Pulp Necrosis, Apical PeriodontitisNCT07688005
Comparing Amla (Emblica Officinalis) and 3% Sodium Hypochlorite Against Enterococcus Faecalis in Root Canal Treatment.
A study testing Sodium Hypochlorite 3% Solution and Emblica officinalis Solution in people with Pulp Necrosis, Apical Periodontitis, run by Postgraduate Medical Institute, Lahore at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Pulp Necrosis, Apical Periodontitis
- What is being tested?
- Sodium Hypochlorite 3% Solution and Emblica officinalis Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 sitePakistan
- Study dates
- 17 Sep 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- ●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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pulp Necrosis, Apical Periodontitis
- Being tested
- Sodium Hypochlorite 3% Solution, Emblica officinalis Solution
- Keywords
- Colony-Forming Units (CFU/mL), root canal treatment, enterococcus faecalis, sodium hypochlorite, Emblica officinalis, root canal irrigation, root canal irrigant
- Medical subject headings
- Dental Pulp Necrosis, Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Hypochlorite 3% SolutionDrug
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 SolutionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Emblica officinalis Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, immediately after irrigation, and 7 days after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start17 Sep 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulp Necrosis, Apical PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Medical Institute, Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Afshan Afzal Wahla, Postgraduate Medical Institute, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07688005
- Sponsor's protocol ID
- AMC/PGMI/LGH/synopNO/00/217/22
- Status last verified
- Sep 2026
- First submitted
- 30 Jun 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Undecided Confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07688005
- Acronym / sponsor ID
- AMC/PGMI/LGH/synopNO/00/217/22
- Conditions
- Pulp Necrosis, Apical Periodontitis
- Keywords
- Colony-Forming Units (CFU/mL), root canal treatment, enterococcus faecalis, sodium hypochlorite, Emblica officinalis, root canal irrigation, root canal irrigant
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Postgraduate Medical Institute, LahoreUniversity, hospital or other
- Study start
- 17 Sep 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| 3% Sodium Hypochlorite Irrigation ( Control) | Active comparator | Drug: Sodium Hypochlorite 3% SolutionParticipants 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 | Drug: Emblica officinalis SolutionParticipants 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- ●Patients with ASA Classification III, IV, V and VI or any other congenital disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium Hypochlorite 3% SolutionA 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. | Drug | 3% Sodium Hypochlorite Irrigation ( Control) |
| Emblica officinalis SolutionA 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. | Drug | Emblica officinalis (Amla) Irrigation (Experimental) |
Primary outcome
Reduction in Enterococcus faecalis bacterial count (CFU/mL)
Time frame: Baseline, immediately after irrigation, and 7 days after treatment.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No. Undecided Confidentiality
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Hypochlorite 3% Solution and Emblica officinalis Solution in people with Pulp Necrosis, Apical Periodontitis, run by Postgraduate Medical Institute, Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Afshan Afzal Wahla Principal investigator, BDS (+ 923174226549, drafshanafzalwahla@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Enterococcus faecalis bacterial count (CFU/mL) (time frame: Baseline, immediately after irrigation, and 7 days after treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.