |
| Phone |
09902408700 |
| Fax |
|
| Email |
anubds04@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT DENTAL COLLEGE AND RESEARCH INSTITUTE, VICTORIA HOSPITAL CAMPUS, NEAR CITY MARKET, KALASIPALYA, BANGALORE
KARNATAKA, INDIA 560002 |
|
|
Primary Sponsor
|
| Name |
Anusha P G |
| Address |
GOVERNMENT DENTAL COLLEGE AND RESERCH INSTITUTE, VICTORIA HOSPITAL CAPMUS, NEAR CITY MARKET, KALASIPALYA BANGALORE, KARNATAKA, INDIA 560002 |
| Type of Sponsor |
Other [self] |
|
|
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 ANUSHA P G |
GOVERNMENT DENTAL COLLEGE AND RESERCH INSTITUTE |
ROOM NO 06, DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPEDICS, GDCRI, VICTORIA HOSPITAL CAMPUS, NEAR KR MARKET, KALASIPALYA 560002
Bangalore
KARNATAKA |
9902408700
anubds04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE, GOVERNMENT DENTAL COLLEGE RESEARCH INSTITUTE, BANGALORE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Malocclusion patients treated with MBT system or Passive self-ligating system with non-extraction treatment plan |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
SUBJECTS TREATED WITH MBT SYSTEM, SUBJECTS TREATED WITH PASSIVE SELF-LIGATING, NON-EXTRACTION CASES, SUBJECTS WILLING TO USE ESSIX RETAINER IN THE MAXILLARY ARCH, SUBJECTS WILLING TO USE FIXED LINGUAL RETAINER IN MANDIBULAR ARCH, SUBJECTS WITH MODERATE CROWDING, SUBJECTS WITH FULL COMPLEMENT OF PERMANAENT TEETH |
|
| ExclusionCriteria |
| Details |
MISSING OR SUPERNUMERARY TEETH AND PROSTHETIC RESTORATION, SYSTEMIC DISEASE, SYNDROMES OR SKELETAL DYSGNATHIA WHICH REQUIRES SURGICAL INTREVENTION, SUBJECTS WITH POOR COMPLIANCE OR ORAL HYGIENE WHICH HAVE LED TO EARLY TREMINATION OF FIXED ORTHDONTICS TREATMENT, ANTERIOR CROSSBITE, SUBJECTS WITH PREVIOUS HISTORY OF ORTHDONTIC TREATMENT |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe changes in relation to intermolar width, intercanine width, arch length, overjet and overbite will be measured with MBT system and passive self-ligating system |
Immediately after debonding and followed up for one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the differences between intermolar width, intercanine width, arch length, overjet & overbite will be measured between MBT system & passive self-ligating system |
will be measured immediately after debonding & followed uo for one year |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Stability in post treatment remains major issue in orthodontics. Maintenance of arch form, arch width during active treatment plays an important role in post treatment stability. Richard McLauglin, Bennett, Trivisi have developed third generation bracket system known as MBT prescription with an in-built tip and torque. This bracket system uses light, continuous force, lace backs and bend backs. The MBT system has no compromise in ideal static occlusion because measurement is based on Andrews original research. Passive self -ligating system includes Broad arch wires and self-ligating brackets with passive slide on the outward face of bracket and have less friction during sliding mechanism than MBT system counterparts. Passive self -ligating system claims to resolve dental arch deficiency by providing stable posterior arch expansion. Studies states that in non-extraction cases treated with either passive self-ligating system or MBT system reported no differences between two groups for any maxillary transvers dimensional variables. A successful orthodontic treatment depends upon post treatment stability. Hence, present study aims at prospective stability of both maxillary and mandibular arches treated with MBT system and passive self -ligating system in non- extraction cases. |