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CTRI Number  CTRI/2025/02/081258 [Registered on: 25/02/2025] Trial Registered Prospectively
Last Modified On: 07/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Dentistry 
Study Design  Other 
Public Title of Study   Comparing the Effectiveness of Natural Remedies Like Green Tea, Triphala, and Morinda Citrifolia with Sodium Hypochlorite for Cleaning Infected Root Canals 
Scientific Title of Study   Comparative Evaluation of Effectiveness of Green tea Polyphenoles Triphala Morinda Citrifolia and 5 percent Sodium Hypochorite as intracanal irrigants against isolated microorganisms from infected root canal- an Interventional 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 Daulat Kumar 
Designation  Junior Resident 
Affiliation  Faculty of dental sciences king george medical university 
Address  Department of Paediatric and Preventive Dentistry New Dental Building 4th Floor King George Medical University, Shahmina Road, Chowk , Lucknow

Lucknow
UTTAR PRADESH
226003
India 
Phone  09990016246  
Fax    
Email  daulat2112@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Afroz Alam Ansari 
Designation  Professor 
Affiliation  Faculty of dental sciences king george medical university 
Address  Department of Paediatric and Preventive Dentistry New Dental Building 4th Floor King George Medical University, Shahmina Road, Chowk, Lucknow

Lucknow
UTTAR PRADESH
226003
India 
Phone  9335166662  
Fax    
Email  afrozalamansari@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Daulat Kumar 
Designation  Junior Resident 
Affiliation  Faculty of dental sciences king george medical university 
Address  Department of Paediatric and Preventive Dentistry New Dental Building 4th Floor King George Medical University, Shahmina Road, Chowk , Lucknow

Lucknow
UTTAR PRADESH
226003
India 
Phone  09990016246  
Fax    
Email  daulat2112@gmail.com  
 
Source of Monetary or Material Support  
Dr Daulat Kumar Department of Paediatric and Preventive Dentistry New Dental Building 4th Floor King George Medical University Shahmina Road , Chowk Lucknow 226003 India 
 
Primary Sponsor  
Name  Dr Daulat Kumar 
Address  Department of Paediatric and Preventive Dentistry New Dental Building 4th Floor King George Medical University Shahmina Road Chowk Lucknow 226003 India  
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 Daulat Kumar  Faculty of dental sciences king george medical university  Department of Paediatric and Preventive Dentistry New Dental Building 4th Floor King George Medical University, Shahmina Road, Chowk , Lucknow
Lucknow
UTTAR PRADESH 		 09990016246

daulat2112@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
King Georges Medical University UP Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K040||Pulpitis. Ayurveda Condition: DANTAGATAROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Green tea polyphenols, Reference: NA, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 35(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: -), Additional Information: -
2Intervention ArmDrugOther than Classical(1) Medicine Name: Triphala , Reference: NA, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 25(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: -), Additional Information: -
3Intervention ArmDrugOther than Classical(1) Medicine Name: Morinda Citrifolia, Reference: NA, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 30(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: -), Additional Information: -
4Comparator Arm (Non Ayurveda)-sodium hypochlorite5 ml of 5 percent sodium hypochlorite will be used 2 to 3times for 60 seconds
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  Children aged between 5 and 9 years of both sexes.
Presence of localized swelling sinus and pain on percussion indicating non-vital pulp.
Presence of periapical and furcation radiolucency in periapical radiographs.
Absence of advanced physiologic or pathologic root resorption in X-rays.
Absence of a history of systemic diseases that would contraindicate pulp therapy example infective endocarditis.
No previous history of antibiotic administration or if antibiotics were administered, the last dose was taken at least 2 weeks prior to the study
 
 
ExclusionCriteria 
Details  Presence of advanced physiologic or pathologic root resorption in X-ray.
Uncooperative children.
Teeth with unrestorable crowns.
Teeth with abnormal anatomy and calcified canals.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Colony-Forming Units (CFUs):

Quantification of the number of CFUs obtained from pre- and post-irrigation microbial samples using appropriate culture techniques. 		 baseline , 1 week 
 
Secondary Outcome  
Outcome  TimePoints 
Effectiveness against specific pathogens (e.g., Enterococcus faecalis).  Baseline 1 week 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   20/03/2025 
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="0"
Months="2"
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 - 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 -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [daulat2112@gmail.com].

  6. For how long will this data be available start date provided 14-01-2025 and end date provided 06-11-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

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

Proposal Comparative Evaluation of Green Tea Polyphenols Triphala Morinda citrifolia and Sodium Hypochlorite as Intracanal Irrigants

Aim and Objectives

  • Aim To compare the effectiveness of green tea polyphenols  Triphala, Morinda citrifolia, and 5% sodium hypochlorite as intracanal irrigants in reducing bacterial load in infected root canals.
  • Objectives:
    1. Evaluate the microbial reduction capacity of each irrigant.
    2. Analyze post-irrigation bacterial colony counts.
    3. Assess the comparative antimicrobial efficiency of natural alternatives and a chemical standard.

Justification for Study

  • Preservation of primary dentition is essential for oral and skeletal development. Endodontic challenges in pediatric patients arise due to anatomical complexity and behavioral factors.
  • Sodium hypochlorite (NaOCl) remains the gold standard but is associated with toxicity and adverse effects. Alternatives like green tea polyphenols Triphala and Morinda citrifolia offer comparable antimicrobial properties with biocompatibility safety and eco-friendliness making them suitable for pediatric use.

Methodology

Study Design: Interventional study conducted at KGMU Departments of Pediatric Dentistry and Microbiology.
Sample Size: 64 participants (16 in each group).
Duration: 6 months.

  1. Participants:

    • Inclusion: 5-9 years, non-vital pulp localized infection and radiographic evidence of periapical radiolucency.
    • Exclusion: Advanced root resorption uncooperative behavior and unrestorable teeth.

  2. Intervention Protocol:

    • Pre- and post-irrigation microbial samples collected using sterile paper points.
    • Irrigation with:
      • Group 1: Green tea polyphenols solution.
      • Group 2: Triphala decoction.
      • Group 3: Morinda citrifolia juice (MCJ).
      • Control: 5% Sodium hypochlorite.

  3. Outcome Measures:

    • Primary: Reduction in bacterial load  measured as CFUs before and after irrigation.
    • Secondary: Effectiveness against specific pathogens (e.g., Enterococcus faecalis).

  4. Statistical Analysis:

    • Data will be analyzed using ANOVA for group comparisons and paired t-tests for intra-group reductions. Significance set at p < 0.05.

Potential Risks and Benefits

  • Risks: Minimal, including minor discomfort during sampling. Natural irrigants are safe and non-toxic.
  • Benefits: Exploration of safer, cost-effective, and efficient irrigants to replace toxic chemical options.

National Significance

  • The study aligns with the global push for biocompatible and eco-friendly dental materials.
  • Findings could influence pediatric endodontic protocols in India, promoting herbal alternatives and reducing reliance on sodium hypochlorite thus improving patient compliance and safety
 
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