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CTRI Number  CTRI/2025/01/079111 [Registered on: 21/01/2025] Trial Registered Prospectively
Last Modified On: 17/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   Comparative Assessment of Antimicrobial Property and Bond Strength of Orthodontic Adhesive Containing Chitosan and Silver Nanoparticles: A Randomized Controlled Study 
Scientific Title of Study   An Evaluation and Comparison of Microbial Colonisation and Bond Failure of Brackets Bonded with Orthodontic Adhesive Modified with Chitosan and Silver Nanoparticles: A Randomized Controlled Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Isha Somvanshi 
Designation  MDS Resident 
Affiliation  Manubhai Patel Dental College and Hospital 
Address  Dept of Orthodontics and Dentofacial Orthopaedics, Manubhai Patel Dental College and Hospital, Vishwajyoti Ashram, Near Vidyakunj School, Mujmahuda, Vadodara

Vadodara
GUJARAT
390011
India 
Phone  8460325989  
Fax    
Email  isha06somvanshi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR PADMAJA ARORA 
Designation  Professor 
Affiliation  Manubhai Patel Dental College and Hospital, Vadodara 
Address  Dept of Orthodontics and Dentofacial Orthopaedics, Manubhai Patel Dental College and Hospital, Vishwajyoti Ashram, Near Vidyakunj School, Mujmahuda, Vadodara

Vadodara
GUJARAT
390011
India 
Phone  9033975429  
Fax    
Email  padmaja2216@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  DR ISHA SOMVANSHI 
Designation  MDS RESIDENT 
Affiliation  Manubhai Patel Dental College and Hospital 
Address  Dept of Orthodontics and Dentofacial Orthopaedics, Manubhai Patel Dental College and Hospital, Vishwajyoti Ashram, Near Vidyakunj School, Mujmahuda, Vadodara

Vadodara
GUJARAT
390011
India 
Phone  8460325989  
Fax    
Email  isha06somvanshi@gmail.com  
 
Source of Monetary or Material Support  
Dept of Orthodontics and Dentofacial Orthopaedics, Manubhai Patel Dental College and Hospital, Vishwajyoti Ashram, Near Vidyakunj School, Mujmahuda, Vadodara, Gujarat, India-390011 
 
Primary Sponsor  
Name  Dr Isha Somvanshi 
Address  D-117, Sugam Park-1, Near Reva Park, Waghodia Road, Vadodara, Gujarat-390025 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Indian Council of Medical Research  Indian Council of Medical Research ICMR, AIIMS Campus, New Delhi 110029 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Isha Somvanshi  Manubhai patel Dental College and Hospital, Vadodara  Dept of Orthodontics and Dentofacial Orthopaedics, Manubhai Patel Dental College and Hospital, Vishwajyoti Ashram, Near Vidyakunj School, Mujmahuda, Vadodara, Gujarat-390011
Vadodara
GUJARAT 		 8460325989

isha06somvanshi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE (IEC) FOR RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional orthodontic adhesive  Conventional orthodontic adhesive with no additional nanoparticles which will be used for bonding orthodontic brackets during fixed orthodontic therapy. Sample collection to check antimicrobial property will be done after 28th day from the date of bonding. Debond rate will be checked upto 6 months from the day of bonding.  
Intervention  Orthodontic adhesive modified with chitosan nanoparticles  4 gm of adhesive (3M Unitek Transbond XT, Monrovia, CA, USA) will be incorporated with chitosan nanoparticles (100 mg) to achieve a concentration of 2.5% using glass slab and mixing spatula in semi dark room for 3-5 minutes. This orthodontic adhesive will be used for bonding orthodontic brackets during fixed orthodontic therapy. Sample collection to check antimicrobial property will be done after 28th day from the date of bonding. Debond rate will be checked upto 6 months from the day of bonding.  
Intervention  Orthodontic adhesive modified with silver nanoparticles  4 gm of adhesive 3M Unitek Transbond XT, Monrovia, CA, USA) will be incorporated with Ag-NPs (2 microgram) to achieve a concentration of 0.05% using glass slab and mixing spatula in semi dark room for 3-5 minutes. This orthodontic adhesive will be used for bonding orthodontic brackets during fixed orthodontic therapy. Sample collection to check antimicrobial property will be done after 28th day from the date of bonding. Debond rate will be checked upto 6 months from the day of bonding.  
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  Patients who give consent for the study.
Patients with mild crowding requiring fixed orthodontic treatment.
Patients with good oral hygiene and healthy periodontium, OHI-S index score in the range of good to fair.
 
