Comparing Amla (Emblica Officinalis) and 3% Sodium Hypochlorite Against Enterococcus Faecalis in Root Canal Treatment.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorPostgraduate Medical Institute, Lahore

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

●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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: 3% Sodium Hypochlorite Irrigation ( Control)Active comparator 1 intervention
Group B: Emblica officinalis (Amla) Irrigation (Experimental)Experimental treatment 1 intervention

Trial outcomes

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.

Time frame
Baseline, immediately after irrigation, and 7 days after treatment.

Secondary outcomes

Other outcomes

Sponsors and contacts

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