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CTRI Number  CTRI/2024/06/068620 [Registered on: 10/06/2024] Trial Registered Prospectively
Last Modified On: 07/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Clinical evaluation of zinc oxide nanoparticles - containing cavity cleaning agent used in molar milk teeth of children. 
Scientific Title of Study   Clinical evaluation of the effectiveness of Zinc Oxide nanoparticles-containing cavity disinfectant on the retention of restorations in carious primary molars 
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. Abhinaya Ananthakumar 
Designation  First year post graduate student 
Affiliation  JSS Dental College and Hospital 
Address  Room no 5, Department of Pediatric and Preventive Dentistry, JSS Dental College and Hospital, JSSAHER, Bannimantap, Mysuru , Karnataka

Mysore
KARNATAKA
570015
India 
Phone  8903402142  
Fax    
Email  abhinaya17.ananth@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR Seema Deshmukh 
Designation  Reader 
Affiliation  JSS Dental College and Hospital 
Address  Room no 05, Department of Pediatric And Preventive Dentistry, JSS Dental College and Hospital, Bannimantap, Mysuru, Karnataka 570015

Mysore
KARNATAKA
570015
India 
Phone    
Fax    
Email  seema.pedo@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Abhinaya Ananthakumar 
Designation  First year post graduate student 
Affiliation  JSS Dental College and Hospital 
Address  Room no 5, Department of Pediatric and Preventive Dentistry, JSS Dental College and Hospital, Bannimantap, Mysuru, Karnataka 570015

Mysore
KARNATAKA
570015
India 
Phone  8903402142  
Fax    
Email  abhinaya17.ananth@gmail.com  
 
Source of Monetary or Material Support  
JSS Dental College and Hospital, Bannimantap, Mysuru, Karnataka 570015 
 
Primary Sponsor  
Name  JSS Dental College and Hospital 
Address  Mysuru, Karnataka, India 570015 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Abhinaya Ananthakumar  JSS Dental College and Hospital, Mysuru, Karnataka 570015 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Abhinaya Ananthakumar  JSS Dental College and Hospital  Room no 5, Department of Pediatric and Preventive Dentistry, JSS Dental College and Hospital, Bannimantap
Mysore
KARNATAKA 
8903402142

abhinaya17.ananth@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JSS DENTAL COLLEGE AND HOSPITAL INSTITUTIONAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K025||Dental caries on pit and fissure surface, (2) ICD-10 Condition: A488||Other specified bacterial diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Chlorexidine gel  positive control used as cavity disinfectant topical application of the solution onto the floor of the cavity for 60 seconds and will be washed and dried. 
Comparator Agent  saline   negative control used as cavity disinfectant topical application of the solution onto the floor of the cavity for 60 seconds and will be washed and dried. 
Intervention  Zinc oxide Nanoparticles  Cavity disinfectant topical application of the solution onto the floor of the cavity for 60 seconds and will be washed and dried. 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  Children included-
1.within age of 6-9 years with presence of caries in any primary 1st and 2nd molar
2. moderately deep cavities (ICDAS II caries score 4,5,6) limited to single-surface occlusal lesions
3.systemically healthy and cooperative children (Frankl scale 3 and 4)
Radiographic criteria:
1.Children with caries involving enamel, dentin and with at least remaining dentin thickness of at least 0.5mm
 
 
ExclusionCriteria 
Details  Children with-
1.intellectual disability
2.systemic illness and on long term medication
3.presence of root stumps in oral cavity
4.presence of open carious lesions in oral cavity
5.with any known allergy
6.buccal/lingual extension
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the effect of zinc oxide nanoparticles containing cavity disinfectant with that of commercially available chlorhexidine gel on retention of the restorations using FDI clinical scoring criteria
 
assessed at baseline, 3 months, and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
1.To evaluate & compare the antimicrobial activity of zinc oxide nanoparticles with that of commercially available chlorhexidine gel as a cavity disinfectant in the prepared cavity by using microbial plating.
2.To evaluate & compare the ultrastructure of dentin tubules after disinfection with a zinc oxide-incorporated disinfectant & chlorhexidine on sectioned teeth through scanning electron microscopy (in vitro).
 
at baseline, 3 months, 6 months 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
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 3/ Phase 4 
Date of First Enrollment (India)   20/06/2024 
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="7"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [abhinaya17.ananth@gmail.com].

  6. For how long will this data be available start date provided 11-06-2024 and end date provided 30-03-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Dental caries is a common oral health problem in children characterized by the destruction of tooth structures at various levels. With the advent of minimally invasive techniques, bacteria in the affected carious tissue are still left behind after removing infected tissue. Microgaps around the restorations can form at margins due to polymerization shrinkage and chewing pressures. This could promote bacterial growth, particularly S. mutans, under the restoration, causing secondary caries and reducing longevity of the restoration. Thus, to overcome this, the concept of cavity disinfectants was introduced. Disinfecting the cavity after caries removal helps prevent recurrent caries, post-procedure sensitivity, and restoration failure. Several studies have reported using chlorhexidine, sodium hypochlorite, and silver, zinc, and titanium nanoparticles as cavity disinfectants. Nanoparticles are small size particles ranging from 1 to 100 nm. They exhibit efficient antibacterial properties, protect adhesives from degradation, prevent caries, inhibit biofilm formation and maturation, and promote remineralization. Among various metals that are being modified and incorporated in combination with oxide, zinc is known for its biocompatibility antibacterial effects. According to US-FDA, zinc oxide is considered as generally recognized as safe (GRAS) substance. Zinc oxide nanoparticles (ZnONPs) are chosen for their minimal cytotoxicity in human cells and as antibacterial even at low concentrations. In vitro studies confirm that ZnO NP cavity disinfectants outperform alternatives in antibacterial efficacy without compromising restoration bonding strength. The purpose of the study is to evaluate the efficacy of the zinc oxide nanoparticles - containing cavity disinfectant as an alternative to commercially available ones, with effective antimicrobial activity and unpertubed retention of the restorations placed over the cavity. 

 
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