 
ExclusionCriteria 
Details  Patients who do not give consent for the study
Patients with moderate to severe crowding
Patients with compromised periodontium
Systemic illnesses like uncontrolled diabetes mellitus, AIDS or any other immunocompromised conditions
Patients on medications that causes gingival hyperplasia or antibiotics
Missing teeth in the anterior region (15-25) in the upper arch
Patients with localized gum disease
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Evaluate and compare of antimicrobial properties of orthodontic adhesive modified with chitosan nanoparticles, silver nanoparticles and conventional orthodontic adhesive  Plaque sample will be collected around the brackets after 28th day (after 4 weeks) from the date of bonding 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluate & compare bond failure or debond rate of the brackets bonded with orthodontic adhesive modified with chitosan nanoparticles & silver nanoparticles & conventional orthodontic adhesive  Bond failure will be recorded upto 6 months from the date of bonding 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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/ Phase 3 
Date of First Enrollment (India)   03/02/2025 
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="1"
Months="6"
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  

This will be a randomized controlled trial. 72 patients undergoing orthodontic treatment will be selected for the study. Each participant will be treated with fixed pre-adjusted appliance. The system used will be metal 0.022 x 0.028” slot MBT prescription bracket system.

Orthodontic Adhesive Modification:

Orthodontic adhesive containing chitosan nanoparticles: 4 gm of orthodontic adhesive (3M Unitek Transbond XT, Monrovia, CA, USA) will be incorporated with CH-NPs (100 mg) to achieve a concentration of 2.5% using glass slab and mixing spatula in semi dark room.

Orthodontic adhesive containing silver nanoparticles: 4 gm of orthodontic adhesive (3M Unitek Transbond XT, Monrovia, CA, USA) will be incorporated with Ag-NPs (2 microgram) to achieve a concentration of 0.05% using glass slab and mixing spatula in semi dark room.

Both chitosan and silver nanoparticles will be bought from Nanoarray Biosciences Pvt Ltd, Valsad, Gujarat, India.

Allocation Method: Patient selection will be done as per the inclusion and exclusion criteria. Participants will be randomly divided into 3 groups:

(1)        In which bonding will be done with conventional orthodontic adhesive

(2)        In which bonding will be done with orthodontic adhesive modified with chitosan nanoparticles

(3)        In which bonding will be done with orthodontic adhesive modified with silver nanoparticles

The experiment will be a single blinded study conducted by keeping the participants blinded about the groups to prevent the bias.

The patients to be treated with fixed appliances will be selected for this study. 0.022 x 0.028” slot MBT prescription bracket system will be used in selected patients. Patients will be divided randomly into 3 groups- conventional orthodontic adhesive will be used for bonding for 1st group, orthodontic adhesive modified with chitosan nanoparticles will be used for 2nd group and orthodontic adhesive modified with silver nanoparticles will be used for 3rd group. The patients will be checked for crowding, with all anterior teeth present in the upper arch and Oral Hygiene Index-Simplified (OHI-S) given by John C Greene and Jack R Vermillion.

For crowding status, upper anteriors will be classified as: mild(1-3mm), moderate(3-6mm) and severe(>6mm).

For OHI-S scoring, 6 surfaces, i.e., facial surfaces of 16, 26, 11 and 31 and lingual surfaces of 36 and 46 will be examined. These teeth will be examined for debris index-simplified (DI-S) and calculus index-simplified (CI-S).

OHI-S = DI-S +CI-S

All the teeth from 15 to 25 in the upper arch will be cleaned and etched with 37% phosphoric acid then bonding agent will be applied and cured for 15 seconds, followed with bonding the bracket with the orthodontic adhesive according to patient allocation.

Sample collection for antimicrobial test: Sample collection will be done 4 weeks after bonding. Plaque sample will be collected from the labial surfaces immediately surrounding the orthodontic brackets of all the teeth from 15 to 25 using a sterile scaler with the 4-pass technique. If any bracket gets debonded before 28th day, it will be excluded for microbial sample collection. The sample will be stored in a test tube containing saline before being sent to the Genexis Biotech Pvt. Ltd, Vadodara, Gujarat, India, for a microbiology test.

To check bond failure (number of brackets debonded): Patients will be instructed not to chew on hard or sticky food once the brackets are bonded. Number of brackets debonded (bond failure) will be recorded within six months from the date of bonding. The debonded brackets will be sandblasted and rebonded with conventional adhesive. Thereafter, the amount of bond failure of rebonded brackets will not be considered.

Following instructions will be given to all the patients:

•           Brush after every meal

•           Not to use any other method like chlorhexidine mouthwash for oral hygiene for the period of study

To check the microbial colonisation: Plaque sample will be collected in a container and will be inoculated in BHI Broth for isolation of S. mutans. Grown culture will be used for serial dilution, plated on chrome agar plates for specific identification of bacterial growth. The different colour colonies will be further inoculated in BHI Broth and will be incubated overnight at 37°C for growth.  Bacterial isolate will be used for genomic DNA extraction, G DNA will be isolated using Genomic DNA extraction kit, followed by 16srdna using universal primers for 16srDNA, PCR samples will be confirmed on (0.8%) agarose gel electrophoresis. PCR sample will be purified using PCR clean up kit. PCR cleanup product will be sent for sequencing.  Protocol used for PCR amplification will be followed accordingly. Thermocycle conditions are 94°C 3 minutes, 94°C 45 seconds, 50°C 60 seconds, 72°C 90 seconds, Repeat steps 2-4 35 times, 72°C 10 minutes, 4°C HOLD.

For Results – Colony Forming Units (CFU) will be counted.

 

 

 

 
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