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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Punjab Dental Hospital, Lahore | Lahore | Punjab Province | 54000 | Pakistan |
Undecided Confidentiality
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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
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| 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. |
|
| ID | Term |
|---|---|
| D003790 | Dental Pulp Necrosis |
| D010485 | Periapical Periodontitis |
| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010483 | Periapical Diseases |
| D007571 | Jaw Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D010518 | Periodontitis |
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| ID | Term |
|---|---|
| D012973 | Sodium Hypochlorite |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D006997 | Hypochlorous Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D017670 | Sodium Compounds |
| D004364 | Pharmaceutical Preparations |
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