AN EVALUATION AND COMPARISION OF FRICTIONAL RESISTANCE, SURFACE ROUGHNESS AND MICROBIAL COLONIZATION OF SILVER COATED AND UNCOATED STAINLESS STEEL ARCHWIRES – AN IN VIVO STUDY
- Conditions
- Periodontal disease, unspecified,
- Registration Number
- CTRI/2024/04/066050
- Lead Sponsor
- Dr Rutvi Raval
- 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 25â° C 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 35â° to 37â° C 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 31
- i.Patients requiring therapeutic extraction of bilateral upper first premolars as a part of the treatment.
- Good oral hygiene and healthy periodontium.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method evaluate and compare frictional resistance of a silver coated and uncoated stainless steel wire 6 weeks
- Secondary Outcome Measures
Name Time Method evaluate & compare microbial colonization of a silver coated & uncoated of stainless steel archwire 6 weeks evaluate & compare surface roughness of a silver coated & uncoated stainless steel wire 6 weeks
Trial Locations
- Locations (1)
Manubhai Patel Dental Hospital
🇮🇳Vadodara, GUJARAT, India
Manubhai Patel Dental Hospital🇮🇳Vadodara, GUJARAT, IndiaDr Rutvi RavalPrincipal investigator9409400440rutvi.vr@gmail.com