| CTRI Number |
CTRI/2020/03/024087 [Registered on: 19/03/2020] Trial Registered Prospectively |
| Last Modified On: |
26/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
This study will help to see the effect of saliva on the coating of wire used in braces. |
|
Scientific Title of Study
|
Evaluation of the surface roughness and friction resistance of coated(esthetic) stainless steel orthodontic archwires. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pruthvi Mahajan |
| Designation |
Post Graduation student |
| Affiliation |
Manipal college of Dental sciences, Manipal |
| Address |
Room no 7,Departement of Orthodontics and dentofacial orthopedics, 2nd floor, Manipal college of dental sciences, MAHE, Manipal, Karantaka.
Udupi
KARNATAKA
576014
India |
| Phone |
8698583558 |
| Fax |
|
| Email |
pruthvi.mahajan0307@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhumitha Natarajan |
| Designation |
Associate Professor |
| Affiliation |
Manipal college of Dental sciences, Manipal |
| Address |
Room no 7,Departement of Orthodontics and dentofacial orthopedics, 2nd floor, Manipal college of dental sciences, MAHE, Manipal, Karantaka.
Udupi
KARNATAKA
576014
India |
| Phone |
9900834343 |
| Fax |
|
| Email |
madhumitha.natarajan@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Pruthvi Mahajan |
| Designation |
Post Graduation student |
| Affiliation |
Manipal college of Dental sciences, Manipal |
| Address |
Room no 7,Departement of Orthodontics and dentofacial orthopedics, 2nd floor, Manipal college of dental sciences, MAHE, Manipal, Karantaka.
KARNATAKA
576014
India |
| Phone |
8698583558 |
| Fax |
|
| Email |
pruthvi.mahajan0307@gmail.com |
|
|
Source of Monetary or Material Support
|
| Primary Investigator.
Dr. Pruthvi Mahajan
Room no 7, Department of Orthodontics and dentofacial orthopedics, 2nd floor, Manipal college of Dental sciences, Manipal, Karnataka-576104 |
|
|
Primary Sponsor
|
| Name |
Pruthvi Mahajan |
| Address |
Room no 7,Departement of Orthodontics and dentofacial orthopedics, 2nd floor, Manipal college of dental sciences, MAHE, Manipal, Karantaka. |
| Type of Sponsor |
Other [Primary Investigator] |
|
|
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 Pruthvi Mahajan |
Manipal college of dental sciences. |
Room no 7,Departement of Orthodontics and dentofacial orthopedics, 2nd floor, Manipal college of dental sciences, MAHE, Manipal, Karantaka.
Udupi
KARNATAKA |
8698583558
pruthvi.mahajan0307@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
patients needing orthodontic treatment. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Rhodium coated Archwires |
Dose:not applicable
Route of administration:Not applicable
Frequency: Fulltime wear(24hrs) for 21days.
Duration of Therapy: 21days |
| Comparator Agent |
Rhodium coated Archwires |
Not applicable as the wires used are directly recieved from the manufacturer. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
28.00 Year(s) |
| Gender |
Both |
| Details |
Orthodontic patients at end levelling and aligning |
|
| ExclusionCriteria |
| Details |
1)Patients not willing to participate.
2)Patients known allergic to Rhodium coated material component.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| At the end of the study we expect a decrease in Surface roughness and friction resistance of the wire. |
once after 21 days after placement of wire. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Since the wire used is coated with a material, the archwire can be used in patients for esthetics. |
once after 21 days of placement of wire. |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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)
|
25/03/2020 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The aim of this present study is to evaluate surface roughness and friction resistance of as received Rhodium coated stainless steel wires after oral exposure. The objective is To compare the surface roughness of coated stainless steel wire after oral exposure and To compare friction resistance of coated stainless wire after oral exposure. Inclusion criteria is orthodontic patients at end levelling and aligning and the Exclusion criteria: Patients not willing to participate. Patients known allergic to Rhodium coated material component.Preformed 0.019×0.025inch Rhodium coated stainless arch wires of maxillary and mandibular arch were inserted at T0 for each patient and retrieved after 21 days at T1 produces 4 sample per patient. All specimens were placed and removed from the mouth by the same operator and individually immersed in detergent in an ultrasound cleaner for a 20-minute cycle and afterwards in distilled water for an additional 10 minutes for disinfection and cleaning debris.The study period will be of 2 years with a sample size of 28. Primary outcome: At the end of the study we expect a decrease in Surface roughness and friction resistance of the wire. Secondary outcome: Since the wire used is coated with a material, the archwire can be used in patients for esthetics. |