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

NCT07688005 | Not Yet Recruiting DMC

• 1 other identifier: AMC/PGMI/LGH/synopNO/00/217/22
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulp Necrosis, Apical Periodontitis

Keywords

Enterococcus faecalis Root Canal Treatment Sodium Hypochlorite Emblica officinalis (Amla) Root Canal Irrigants; Colony-Forming Units (CFU/mL)

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

3% Sodium Hypochlorite Irrigation ( Control)

ACTIVE COMPARATOR

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

Emblica officinalis (Amla) Irrigation (Experimental)

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

Interventions

Sodium Hypochlorite 3% Solution DRUG

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.

3% Sodium Hypochlorite Irrigation ( Control)

Emblica officinalis Solution DRUG

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.

Emblica officinalis (Amla) Irrigation (Experimental)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• ●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.

Sponsors & Collaborators

• Postgraduate Medical Institute, Lahore: lead

Study Sites (1)

Punjab Dental Hospital, Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Dental Pulp Necrosis; Periapical Periodontitis

Interventions

Sodium Hypochlorite; Solutions

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Periapical Diseases; Jaw Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Hypochlorous Acid; Chlorine Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Sodium Compounds; Pharmaceutical Preparations

Central Study Contacts

Dr Afshan Afzal Wahla Principal investigator, BDS

CONTACT

+ 923174226549; drafshanafzalwahla@gmail.com

Dr shazia naz shazia naz, BDS, MDS

CONTACT

+923214614543; drshazianaz@demontmorency.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are randomly assigned to one of two intervention groups, and each participant receives only one of the study interventions throughout the trial: Group A (Control): 3% Sodium Hypochlorite irrigation Group B (Experimental): Emblica officinalis irrigation The groups are treated simultaneously, and outcomes are compared between them

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 7, 2026
• Study Start: July 1, 2026
• Primary Completion: August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)