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Clinical Trials/CTRI/2025/02/081258
CTRI/2025/02/081258
Not yet recruiting
Not Applicable

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

Dr Daulat Kumar1 site in 1 country64 target enrollmentStarted: March 20, 2025Last updated:
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Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Dr Daulat Kumar
Enrollment
64
Locations
1
Primary Endpoint
Colony-Forming Units (CFUs):
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.
  1. 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.
  1. Outcome Measures:
  • Primary: Reduction in bacterial load  measured as CFUs before and after irrigation.
  • Secondary: Effectiveness against specific pathogens (e.g., Enterococcus faecalis).
  1. 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

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
5.00 Year(s) to 9.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •Presence of advanced physiologic or pathologic root resorption in X-ray.
  • •Uncooperative children.
  • •Teeth with unrestorable crowns.
  • •Teeth with abnormal anatomy and calcified canals.

Outcomes

Primary Outcomes

Colony-Forming Units (CFUs):

Time Frame: baseline , 1 week

Quantification of the number of CFUs obtained from pre- and post-irrigation microbial samples using appropriate culture techniques.

Time Frame: baseline , 1 week

Secondary Outcomes

  • Effectiveness against specific pathogens (e.g., Enterococcus faecalis).(Baseline 1 week)

Investigators

Sponsor
Dr Daulat Kumar
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Daulat Kumar

Faculty of dental sciences king george medical university

Study Sites (1)

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