| CTRI Number |
CTRI/2024/04/066072 [Registered on: 22/04/2024] Trial Registered Prospectively |
| Last Modified On: |
09/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Analysing how well the BRIUS® appliance works compared to traditional Labial and Lingual braces – using computer modeling and real-world testing to see which one is better. |
|
Scientific Title of Study
|
Analysing the Efficacy of BRIUS® Appliance in comparison to Conventional Labial and Lingual Appliance – A Finite Element Analysis and Clinical Validation |
| 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 Shakfi Rahman |
| Designation |
Post graduate student |
| Affiliation |
Manav Rachna Dental College |
| Address |
Manav Rachna Dental College School of Dental Science MRIIRS Department no 3 Ground floor Surajkund Road Faridabad Haryana 121003 India
Faridabad
HARYANA
121003
India |
| Phone |
7992396554 |
| Fax |
|
| Email |
shakfirahman786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Puneet Batra |
| Designation |
Principal (Prof) HOD |
| Affiliation |
Manav Rachna Dental College |
| Address |
Manav Rachna Dental College School of Dental Science MRIIRS Department no 3 Ground floor Surajkund Road Faridabad Haryana 121003 India
Faridabad
HARYANA
121003
India |
| Phone |
9810335961 |
| Fax |
|
| Email |
drpuneetbatra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhita Malhotra |
| Designation |
Reader |
| Affiliation |
Manav Rachna Dental College |
| Address |
Manav Rachna Dental College School of Dental Science MRIIRS Department no 3 Ground floor Surajkund Road Faridabad Haryana 121003 India
Faridabad
HARYANA
121003
India |
| Phone |
9310761506 |
| Fax |
|
| Email |
abhita2387@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Manav Rachna Dental College School of Dental Science MRIIRS Department no 3 Ground floor Surajkund Road Faridabad Haryana |
|
|
Primary Sponsor
|
| Name |
Dr Shakfi Rahman |
| Address |
Manav Rachna Dental College School of Dental Science MRIIRS Department no 3 Ground floor Surajkund Road Faridabad Haryana |
| Type of Sponsor |
Other [self funded] |
|
|
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 Shakfi Rahman |
Manav Rachna Dental College |
Manav Rachna Dental College School of Dental Science MRIIRS Department no 3 Ground floor Surajkund Road Faridabad Haryana 121003 India
Faridabad
HARYANA |
7992396554
shakfirahman786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Manav Rachna Institutional Ethics Committe |
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 |
BRIUS® |
Finite element analysis will be done to assess the biomechanical efficiency of the appliance and dental, dentoalveolar and soft tissue changes will be assessed clinically
since it is an orthodontic treatment duration of therapy intervention will be 2years |
| Comparator Agent |
conventional Labial appliance |
The dental, dentoalveolar and soft tissue changes will be assessed
since it is an orthodontic treatment duration of therapy intervention will be 2years |
| Comparator Agent |
conventional Lingual appliance |
The dental, dentoalveolar and soft tissue changes will be assessed
since it is an orthodontic treatment duration of therapy intervention will be 2years |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Class I bimaxillary protrusion cases requiring 1st premolar extraction with mild crowding cases (less than 5mm)
Good gingival and periodontal health status
|
|
| ExclusionCriteria |
| Details |
Periodontally compromised patient
Craniofacial disorder
Patient with any systemic disease
Moderate to severe crowding (more than 5mm) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess biomechanical efficiency of BRIUS® using FEM analysis in Class I bimaxillary protrusion cases, requiring all 1st premolar extractions |
TO-Before treatment
T1-After treatment
(12-18months) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess biomechanical efficiency of BRIUS® using FEM analysis in Class I bimaxillary protrusion cases, requiring all 1st premolar extractions |
TO-Before treatment
T1-After treatment
(12-18months) |
| To assess the clinical changes in dental and dentoalveolar parameters with BRIUS® appliance when compared to the conventional Labial and Lingual appliance in Class I bimaxillary protrusion cases, requiring all 1st premolar extractions |
TO-Before treatment
T1-After treatment
(12-18months) |
| To assess the soft tissue changes with BRIUS® appliance when compared to the Conventional Labial and Lingual appliance in Class I bimaxillary protrusion cases, requiring all 1st premolar extractions |
TO-Before treatment
T1-After treatment
(12-18months) |
| To assess patient compliance |
Mid treatment |
|
|
Target Sample Size
|
Total Sample Size="21"
Sample Size from India="21"
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)
|
30/04/2024 |
| 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="1"
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
|
In this study Finite Element Model Analysis will be done on BRIUS Appliance to assess the biomechanical efficiency of the appliance and the dental, dentoalveolar and soft tissue changes seen in the treatment with BRIUS appliance will be compared with that of the conventional labial and lingual appliance in patient with Class I bimaxillary protrusion with crowding less than 5 mm. |