Comparing Amla (Emblica Officinalis) and 3% Sodium Hypochlorite Against Enterococcus Faecalis in Root Canal Treatment: A Randomized Controlled Trial

"Comparative Antibacterial Evaluation of Emblica Officinalis and 3% Sodium Hypochlorite, Against Enterococcus Faecalis, as Root Canal Irrigants in Non-surgical Root Canal Treatment of Mature Single Rooted Anterior Teeth - A Randomized Controlled Trial."

Bacteria inside the root canal are a major cause of tooth infections. If they are not completely removed, the infection may continue even after root canal treatment. One bacterium, Enterococcus faecalis, is commonly found in persistent root canal infections. The goal of root canal treatment is to remove these bacteria and prevent the infection from returning. Along with cleaning the canal using dental instruments, dentists use disinfecting solutions (called irrigants) to kill remaining bacteria.

The most commonly used irrigant is 3% sodium hypochlorite. Although it is effective at killing bacteria, it can irritate tissues, cause allergic reactions, has an unpleasant smell and taste, and may weaken the tooth. Because of these disadvantages, researchers are exploring safer natural alternatives. Amla (Emblica officinalis) is a medicinal plant known for its antibacterial, anti-inflammatory, and pain-relieving properties. This study aims to compare amla with 3% sodium hypochlorite to determine how well each reduces Enterococcus faecalis during root canal treatment and whether they produce similar clinical outcomes.

The study will include 66 patients aged 14-50 years who require root canal treatment for an infected single-rooted front tooth. Participants will be randomly assigned to one of two groups: one will receive 3% sodium hypochlorite, and the other will receive amla as the root canal irrigant. Bacterial samples will be collected before treatment, immediately after cleaning the canal, and one week later. The number of bacteria will be measured and compared between the two groups. The researchers will also assess pain, tenderness, and other signs of healing after treatment. The findings will help determine whether amla is a safe and effective natural alternative to the standard root canal irrigant.

Study Overview

• Status: Not yet recruiting
• Conditions: Pulp Necrosis, Apical Periodontitis
• Intervention / Treatment: Drug: Sodium Hypochlorite 3% Solution; Drug: Emblica officinalis Solution

Detailed Description

The primary objective of endodontic therapy is the complete elimination of microorganisms from the root canal system. Successful root canal treatment (RCT) depends on effective cleaning, shaping, and disinfection of the root canal system. During canal preparation, the removal of bacterial toxins and the smear layer is essential to minimize the microbial load. However, because bacteria and dentinal debris may remain within the complex anatomy of the root canal system, mechanical instrumentation alone is often insufficient to achieve complete disinfection. Elimination of the infection before obturation is critical for improving treatment success and promoting periapical healing.

Enterococcus faecalis is one of the microorganisms most frequently associated with persistent root canal infections and endodontic treatment failure. It is a facultative anaerobic, Gram-positive coccus capable of surviving under harsh environmental conditions. E. faecalis can persist in nutrient-deprived environments, exhibits resistance to several intracanal medicaments, and tolerates alkaline conditions with a pH of up to 11.5, making it particularly difficult to eradicate.

To enhance microbial elimination, root canal preparation is routinely supplemented with irrigating solutions. Sodium hypochlorite (NaOCl) is the most widely used endodontic irrigant because of its broad-spectrum antimicrobial activity and tissue-dissolving properties. It is commonly used in concentrations ranging from 0.5% to 5.25%. Although NaOCl is considered the gold standard irrigant, higher concentrations are associated with increased cytotoxicity, tissue irritation, and caustic effects. Accidental extrusion beyond the root apex may result in severe damage to the surrounding periodontal and periapical tissues.

In view of these limitations, there is growing interest in identifying natural irrigants that provide effective antimicrobial activity with fewer adverse effects. Emblica officinalis (Amla) is a medicinal plant with well-documented antibacterial, anti-inflammatory, antioxidant, and analgesic properties. It has been widely used in traditional medicine and is rich in vitamin C and other bioactive compounds. Several in vitro studies have demonstrated significant antibacterial activity of Emblica officinalis against Enterococcus faecalis. In addition, it is inexpensive, readily available, and has no reported toxicity when used appropriately.

The present randomized controlled trial aims to compare the antibacterial efficacy of Emblica officinalis with 3% sodium hypochlorite as root canal irrigants during non-surgical root canal treatment of mature single-rooted anterior teeth with pulp necrosis and apical periodontitis. Antibacterial efficacy will be assessed by measuring bacterial colony-forming units (CFU/mL), and clinical outcomes will be evaluated by assessing pain on percussion, tenderness on palpation, and the presence of a sinus tract following treatment.

