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Clinical Trials/CTRI/2026/01/102271
CTRI/2026/01/102271
Active, not recruiting
Phase 2

An in vivo study to evaluate and compare the effect of various mouthwashes on the surface roughness of Nickel-Titanium wires.

Ashish Kapse1 site in 1 country60 target enrollmentStarted: March 1, 2026Last updated:

Overview

Phase
Phase 2
Status
Active, not recruiting
Sponsor
Ashish Kapse
Enrollment
60
Locations
1
Primary Endpoint
To check if the intervention that is probiotic mouthwash has a beneficial effect in reducing surface roughness of the archwire in patient undergoing orthodontic treatment

Overview

Brief Summary

Comprehensive orthodontic treatment planning includes leveling and aligning, space closure and finishing and detailing which depends significantly on the effective use of various archwires.1

Archwires used in the orthodontic treatment possess physical properties like resilience, formability, spring back, corrosion resistance, shape memory, superelasticity, biocompatibility, thermal and electrical conductivity, surface roughness, mechanical strength and fatigue resistance making them widely acceptable in orthodontic treatments. The predictability of outcome of the treatment progress depends upon the physical, mechanical and biochemical properties of the arch wire.2

Different archwires possess different alloys that are employed to generate the biomechanical forces required for tooth movement. Nickel-Titanium (Ni-Ti) and stainless steel (SS) alloys are the most commonly used materials for the fabrication of orthodontic archwires.3 In recent years, Ni-Ti alloys have been widely used in orthodontics due to their unique properties, including shape memory, superelasticity and excellent biocompatibility.4

While assessing the quality of Ni-Ti archwires the surface character must be taken into account as this determines the corrosion resistance. The corrosion behaviour of Ni-Ti archwire is positively correlated with the surface roughness of archwires.5 The surface roughness is a crucial factor as it affects archwire-guided tooth movement, corrosion resistance, biocompatibility, color stability and frictional properties. Corrosion brings about the leaching out of ions from alloys which eventually causes the surface roughness which is most commonly noticed in Ni-Ti wires.6

Maintaining good oral hygiene and effective caries control is one of the key factors for achieving successful orthodontic treatment outcomes. Orthodontic treatment involves the use of bands, wires and ligatures making it challenging to maintain proper oral hygiene. This invariably leads to plaque build up that causes gingivitis and dental caries. To overcome the harmful effects of plaque, mouthwashes are commonly recommended. There are organic and inorganic mouthwashes available in the market that deliver active agents to the teeth to prevent dental caries and gingivitis.7 Various types of mouthwashes are commercially available like chlorhexidine mouthwash, fluoride containing mouthwash, probiotic mouthwash, etc. which are being regularly used by the orthodontic patients.8

Chlorhexidine mouthwash is a broad-spectrum antimicrobial agent that is commonly used to maintain oral hygiene. It helps to control inflammation, minimize plaque accumulation and lower the risk of infection, particularly during fixed orthodontic treatment. Usually offered in 0.12% or 0.2% concentrations and commonly used by rinsing 15 ml in the mouth for 30 seconds twice a day. It is available in various forms including mouthwash, gel and dentifrices and is often used as an adjunct to mechanical plaque control.9

Fluoride-containing commercial mouthwashes, toothpastes, and prophylactic gels are generally used to avoid demineralization or to reduce dental sensitivity. It works by delivering fluoride that helps to remineralize the enamel and makes teeth more resistant to acid attacks from plaque and bacteria. Regular use of fluoride mouthwash can be especially beneficial for individuals prone to caries and those undergoing orthodontic treatments.10

Probiotic mouthwashes are gaining popularity as a natural approach to improving oral health by introducing beneficial bacteria into the mouth. In contrast to traditional mouthwashes that primarily kill harmful bacteria with antiseptic agents, probiotic mouthwashes work by supporting a balanced oral microbiome and helping to create and maintain a healthy environment through the presence of probiotics.11

Although the Ni-Ti wires are considered corrosion resistant some ions may leach out which leads to an increase in surface roughness.12

Very few studies are conducted till date to check the effect of mouthwashes on the orthodontic arch wires. Hence this study is planned to evaluate and compare the effect of commonly used mouthwashes on the Ni-Ti archwires.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
None

Eligibility Criteria

Ages
15.00 Year(s) to 30.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 2] Patients with permanent dentition 3] Patients with well aligned arches 4] Patients having good oral hygiene.

Exclusion Criteria

  • 1] Patients with history of any systemic disease 2] Patients with periodontal disease 3] Patients with carious teeth 4] pregnant and breast feeding women.

Outcomes

Primary Outcomes

To check if the intervention that is probiotic mouthwash has a beneficial effect in reducing surface roughness of the archwire in patient undergoing orthodontic treatment

Time Frame: 4 weeks

Secondary Outcomes

  • which mouthwash is best suited during orthodontic tooth movement, to keep oral hygiene status good & reduce friction during orthodontic treatment.(8 weeks)

Investigators

Sponsor
Ashish Kapse
Sponsor Class
Other []
Responsible Party
Principal Investigator
Principal Investigator

Dr. Archana Jatania

Saraswati dhanwantari dental college and hospital, parbhani

Study Sites (1)

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