CTRI Number |
CTRI/2024/04/066050 [Registered on: 22/04/2024] Trial Registered Prospectively |
Last Modified On: |
19/04/2024 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Other |
Public Title of Study
|
AN EVALUATION AND COMPARISION OF FRICTIONAL RESISTANCE, SURFACE ROUGHNESS AND MICROBIAL COLONIZATION OF SILVER COATED AND UNCOATED STAINLESS STEEL ARCHWIRES – AN IN VIVO STUDY |
Scientific Title of Study
|
AN EVALUATION AND COMPARISION OF FRICTIONAL RESISTANCE, SURFACE ROUGHNESS AND MICROBIAL COLONIZATION OF SILVER COATED AND UNCOATED STAINLESS STEEL ARCHWIRES – AN IN VIVO STUDY |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Rutvi Raval |
Designation |
2nd year PG student |
Affiliation |
Manubhai Patel Dental Hospital |
Address |
Department of Orthodontics and Dentofacial Orthopedics Manubhai Patel Dental Hospital MunjMahuda Vadodara Gujarat Vishwajyoti Ashram
Near Vidyakunj School MunjMahuda Vadodara Gujarat
390011
Vadodara GUJARAT 390011 India |
Phone |
9409400440 |
Fax |
|
Email |
rutvi.vr@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Padmaja Arora |
Designation |
Professor |
Affiliation |
Manubhai Patel Dental Hospital |
Address |
Department of Orthodontics and Dentofacial Orthopaedics,
Manubhai Patel Dental Hospital Vishwajyoti Ashram
Near Vidyakunj School MunjMahuda Vadodara Gujarat 390011
Vadodara
GUJARAT
390011
India
Vadodara GUJARAT 390011 India |
Phone |
9033975429 |
Fax |
|
Email |
padmaja2216@yahoo.co.in |
|
Details of Contact Person Public Query
|
Name |
Dr Padmaja Arora |
Designation |
Professor |
Affiliation |
Manubhai Patel Dental Hospital |
Address |
Department of Orthodontics and Dentofacial Orthopaedics,
Manubhai Patel Dental Hospital Vishwajyoti Ashram
Near Vidyakunj School MunjMahuda Vadodara Gujarat 390011
Vadodara
GUJARAT
390011
India
Vadodara GUJARAT 390011 India |
Phone |
9033975429 |
Fax |
|
Email |
padmaja2216@yahoo.co.in |
|
Source of Monetary or Material Support
|
Manubhai Patel Dental Hospital & ORI, Vadodara, Gujarat, India - 390011 |
|
Primary Sponsor
|
Name |
Dr Rutvi Raval |
Address |
56, Spun Ville
lane 4 arunoday soc
Alkapuri Vadodara - 390007 |
Type of Sponsor |
Other [self sponsored] |
|
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 Rutvi Raval |
Manubhai Patel Dental Hospital |
Department of Orthodontics and Dentofacial Orthopaedics
Vishwajyoti Ashram, Nr. Vishwamitri Bridge, Munj Mahuda, Vadodara - 390011 Vadodara GUJARAT |
9409400440
rutvi.vr@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
MAHARAJA KRISHNAKUMAR SINHJI BHAVNAGAR UNIVERSITY ETHICS COMMITTEE FOR MDS COURSE AND DENTAL RESEARCH |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K056||Periodontal disease, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
silver nanoparticles coated archwire |
surface coating of silver nanoparticles on stainless steel archwire and placing it in patients for 6 weeks |
Comparator Agent |
uncoated stainless steel archwire |
no coating done on stainless steel archwire and placed in patients for 6 weeks |
|
Inclusion Criteria
|
Age From |
14.00 Year(s) |
Age To |
40.00 Year(s) |
Gender |
Both |
Details |
i.Patients requiring therapeutic extraction of bilateral upper first premolars as a part of the treatment.
Good oral hygiene and healthy periodontium |
|
ExclusionCriteria |
Details |
i.Patients who do not give consent for the study
ii.Poor oral hygiene
iii.Patients with compromised periodontium
iv.Non extraction cases
v.Systemic illnesses like Diabetes mellites, AIDS, patients on medication like phenytoin, or immunosuppressants.
vi.Missing teeth in the anterior region |
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
evaluate and compare frictional resistance of a silver coated and uncoated stainless steel wire |
6 weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
evaluate & compare surface roughness of a silver coated & uncoated stainless steel wire |
6 weeks |
evaluate & compare microbial colonization of a silver coated & uncoated of stainless steel archwire |
6 weeks |
|
Target Sample Size
|
Total Sample Size="31" Sample Size from India="31"
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/ Phase 2 |
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="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Data are available indefinitely at (Link to be included rutvi.vr@gmail.com).
