| CTRI Number |
CTRI/2026/01/102271 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic Preventive Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
To compare the effect of different mouthwashes on surface roughness of Nickel-Titanium wires. |
|
Scientific Title of Study
|
An in vivo study to evaluate and compare the effect of various mouthwashes on the surface roughness of Nickel-Titanium wires. |
| Trial Acronym |
IVCT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Archana Jatania |
| Designation |
Professor and Head of department |
| Affiliation |
Saraswati dhanwantari dental college and hospital, parbhani |
| Address |
Department of orthodontics and dentofacial orthopaedics, Saraswati dhanwantari dental college and hospital, Parbhani Dr. Prafulla patil multispeciality hospital, Parbhani Parbhani MAHARASHTRA 431401 India |
| Phone |
7719835493 |
| Fax |
|
| Email |
ajatania8@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Archana Jatania |
| Designation |
Professor and Head of department |
| Affiliation |
Saraswati dhanwantari dental college and hospital, parbhani |
| Address |
Saraswati dhanwantari dental College and hospital, parbhani Dr. prafulla patil multispeciality hospital, Parbhani Parbhani MAHARASHTRA 431401 India |
| Phone |
7719835493 |
| Fax |
|
| Email |
ajatania8@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr. Archana Jatania |
| Designation |
Professor and Head of department |
| Affiliation |
Saraswati dhanwantari dental college and hospital, parbhani |
| Address |
Department of orthodontics and dentofacial orthopaedics, Saraswati dhanwantari dental College and hospital, parbhani Dr. prafulla patil multispeciality hospital, parbhani Parbhani MAHARASHTRA 431401 India |
| Phone |
7719835493 |
| Fax |
|
| Email |
ajatania8@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ashish Kapse |
| Address |
Saraswati dhanwantari dental college and hospital, parbhani |
| Type of Sponsor |
Other [] |
|
|
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 Ashish Kapse |
Department ofSaraswati dhanwantari dental college and hospital, Parbhani |
Third floor,Department number 7, Department of orthodontics and dentofacial orthopaedics Parbhani MAHARASHTRA |
8857957505
ashishkapse2007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDDC PBN IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Other disorders of teeth and supporting structures |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Surface roughness of Ni-Ti wires after using differemt mouthwashes. |
The study will be conducted on 60 patients undergoing fixed orthodontic treatment in the Department of Orthodontics and Dentofacial Orthopaedics and patients willing to participate in the study will be asked to provide the written consent form.
Patients will be randomly assigned to four groups of 15 patients each.
Constitution of groups:
60 patients will be selected for study and will be grouped as follows:
Group A- chlorhexidine (CLOHEX ADS) mouthwash (n=15)
Patients in this group will be given chlorhexidine (CLOHEX ADS)mouthwash and will be advised to use it twice daily. Patient will be educated about how to use the mouthwash. Instructions to maintain proper oral hygiene will be given.
Group B- fluoride containing (Sensodyne complete protection+) mouthwash (n=15)
Patients in this group will be given fluoride containing (Sensodyne complete protection+) mouthwash and will be advised to use it twice daily. Patient will be educated about how to use the mouthwash. Instructions to maintain proper oral hygiene will be given.
Group C- probiotic (perfora) mouthwash (n=15)
Patients in this group will be given probiotic (perfora) mouthwash and will be advised to use it twice daily. Patient will be educated about how to use the mouthwash. Instructions to maintain proper oral hygiene will be given.
Group D- control group (n=15)
Patients in this group are used as control group. They will be advised to brush twice daily with toothpaste and instructions to maintain proper oral hygiene will be given.
|
| Intervention |
Probiotic Mouthwash
chlohex-ADS mouthwash
Sensodyne complete protection Plus mouthwash
|
The study will be conducted on 60 patients undergoing fixed orthodontic treatment in the Department of Orthodontics and Dentofacial Orthopaedics and patients willing to participate in the study will be asked to provide the written consent form.
Patients will be randomly assigned to four groups of 15 patients each.
Constitution of groups:
60 patients will be selected for study and will be grouped as follows:
Group A- chlorhexidine (CLOHEX ADS) mouthwash (n=15)
Patients in this group will be given chlorhexidine (CLOHEX ADS)mouthwash and will be advised to use it twice daily. Patient will be educated about how to use the mouthwash. Instructions to maintain proper oral hygiene will be given.
Group B- fluoride containing (Sensodyne complete protection+) mouthwash (n=15)
Patients in this group will be given fluoride containing (Sensodyne complete protection+) mouthwash and will be advised to use it twice daily. Patient will be educated about how to use the mouthwash. Instructions to maintain proper oral hygiene will be given.
Group C- probiotic (perfora) mouthwash (n=15)
Patients in this group will be given probiotic (perfora) mouthwash and will be advised to use it twice daily. Patient will be educated about how to use the mouthwash. Instructions to maintain proper oral hygiene will be given.
Group D- control group (n=15)
Patients in this group are used as control group. They will be advised to brush twice daily with toothpaste and instructions to maintain proper oral hygiene will be given.
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
2] Patients with permanent dentition
3] Patients with well aligned arches
4] Patients having good oral hygiene |
|
| ExclusionCriteria |
| Details |
1] Patients with history of any systemic disease
2] Patients with periodontal disease
3] Patients with carious teeth
4] pregnant and breast feeding women |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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 |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| which mouthwash is best suited during orthodontic tooth movement, to keep oral hygiene status good & reduce friction during orthodontic treatment. |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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 2 |
|
Date of First Enrollment (India)
|
01/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/03/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="7" |
|
Recruitment Status of Trial (Global)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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 - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Informed Consent Form Response - Clinical Study Report
- 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 (Others) -
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
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. | |