| CTRI Number |
CTRI/2024/11/076205 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
06/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Does oral mouth rinses alter the selected properties of arch wires used during clip treatment |
|
Scientific Title of Study
|
Evaluation Of The Effect Of Different Mouth Washes On The Selected Mechanical Properties And Surface Morphology Of Nickel Titanium (NiTi) Aligning Arch Wires - 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 |
FARZEEZFAREEN S |
| Designation |
Post Graduate Student |
| Affiliation |
Government Dental College And Hospital Cuddalore |
| Address |
Department Of Orthodontics And Dentofacial Orthopaedics
Government Dental College And Hospital Cuddalore
Erstwhile Rajah Muthiyah Dental College
Annamalai University
Chidambaram
Cuddalore
TAMIL NADU
608002
India |
| Phone |
9843899830 |
| Fax |
|
| Email |
farzeeorthodent@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
N Kurunji Kumaran |
| Designation |
Professor And Head |
| Affiliation |
Government Dental College And Hospital Cuddalore |
| Address |
Department Of Orthodontics And Dentofacial Orthopaedics
Government Dental College And Hospital Cuddalore
Erstwhile Rajah Muthiyah Dental College
Annamalai University
Chidambaram
Cuddalore
TAMIL NADU
608002
India |
| Phone |
9865835965 |
| Fax |
|
| Email |
drkurinchi@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
N Kurunji Kumaran |
| Designation |
Professor And Head |
| Affiliation |
Government Dental College And Hospital Cuddalore |
| Address |
Department Of Orthodontics And Dentofacial Orthopaedics
Government Dental College And Hospital Cuddalore
Erstwhile Rajah Muthiyah Dental College
Annamalai University
Chidambaram
Cuddalore
TAMIL NADU
608002
India |
| Phone |
9865835965 |
| Fax |
|
| Email |
drkurinchi@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College And Hospital Cuddalore
Erstwhile Rajah Muthiyah Dental College
Annamalai University
Chidambaram
Tamil Nadu
608002 |
|
|
Primary Sponsor
|
| Name |
FARZEEZFAREEN S |
| Address |
Government Dental College And Hospital Cuddalore
Erstwhile Rajah Muthiyah Dental College
Annamalai University
Chidambaram
Pincode 608002
|
| Type of Sponsor |
Other [Self Funding] |
|
|
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 FARZEEZ FAREEN S |
Government Dental College And Hospital |
Department Of Orthodontics And Dentofacial Orthopaedics
First floor
Cuddalore
TAMIL NADU |
09843899830
farzeeorthodent@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Medical College And Hospital Cuddalore District Erstwhile Rajah Muthiyah Medical College Institutional Human Ethics Committee |
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 |
| Comparator Agent |
Group A |
Wires that has not been used in patients (fresh wires as received from manufactures) |
| Intervention |
Group B |
Retrieved intraorally used wires that has been exposed to placebo mouth wash |
| Intervention |
Group C |
Retrieved intraorally used wires that has been exposed to 0.05% sodium fluoride mouth wash |
| Intervention |
Group D |
Retrieved intraorally used wires that has been exposed to 0.2% chlorhexidine mouth wash |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who are in need of Fixed Orthodontic Treatment
Subjects aged 15 to 35 years are included in this study
Both extractions and non extraction cases
Both males and females are included
|
|
| ExclusionCriteria |
| Details |
Subjects who has any visible sign of fluoros
Physically challenged patients those require assistance in oral care |
|
|
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 |
| Load deflection of NiTi |
8 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Elastic modulus and surface morphology of NiTi |
8 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
05/11/2024 |
| 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="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This study is a randomized, parallel group multiple arm trial ,this study evaluates the effect of different mouth washes on the selected mechanical properties and surface morphology of Nickel Titanium (NiTi) Aligning Arch Wires. The primary outcome of the study is to compare and evaluate the load deflection property of Nickel titanium (NiTi) aligning orthodontic arch wires when exposed to different mouthwashes for the period of 8 months. The secondary outcomes is to compare and evaluate the elastic modulus and surface morphology of Nickel titanium (NiTi) aligning orthodontic arch wires when exposed to different mouthwashes for the period of 8 months Total sample size was calculated to be 40. |