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CTRI Number  CTRI/2025/04/083884 [Registered on: 02/04/2025] Trial Registered Prospectively
Last Modified On: 23/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   To assess the efficiency of different methods for disinfecting of deciduous teeth against Escherichia coli in root canal that is infected. 
Scientific Title of Study   Comparison of Antibacterial Efficacy of Different Techniques for Disinfection of Primary Teeth Against Common Pathogen (Enterococcus faecalis) in Infected Root Canal: An Ex Vivo 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 Antra 
Designation  Postgraduate student 
Affiliation  Sardar Patel Post Graduate institute of dental and medical sciences 
Address  Department of Paediatric and Preventive Dentistry

Lucknow
UTTAR PRADESH
226025
India 
Phone  8173809928  
Fax    
Email  antrav540@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anshul Sharma  
Designation  Professor 
Affiliation  Sardar Patel Post Graduate institute of dental and medical sciences 
Address  Department of Paediatric and Preventive Dentistry

Lucknow
UTTAR PRADESH
226025
India 
Phone  9415301634  
Fax    
Email  dranshulsharma84@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Antra 
Designation  Postgraduate student 
Affiliation  Sardar Patel Post Graduate institute of dental and medical sciences 
Address  Department of Paediatric and Preventive Dentistry

Lucknow
UTTAR PRADESH
226025
India 
Phone  8173809928  
Fax    
Email  antrav540@gmail.com  
 
Source of Monetary or Material Support  
Sardar Patel post graduate institute of dental and medical sciences Department of paediatric and preventive dentistry 
 
Primary Sponsor  
Name  Dr Antra 
Address  Department of Paediatric and Preventive dentistry 
Type of Sponsor  Other [Self sponsered] 
 
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 Antra  Sardar Patel post graduate institute of dental and medical sciences  Department number -5 Department of Paediatric and Preventive Dentistry
Lucknow
UTTAR PRADESH 		 8173809928

antrav540@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  2% Chlorhexidine  2% Chlorhexidine at higher concentrations for 30 seconds works as an antimicrobial agent by cytoplasmic precipitation and eventually causing cell lysis when used for disinfection of root canals. 
Comparator Agent  2% Chlorhexidine, 5.25% Sodium hypochlorite, 5% Apple Cider Vinegar, Ozonated water and Diode laser.  2% Chlorhexidine at higher concentrations works as an antimicrobial agent by cytoplasmic precipitation and eventually causing cell lysis when used for disinfection of root canals. All irrigating were used for 30 seconds each. 5.25 % Sodium Hypochlorite ( NaOCl) acts as an antimicrobial agent by dissolution of necrotic pulp tissues when used for the disinfection of root canals. 5% Apple cider vinegar constitutes malic acid and acetic acid which leads to microbial death by passing the cell membrane of microbes eventually reducing the microbial count when used for disinfection of root canals. Ozonated water is used to treat root canals for disinfecting as its a powerful antimicrobial agent that can kill bacteria, viruses, and fungi. It works by oxidizing the cell walls and membranes of microorganisms, which causes them to lyse. Diode laser fibers when introduced inside the root canal emits the laser light, bacteria contains chromophore which are highly sensitive these laser light which leads to bacterial cell death.  
Intervention  5% Apple cider vinegar  5% Apple cider vinegar constitutes malic acid and acetic acid which leads to microbial death by passing the cell membrane of microbes eventually reducing the microbial count when used for disinfection of root canals when used for 30 seconds. 
Intervention  5.25 % Sodium Hypochlorite ( NaOCl)  5.25 % Sodium Hypochlorite ( NaOCl) acts as an antimicrobial agent by dissolution of necrotic pulp tissues when used for the disinfection of root canals for 30 seconds. 
Intervention  Diode Laser  Diode laser fibers when introduced for 30 seconds inside the root canal emits the laser light, bacteria contains chromophore which are highly sensitive these laser light which leads to bacterial cell death.  
Intervention  Ozonated water  Ozonated water when used for 30 seconds is used to treat root canals for disinfecting as its a powerful antimicrobial agent that can kill bacteria, viruses, and fungi. It works by oxidizing the cell walls and membranes of microorganisms, which causes them to lyse.  
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  11.00 Year(s)
Gender  Both 
Details  Children having long standing history of dull pain.
Clinically nonvital tooth.
Deciduous teeth having necrotic pulp.
Deciduous teeth having sinus tract opening.
Deciduous teeth having at least two thirds of root length.
 
 
ExclusionCriteria 
Details  • Deciduous teeth having more than 1/2 of the root length resorbed.
• Deciduous teeth with Obliterated canal.
• Medically compromised child.
• Children who have taken antibiotics within past 2 months.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine the suitable methods for root canal disinfection. Irrigating agents decrease bacterial counts in canals of deciduous teeth roots to achieve a successful treatment outcome.
Therefore, this study aims at helping clinicians in selecting a suitable irrigation method such as Chlorhexidine (CHX), sodium hypochlorite (NaOCl), Diode Laser, Ozonated water and Apple cider vinegar out of all diode laser will be most effective in decreasing the bacterial counts in deciduous teeth.  		 1 week 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "180"
Final Enrollment numbers achieved (India)="180" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   13/04/2025 
Date of Study Completion (India) 28/01/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  
Endodontic therapy is done in primary teeth to prevent unorganised eruption of succedaneous teeth. Pulpectomy includes extirpation from root canals followed by debridement to achieve successful treatment outcome. Complete eradication of pathogens from root canals system cannot be done by instrumentation alone. Pulpectomy is thought to be extremely difficult due to anatomic variation in primary teeth such as furcation connections, horizontal anastomoses etc. Root canal failures mainly occur due to persistent microorganisms within the complex root system even after proper instrumentation. The only way to eliminate these microbes is using effective irrigating methods. Thus, instrumentation must always be accompanied with copious irrigation to completely deride and disinfect root canal. Various irrigating agents have an impact on the areas of canal walls which remain inaccessible to instrumentation such as lateral accessory canals and tortuous intracranial configuration. 
 Therefore, current investigation will be conducted to analyze and subsequently compare the antimicrobial efficacy of 2% Chlorhexidine, Diode laser, Ozonated water, 5.25% NaOCl(Sodium hypochlorite) and Apple cider vinegar on primary teeth with necrotic pulp which consists of variety of microorganisms. 

 
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