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr Afshan Afzal Wahla Principal investigator, BDS; Phone Number: + 923174226549; Email: drafshanafzalwahla@gmail.com
• Study Contact Backup: Name: Dr shazia naz shazia naz, BDS, MDS; Phone Number: +923214614543; Email: drshazianaz@demontmorency.edu.pk

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, 54000
      • Punjab Dental Hospital, Lahore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Co-operative patients of both sexes aged between 18-50 years
• Patients belonging to ASA classification I and II (mild to moderate systemic disease).
• Permanent mature single-rooted and single canal teeth.
• Patients with pulp necrosis / apical periodontitis (primary endodontic infection with periapical radiolucency) will be included.
• Adequate crown structure.
• Probing level </= 3mm
• Patients not taking antibiotics for the last two weeks (pragmatic approach).

Exclusion Criteria:

• ●Patients with ASA Classification III, IV, V and VI or any other congenital disease.

  • Patient with liver failure and patient on blood thinning medication will be excluded.
  • Teeth with Multiple roots and canals.
  • Teeth with calcified pulp chamber.
  • Teeth with previous endodontic therapy performed.
  • Aberrant anatomy.
  • Teeth associated with vertical root fracture and coronal perforation.
  • Patient taking antibiotics in the last two weeks.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 3% Sodium Hypochlorite Irrigation ( Control); Participants assigned to this arm will undergo non-surgical root canal treatment using 3% sodium hypochlorite as the root canal irrigant. Following access cavity preparation and working length determination, the root canal will be instrumented using K-files. A total of 6 mL of 3% sodium hypochlorite will be used for irrigation during canal preparation and shaping. Microbiological samples will be collected before instrumentation (S1), immediately after instrumentation and irrigation (S2), and one week later (S3) to evaluate the reduction in Enterococcus faecalis colony-forming units (CFU/mL). Clinical outcomes, including pain on percussion, tenderness on palpation, and the presence of a sinus tract, will also be assessed.	Drug: Sodium Hypochlorite 3% Solution; A total of 6 mL of 3% sodium hypochlorite will be used as the root canal irrigant during cleaning and shaping in non-surgical root canal treatment.
Experimental: Emblica officinalis (Amla) Irrigation (Experimental); Participants assigned to this arm will undergo non-surgical root canal treatment using Emblica officinalis (Amla) as the root canal irrigant. Following access cavity preparation and working length determination, the root canal will be instrumented using K-files. A total of 6 mL of Emblica officinalis solution will be used for irrigation during canal preparation and shaping. Microbiological samples will be collected before instrumentation (S1), immediately after instrumentation and irrigation (S2), and one week later (S3) to evaluate the reduction in Enterococcus faecalis colony-forming units (CFU/mL). Clinical outcomes, including pain on percussion, tenderness on palpation, and the presence of a sinus tract, will also be assessed.	Drug: Emblica officinalis Solution; A total of 6 mL of Emblica officinalis (Amla) solution will be used as the root canal irrigant during cleaning and shaping in non-surgical root canal treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in Enterococcus faecalis bacterial count (CFU/mL)	Change in the number of Enterococcus faecalis colony-forming units (CFU/mL) recovered from root canal samples collected before treatment, immediately after irrigation, and 7 days after treatment, comparing 3% sodium hypochlorite and Emblica officinalis irrigation.	Baseline, immediately after irrigation, and 7 days after treatment.

Collaborators and Investigators

• Sponsor: Postgraduate Medical Institute, Lahore

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: June 30, 2026
• First Submitted That Met QC Criteria: June 30, 2026
• First Posted (Actual): July 7, 2026

Study Record Updates

• Last Update Posted (Actual): July 7, 2026
• Last Update Submitted That Met QC Criteria: June 30, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Enterococcus faecalis Root Canal Treatment Sodium Hypochlorite Emblica officinalis (Amla) Root Canal Irrigants; Colony-Forming Units (CFU/mL)
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Periapical Diseases; Jaw Diseases; Dental Pulp Diseases; Tooth Diseases; Necrosis; Periodontitis; Pathological Conditions, Signs and Symptoms; Periapical Periodontitis; Dental Pulp Necrosis; Pharmaceutical Preparations; Inorganic Chemicals; Chlorine Compounds; Oxides; Oxygen Compounds; Hypochlorous Acid; Sodium Compounds; Sodium Hypochlorite; Solutions
• Other Study ID Numbers: AMC/PGMI/LGH/synopNO/00/217/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Undecided Confidentiality

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No