- For how long will this data be available start date provided 30-04-2024 and end date provided 18-04-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
|
This will be a split mouth in-vivo study. 31 patients undergoing orthodontic treatment will be selected for the study. The maxillary teeth will be well aligned, requiring extraction of 1st premolar as a part of treatment. Each participant will be treated with fixed pre-adjusted appliance. The system used will be metal 0.022 x 0.028†slot MBT bracket system. Surface Modification: The surface modification of wires to be coated with silver ions will be carried out by the thermal vacuum evaporation method with silver (10nm size) using vacuum coating unit model no.- 15 F6 HINDHIVAC (Hind High Vacuum Co., Bangalore). This instrument produces thin, homogenous, uniform, pure film coatings of the metal. Pure silver (99.9%) will be used to obtain thin coating on orthodontic wires. The thickness will be kept constant at 10nm for all depositions and it will be measured in situ using a quartz crystal thickness monitor. The argon (Ar) gas will be used as a sputtering gas (7sccm), whose flow will be controlled by the mass flow controller (MFC, AALBORG, Germany). Direct current (DC) sputtering is a thin film PVD-coating technique where a target material to be used as a coating is bombarded with ionized gas molecules causing atoms to be “sputtered†off into the plasma. These vaporized atoms are then deposited when they condense as a thin film on the substrate to be coated. In this study, 40 W DC sputtering power and 10 milli torrent (m Torr) pressure will be used. Also, the thickness of silver nanoparticle film is kept 10nm to avoid any significant alteration in its dimension.
Allocation Method: : Participants will be allocated into 2 sides; the right side of the patient will be the silver coated side of the archwire and left be the uncoated side of the archwire. Control side will be the uncoated side of the archwire. Experimental side will be the silver coated side of the archwire.
The patients will start undergoing treatment with fixed appliances. The upper arch will be bonded with 0.022 x 0.028†slot MBT bracket system. Before commencing the study, the patients will be treated with a wire sequence of 0.012†NiTi, 0.016†NiTi, 0.018†NiTi, 0.017 x 0.025†NiTi, as required of the case. Patients will then be given 0.019†x 0.025†stainless steel (half coated) wire for 6 weeks for torque expression. Castroviejo caliper (for precise measurements) will be used to measure: The extraction site and the length of the archwire between: (a) Distal aspect of canine bracket on one side to distal of canine bracket on the opposite side (anterior segment), (b) mesial of premolar to distal of molar tube (the area of interest). The wire segment between the premolar bracket and molar tube will be used for testing in this study because this buccal inter�’bracket wire segment is more prone to sliding of the archwire through the molar tube during space closure. 0.019†× 0.025†stainless steel, will be left passive intra�’orally for about 6 weeks for the expression of torque. After completion of these six weeks the wire will be retrieved. This wire will be cut into anterior and posterior segments. The wire will then be stored in sterile vacuum sealed dark pouches which will be coded according to the base code. The posterior two segments of the archwire (1 will be coated and 1 uncoated), will then be sent for assessment of frictional resistance and to check for surface roughness of the wire. The frictional resistance of wires will be checked using Universal Testing Machine. In this study, the brackets will be attached at the intersecting point of horizontal and vertical reference lines. The experimental procedure will be carried out under dry conditions and room temperature using a Universal Testing Machine (UTM). The SS plate with the bracket will be attached to the friction testing device. The straight part of the posterior segment of wire will be cut up to 20mm. This straight segment of each wire will then be ligated to the bracket with stainless steel ligature. One end of the wire will be fixed to the upper arm of UTM and the other end of the wire will be placed in the slot and secured with stainless steel ligature. The load cell will register the force levels required to move the wire along the bracket. This level will then be transmitted to the computer hard disk. The wire will be moved on the bracket at a crosshead speed of 0.5 mm/min. The unit for calculating the load values of frictional resistance is Newton (N). The surface roughness of wire will be checked using scanning electron microscope at 3000x magnification at 15kV. The wires will be checked for the amount of striations, surface elevations, voids, whorls, dents, debris, dark patches and other irregularities of the surface. To check the anti-microbial effect of silver coating, two Recombigen swabs will then be taken immediately after retrieval of the wire; from the anterior segment: (1) from the side which is coated with silver and (2) on the uncoated side. These swabs will then be taken to the microbiology laboratory to assess bacteria like Lactobacillus acidophilus and Streptococcus mutans. Phosphate buffered saline will be used as the transport medium. The swab with the transport media will then be stored at 25ⰠC temperature in a leak proof container. Streptococcus mutans will be cultured on blood agar. Lactobacillus acidophilus will be cultured in MRS broth. They will be incubated in a Sesw 28L incubator at 35Ⱐto 37ⰠC for 24 to 48 hours. Colony forming units (CFUs) will be calculated. The sample when sent for these investigations, will be coded, such that double blinding will be assured. |