| CTRI Number |
CTRI/2024/04/065653 [Registered on: 15/04/2024] Trial Registered Prospectively |
| Last Modified On: |
03/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the performance of two types of braces on the same person. |
|
Scientific Title of Study
|
Comparison of the efficacy of alignment using self-ligating brackets (SLB) and conventional MBT brackets - A SPLIT MOUTH STUDY. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
M Keerthana |
| Designation |
Junior resident |
| Affiliation |
Government dental college Kottayam |
| Address |
Government dental college Kottayam
Department of orthodontics
B-block Room no 304
Gandhinagar P.O
Kottayam
Kerala
Government dental college Kottayam
Department of orthodontics
B-block Room no 304
Gandhinagar P.O
Kottayam
Kerala
Kottayam
KERALA
686008
India |
| Phone |
9498059464 |
| Fax |
|
| Email |
keerthana.mvk491@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
G Sreejithkumar |
| Designation |
Professor and Head of the orthodontic and dentofacial orthopaedic department |
| Affiliation |
Government dental college Kottayam |
| Address |
Government dental college Kottayam
Department of orthodontics and dentofacial orthopaedics
B block Room no 304
Gandhinagar P.O
Kottayam
Kerala
Government dental college Kottayam
Department of orthodontics and dentofacial orthopaedics
B block Room no 304
Gandhinagar P.O
Kottayam
Kerala
Kottayam
KERALA
686008
India |
| Phone |
9447188448 |
| Fax |
|
| Email |
drsreejithkumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
M Keerthana |
| Designation |
Junior resident |
| Affiliation |
Government dental college Kottayam |
| Address |
Government dental college Kottayam
B block Room no 304
Gandhinagar P.O
Kottayam
Kerala
Kottayam
KERALA
686008
India |
| Phone |
9498059464 |
| Fax |
|
| Email |
keerthana.mvk491@gmail.com |
|
|
Source of Monetary or Material Support
|
| M Keerthana
Department of orthodontics
Government dental college Kottayam
B block Room no 304
Gandhinagar P.O
Kottayam
Kerala 686008
India
|
|
|
Primary Sponsor
|
| Name |
M Keerthana |
| Address |
Government dental college Kottayam
Department of orthodontics
B block Room no 304
Gandhinagar P.O
Kottayam
Kerala
686008
|
| Type of Sponsor |
Other [Self ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| Nil |
Nil |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| M Keerthana |
Government dental college Kottayam |
Government dental college Kottayam
Department of orthodontics and dentofacial orthopaedics
B block Room no 304
Gandhinagar P.O
Kottayam
Kerala
686008
Kottayam
KERALA |
9498059464
keerthana.mvk491@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) Government dental college kottayam |
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 |
Conventional MBT brackets |
MBT preadjusted brackets were bonded to contralateral quadrant of the either arch at the same visit. A 0.016-inch Cu NiTi wire were used for alignment in both the groups for the period of six months. |
| Intervention |
Self ligating brackets (SLB) |
Self-ligating brackets were bonded to one quadrant of the either arch (right or left). A 0.016-inch Cu NiTi wire were used for alignment for the period of six months.
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
20.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects in permanent dentition between the age group of 12-20 years both male and
female.
2. Arch length – tooth size discrepancy in the range of 5-10mm in Lower arch.
3. Cases requiring first premolar extraction in mandibular arch on both sides as part of
fixed appliance therapy.
4. Subjects with no active local (oral) or systemic diseases.
5. Subjects with good oral and general health. |
|
| ExclusionCriteria |
| Details |
1. Subjects with previous history of extraction or orthodontic treatment.
2. Periodontally compromised teeth.
3. Poor oral hygiene.
4. Subjects hesitant to give consent to participate in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess alignment efficacy during initial stage of fixed appliance therapy |
The duration of the study is 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| (Same as primary outcome) To assess alignment efficacy during initial stage of fixed appliance therapy |
The duration of the study is 6 months |
|
|
Target Sample Size
|
Total Sample Size="11"
Sample Size from India="11"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
29/04/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The plaster models of either arches of the subjects were blindly coded for de-identification process, scanned using a 3D laser scanner and then rendered into a 3D stereolitographic digital model through specific software (3 Shape ortho analyser software or CAD-CAM). Little’s index irregularity (LII) digital measurements will be taken prior to treatment (T0). Self-ligating brackets were bonded to one quadrant of the either arches (right or left) and MBT preadjusted brackets were bonded to contralateral quadrant of the either arches at the same visit. A 0.016-inch Cu NiTi wire were used for alignment in both the groups for the period of six months. The conventional MBT brackets were fully ligated using elastomeric ligatures. No auxiliaries, such as lingual arches, bite plates or intermaxillary elastics will be used during the study period. After the period of 6 months, little’s irregularity index (LII) digital measurements will be repeated for post intervention assessment(T1) and calculation will be done for comparison of outcomes.
|