| CTRI Number |
CTRI/2020/04/024709 [Registered on: 17/04/2020] Trial Registered Prospectively |
| Last Modified On: |
09/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A COMPARATIVE EVALUATION OF PROPERTIES OF TWO DIFFERENT WIRES |
|
Scientific Title of Study
|
A COMPARATIVE EVALUATION OF FRICTIONAL CHARACTERISTICS OF TWO ARCHWIRE MATERIALS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SNEHA R ISMAIL |
| Designation |
MDS STUDENT |
| Affiliation |
PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH |
| Address |
SIBI COTTAGE, GRA G 15, GANDHIPURAM ROAD, SREEKARIYAM PO, TRIVANDRUM 695017
PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH, VENKODE, VATTAPPARA, TRIVANDRUM
Thiruvananthapuram
KERALA
695017
India |
| Phone |
8289897869 |
| Fax |
|
| Email |
sneharemmy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhav Manoj |
| Designation |
Professor |
| Affiliation |
PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH |
| Address |
Smile Avenue Charachira plamood Trivandrum
PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH VENKODE VATTAPPARA TRIVANDRUM
Thiruvananthapuram
KERALA
695004
India |
| Phone |
9847318768 |
| Fax |
|
| Email |
madhavmanoj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SNEHA R ISMAIL |
| Designation |
MDS STUDENT |
| Affiliation |
PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH |
| Address |
SIBI COTTAGE, GRA G 15, GANDHIPURAM ROAD, SREEKARIYAM PO, TRIVANDRUM 695017
PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH, VENKODE, VATTAPPARA, TRIVANDRUM
Thiruvananthapuram
KERALA
695017
India |
| Phone |
8289897869 |
| Fax |
|
| Email |
sneharemmy@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SNEHA R ISMAIL |
| Address |
PMS COLLLEGE OF DENTAL SCIENCE AND RESEARCH, GOLDEN HILLS, VENKODE, VATTAPPARA, TRIVANDRUM |
| 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 |
| SNEHA R ISMAIL |
PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH |
PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH, VENKODE, VATTAPPARA, TRIVANDRUM
Thiruvananthapuram
KERALA |
8289897869
sneharemmy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUITIONAL ETHICS COMMITEE, PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH, VATTAPPARA, TRIVANDRUM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Copper nickel titanium archwire |
Used for initial alignment of arches for 6-8 months |
| Intervention |
Titanium niobium tantalum zirconium archwire |
Used for initial alignment of arches for 6-8 months |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
20.00 Year(s) |
| Gender |
Both |
| Details |
Littles irregularity index 2-4 mm
Patients with no history of orthodontic treatment
Confirmation that all permanent teeth were fully erupted from 2nd molar to 2nd molar
No history of trauma to periodontium |
|
| ExclusionCriteria |
| Details |
Known allergy to nickel or to any other metal
History of long term drug uses
History of any systemic diseases
Abnormal chewing habits
Patients with proximal caries or restorations |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There will be difference in mechanical parameters between two archwire wires in as received state |
6 months (24 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| There will be difference in mechanical parameters between two archwire soldiers after initial alignment |
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 1 |
|
Date of First Enrollment (India)
|
06/07/2020 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
During orthodontic treatment, friction in the bracket - archwire interface plays an important role in the rate of orthodontic tooth movement as; a decrease in friction might shorten the treatment duration and improve anchorage control. The factors responsible for friction between bracket - arch wire interface include; archwire materials, environment (wet or dry), and surface roughness. The proper understanding of arch wire behaviour in clinical scenario will help in appropriate selection of arch wire in orthodontic mechanotherapy. AIMS The aim of this research is to compare and characterize two orthodontic archwire alloys, Copper Nickel-Titanium (CuNiTi) and Titanium-Niobium-Tantalum-Zirconium (Ti-Nb-Ta-Zr) based on the mechanical parameters namely, frictional resistance, surface characteristics and elemental analysis. These mentioned parameters are evaluated, both before employing the arch-wire for initial alignment and after the initial alignment. MATERIALS AND METHODS
40 specimens each of CuNiTi and Gummetal (Ti-Nb-Ta-Zr) wires are to be used in this study.Testing specimens include archwires of 0.016 inch round CuNiTi archwires and 0.016inch Ti-Nb-Ta-Zr archwires.The study is planned to be carried out through two stages.40 subjects with Irregularity Index of Mild level (Scores 1-3) and Moderate level (Scores 4-6) are selected. Subjects will be randomly selected into two groups for initial alignment with CuNiTi archwire and Ti-Nb-Ta-Zr archwire. Each group comprises of 20 subjects. The1st stage of the study is conducted on the archwire specimens in the “as received†state. The wires are mechanically evaluated for frictional resistance by an Instron Universal Testing Machine. The surface characteristics are evaluated by scanning electron microscope and elemental analysis by X-Ray Fluorescence (XRF). The obtained parameter values will be documented. The remaining 20 archwire specimens each of NiTi and Gummetal wires are then employed for initial alignment in the subjects selected for study. After the initial alignment phase, the archwires are removed and disinfected with 2% glutaraldehyde solution. The archwires are then mechanically evaluated and the parameter values will be duly documented. The obtained values are then comparatively evaluated and statistically analysed. |