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CTRI Number  CTRI/2021/07/034736 [Registered on: 09/07/2021] Trial Registered Prospectively
Last Modified On: 20/04/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A comparative evaluation of the effect of two types of mouthwashes on the bacterial flora and health of the oral cavity  
Scientific Title of Study   A comparative evaluation of Silver-Nano particle containing Mouthwash with Chlorhexidine on the colonization of microflora and gingival health: A Double-blind RCT  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shrestha Bisht 
Designation  2nd Year Post Graduate student 
Affiliation  Subharti Dental College & Hospital 
Address  Department of Orthodontics and dentofacial orthopaedics, Subharti Dental College and Hospital, Swami Vivekanand Subharti University Meerut

Meerut
UTTAR PRADESH
250005
India 
Phone  9568301324  
Fax    
Email  drshresthabisht@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pradeep Raghav 
Designation  Professor and Head Department of Orthodontics 
Affiliation  Subharti Dental College & Hospital 
Address  Department of Orthodontics and dentofacial orthopaedics, Subharti Dental College and Hospital, Swami Vivekanand Subharti University Meerut

Meerut
UTTAR PRADESH
250005
India 
Phone  9837175914  
Fax    
Email  drpradeepraghav@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shrestha Bisht 
Designation  2nd Year Post Graduate student 
Affiliation  Subharti Dental College & Hospital 
Address  Department of Orthodontics and dentofacial orthopaedics, Subharti Dental College and Hospital, Swami Vivekanand Subharti University Meerut

Meerut
UTTAR PRADESH
250005
India 
Phone  9568301324  
Fax    
Email  drshresthabisht@gmail.com  
 
Source of Monetary or Material Support  
Dept of Orthodontics, Subharti Dental College, Subharti University, Meerut. 
 
Primary Sponsor  
Name  Dr Shrestha Bisht 
Address  Department of Orthodontics and dentofacial orthopedics Subharti dental College, Swami Vivekanand Subharti University 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shrestha Bisht  Subharti Dental College and Hospital  Department of Orthodontics and dentofacial orthopedics Room No. 7 2nd floor Subharti University dental College, Swami Vivekanand Subharti University Meerut UTTAR PRADESH
Meerut
UTTAR PRADESH 		 09568301324

drshresthabisht@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institution of Ethical Committee, Subharti Dental College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Patients requiring fixed orthodontic treatment for the correction of malocclusion 
Patients  (1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  0.2% Chlorhexidine mouth rinse   The participants will start using mouthrines after 4 weeks of bonding. They will be using the mouthrinse for one month 
Comparator Agent  Mint water- placebo  The participants will start using it after 4 weeks of bonding. They will be using it for one month 
Intervention  Silver Nano-particle containing mouthrinse (NanOlife Dhanvantri Nano Ayushodi Pvt. Ltd.)  The participants will start using mouthrines after 4 weeks of bonding. They will be using the mouthrinse for one month 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1.Subjects’ willingness to participate. 2.The indication for fixed orthodontic treatment, between 15-30years of age. 3.Lack of dental caries and/or restorations. 4.Absence of severe dental plaque (plaque index ≤ 20% measured by O’Leary index using plaque disclosing agent) / severe gingival inflammation/severe periodontal condition. 5.Absence of any systemic diseases. 6.Not having used any mouth rinses for at least 1 month before the initiation of the study. 7.Not on antibiotics and/or anti inflammatory drugs in the past 3 months
 
 
ExclusionCriteria 
Details  1.History of previous periodontal treatments.
2.Active periodontal diseases.
3.Mouth breathing or any other problems which could affect oral microbial flora.
4.Presence of dental crowding(>4mm).
5.Sign of sensitivity to mouthwashes during the study
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the effectiveness of silver nanoparticle mouthwash and Chlorhexidine mouthwash on gingival health and count of microorganisms during fixed orthodontic treatment.  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the effectiveness of silver nanoparticle mouthwash on gingival health and colonization of microorganisms during fixed orthodontic treatment.
 		 3 months 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   N/A 
Date of First Enrollment (India)   19/07/2021 
Date of Study Completion (India) 30/11/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="7" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  		 Fixed orthodontic therapy increases plaque retention areas and jeopardizes oral hygiene maintenance and hence is a risk factor for plaque accumulation. The complex design of orthodontic bands and brackets may create an ecological environment that facilitates the establishment and growth of cariogenic bacteria. Design and surface characteristics of both orthodontic attachment and roughness of the composite influence plaque retention. This undisturbed plaque induces gingivitis, gingival hyperplasia, and periodontitis which itself might interfere with orthodontic outcome by detachment of connective tissue and inhibition of remodelling and also leads to the development of dental caries and white spot lesions due to enamel demineralization. Although mechanical removal of dental biofilm is still considered the main method, routine brushing protocols might not suffice to reduce the increased plaque accumulation in orthodontic patients. A recent literature review suggested that improved antimicrobial solutions are urgently needed to prevent biofilm-related complications of orthodontic treatment. The use of mouth rinses has been introduced as an effective way of reducing dental plaque accumulation. Orthodontic patients are prescribed various chemical agents such as chlorhexidine, Listerine, etc. Among frequently used antiseptic mouthwashes, Chlorhexidine (CHX) is known as the most potent chemical agent. However, CHX has side effects like discolouration of the teeth, irritation of oral mucosal, and an unpleasant taste. Therefore, the search for other antimicrobial substances with fewer side effects continues. One such novel mouth rinses is mouthwash containing Silver Nanoparticles (SNP). Silver and its derivatives are the oldest antimicrobial agent in traditional medicine. SNP are stable in solutions and their antimicrobial properties can remain for a long time. SNP release silver ions with a positive charge. These ions may cling to DNA and proteins, because these molecules contain compounds with a negative charge, such as phosphorus and sulphur. Furthermore, Ag ions may cling to the surface of the microorganisms causing disruption in the integrity of the cell wall, and hence are bactericidal. SNPs present a greater surface-to-volume ratio (per unit mass), interacting more closely with microbial membranes and provide a considerably larger surface area for antimicrobial activity. A commercially available mouthwash containing SNP is NanOlife (Dhanvantri Nano Ayushodi Pvt. Ltd.) The mouthwash is alcohol-free and contains Ag- 100% NP prepared by innovative Green Nanotechnology. Although the benefits of using SNP mouthwash is present in literature, not many clinical studies are done to prove its efficacy in the oral environment. Hence, the aim of this study is to compare the effect of Silver Nanoparticles containing (NanOlife) mouthwash with CHX on the colonization of microorganisms on the fixed orthodontic elastomeric modules and on the gingival health of the patients.

 
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