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CTRI Number  CTRI/2025/07/091130 [Registered on: 18/07/2025] Trial Registered Prospectively
Last Modified On: 16/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   IN-VITRO 
Study Design  Other 
Public Title of Study   check the medicinal capacity of a naturally occuring substance to reduce cavities in children  
Scientific Title of Study   EVALUATION OF ANTIMICROBIAL EFFICACY AND REMINERALIZATION POTENTIAL OF NANOCHITOSAN COATED STAINLESS STEEL BANDS AT DIFFERENT INTERVALS– AN IN-VITRO STUDY  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
NIL  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr TANUSHREE 
Designation  Post Graduate 
Affiliation  Rajarajeswari Dental college and hospital 
Address  Rajarajeswari Dental college and hospital
Department of pediatric and preventive dentistry
Bangalore Rural
KARNATAKA
560074
India 
Phone  09686617545  
Fax    
Email  tanushreepthk0@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Amrutha U B 
Designation  Associate Professor 
Affiliation  Rajarajeswari Dental college and hospital 
Address  Rajarajeswari Dental college and hospital Ramohalli cross , Mysore road
Department of pediatric and preventive dentistry
Bangalore Rural
KARNATAKA
560074
India 
Phone  8105700221  
Fax    
Email  amrutha.b87@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr TANUSHREE 
Designation  Post Graduate 
Affiliation  Rajarajeswari Dental college and hospital 
Address  Rajarajeswari Dental college and hospital
Department of pediatric and preventive dentistry
Bangalore Rural
KARNATAKA
560074
India 
Phone  09686617545  
Fax    
Email  tanushreepthk0@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Tanushree  
Address  Rajarajeswari Dental college and hospital Department of pediatric and preventive dentistry No. 17 Ramohalli cross Kumbalgodu Mysore road Bengaluru 560074 
Type of Sponsor  Other [SELF FUNDED] 
 
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 TANUSHREE  Rajarajeswari Dental college and hospital  Rajarajeswari Dental college and hospital Department of pediatric and preventive dentistry Room No. 5 No. 17 Ramohalli cross Kumbalgodu Mysore road Bengaluru 560074 Rajarajeswari Dental college and hospital Department of pediatric and preventive dentistry No. 17 Ramohalli cross Kumbalgodu Mysore road Bengaluru 560074
Bangalore Rural
KARNATAKA 		 09686617545

tanushreepthk0@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Rajarajeswari Dental College and Hospital, Bangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Periodontically compromised tooth 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Extracted molar teeth with intact buccal and lingual surfaces will be included in this study 
 
ExclusionCriteria 
Details  Grossly decayed coronal structure

Hypoplastic tooth

Tooth with fluorosis

Developmental defects 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate at 1 week and 1 month interval

Antimicrobial efficacy of nanochitosan coated and noncoated SS bands.

Remineralization potential of nanochitosan coated and noncoated SS bands. 		 Baseline , 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
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   N/A 
Date of First Enrollment (India)   25/08/2025 
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="2"
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 - NO
Brief Summary  

A total of 60 sound molar teeth extracted will be taken for this study. The debris will be removed, teeth will be cleaned using ultrasonic scaler and will be stored in distilled water. All selected teeth will be used within three months of collection. 

 

Preparation of SS bands

SS bands will be cleaned with acetone and ethanol and washed with distilled water and air dried. 

Preparation of chitosan solution 

0.5g of chitosan nanoparticle will be added to 20 vol percentage distilled water and 1 vol percentage acetic acid followed by magnetic stirring for 30min until chitosan is dissolved. 

79 vol percentage Ethanol will be added to reduce the unsolicited hydrolysis of water during EPD. 

Suspension will be stirred magnetically for an hour followed by ultrasonication for 1 hr. 

Electrophoretic coating process

Electrophoretic deposition will be done for coating purpose in which working and counter electrodes will be SS bands and the distance between the electrodes will be 1cm. The procedure will be carried at different voltages of 13V,15V, and 20V for 5 mins. 

Coating characterization 4 SS bands will randomly be selected from the 30 coated bands and subjected to SEM evaluation, to analyze coating thickness and elemental composition. 

Preparation of artificial saliva 

   The artificial saliva used in this present study will be prepared  

The pH of artificial saliva will be adjusted to 6.75 with KOH. 

 PREPERATION OF SAMPLE

All teeth will be cut at the cementoenamel junction using an angular diamond disk bur. The teeth will be cut mesiodistally into two halves measuring 0.7mmx1.2cm and the bands of size 0.5mmx1cm will be used to cement on the teeth using luting glass ionomer cement.  

 

Prepared samples will be broadly divided into two groups

Experimental group I 30 Coated SS bands 

Experimental group II 30 Non coated SS bands 

 

 

Experimental group I will be subdivided into 

Group Ia 15 teeth will be subjected for antimicrobial analysis 

Group Ib 15 teeth will be checked for remineralization potential  

 

Experimental group II will be subdivided into 

Group IIa 15 teeth will be subjected for antimicrobial analysis 

Group IIb 15 teeth will be checked for remineralization potential 

All the experimental teeth will be immersed in 60 test tubes each containing 15ml artificial saliva. 

At 1 week and 1 month interval 2ml saliva will be subjected to microbial analysis and to check remineralization potential from respective test tubes. 

The obtained results will be further given for statistical analysis. 

 
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