An Early Phase 1 interventional study of Sodium hypochlorite 3% and Frankincense-based irrigant in Pulp Necrosis, Root Canal Infection and Apical Periodontitis, sponsored by Oman Dental College. Not yet recruiting at 1 site in Oman. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Oman Dental College · Early Phase 1, Interventional, and Treatment
This research study is being done to find out if a natural ingredient called frankincense can clean infected root canals as effectively as the standard cleaning solution currently used in dentistry.
When a tooth's nerve dies from infection, dentists use a strong cleaning liquid, called sodium hypochlorite, to kill bacteria inside the tooth before filling it. This liquid works well, but it can sometimes irritate the gums or taste unpleasant. Frankincense, a natural substance long used in Oman, has shown early signs in laboratory studies that it may also fight bacteria effectively, with fewer side effects.
In this study, patients needing root canal treatment for an infected, dead tooth will be randomly placed into one of two groups. One group will have their tooth cleaned with the standard liquid. The other group will have their tooth cleaned with the frankincense-based liquid. Before and after cleaning, a small, painless sample will be taken from inside the tooth to measure how much bacteria is present, using a lab test called PCR. The results from both groups will then be compared to see which cleaning liquid removes more bacteria.
Patients who are between 18 and 50 years old, and who need root canal treatment for a dead/infected tooth, may be able to join. The study involves no extra visits beyond normal root canal treatment.
This is a single-center, randomized, active-controlled clinical trial evaluating a standardized frankincense-based intracanal irrigant compared with 3% sodium hypochlorite (NaOCl) in patients with pulpal necrosis, conducted at Oman Dental College.
Eligible participants are adults aged 18-50 years diagnosed with pulpal necrosis (single- or multi-rooted teeth), with or without apical periodontitis. Exclusion criteria include periodontal pockets greater than 4 mm, calcified canals, acute apical abscess, internal resorption, open apex, retreatment cases, antibiotic therapy within the prior 3 months, pregnancy, and systemic comorbidities.
Thirty root canals will be enrolled and allocated 1:1 to two groups using block randomization: Group A (control) will receive standard 3% NaOCl, and Group B (intervention) will receive a standardized frankincense-based irrigant. Both irrigants will be delivered using the same standardized volume (approximately 5 mL) and activation time (30-60 seconds) to ensure the only planned difference between groups is the irrigant itself.
A pre-irrigation microbial sample will be collected from each canal using a sterile paper point, followed by irrigation with the assigned solution, and then a post-irrigation sample. Samples will be analyzed by quantitative real-time PCR (qPCR) for total bacterial load (universal 16S rRNA) and for Enterococcus faecalis specifically. Laboratory personnel performing the qPCR analysis, and the statistician analyzing the data, will be blinded to group allocation using coded sample identifiers.
The primary outcome is the log10 reduction in total bacterial load from pre- to post-irrigation. Secondary outcomes include the percentage reduction in bacterial load between groups, the reduction in E. faecalis counts, and adverse events (e.g., tissue irritation, discomfort). Statistical analysis will use paired t-tests or Wilcoxon signed-rank tests for within-group comparisons, and independent t-tests or Mann-Whitney U tests for between-group comparisons, with significance set at p\<0.05
156 studies on the registry are indexed under Dental Pulp Necrosis; 43 are open to participants now.
This study's planned enrollment of 30 is below the median of 45 across 147 interventional studies indexed under Dental Pulp Necrosis.
Browse Dental Pulp Necrosis studies →Oman Dental College is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Participants randomized to this arm will receive standard 3% sodium hypochlorite (NaOCl) irrigation, the clinic's current standard-of-care irrigant, prepared according to institutional protocol. Approximately 5 mL of irrigant will be delivered per canal, with 30-60 seconds of activation (manual dynamic or sonic agitation), following standardized access, minimal instrumentation, and pre-irrigation microbiological sampling. A post-irrigation sample will be taken via sterile paper point immediately after irrigation.
Drug: Sodium hypochlorite 3%
Participants randomized to this arm will receive a standardized frankincense-based irrigant (Boswellia sacra-derived extract), formulated at a fixed concentration and pH, with batch sterility and endotoxin testing and stability/compatibility testing completed prior to clinical use. Approximately 5 mL of irrigant will be delivered per canal, with 30-60 seconds of activation (manual dynamic or sonic agitation, final protocol to be fixed prior to trial start), using the same standardized volume, activation method, and contact time as the control arm, following standardized access, minimal instrumentation, and pre-irrigation microbiological sampling. A post-irrigation sample will be taken via sterile paper point immediately after irrigation.
Drug: Frankincense-based irrigant
Standard-of-care root canal irrigant used as the active comparator. A 3% aqueous sodium hypochlorite solution, prepared per institutional protocol, delivered at approximately 5 mL per canal with 30-60 seconds of activation (manual dynamic or sonic agitation).
Also known as: NaOCl 3%
Investigational root canal irrigant consisting of a standardized Boswellia sacra (frankincense) extract formulation, adjusted to a fixed concentration and pH, with batch sterility and endotoxin testing and stability/compatibility testing completed prior to clinical use. Delivered at approximately 5 mL per canal with 30-60 seconds of activation (manual dynamic or sonic agitation), matching the control arm's volume, activation method, and contact time so that the irrigant itself is the only planned difference between groups.
Reduction in Total Bacterial Load
The change in total endodontic bacterial load, measured by quantitative real-time PCR (qPCR) targeting the universal 16S rRNA gene, calculated as log10(pre-irrigation bacterial load) minus log10(post-irrigation bacterial load). Assessed and compared between the frankincense-based irrigant group and the 3% NaOCl group.
Time frame: 1 hour. First sample will be taken pre-intervention/procedural (before chemo-mechanical preparation) and the second sample will be taken immediately after the intervention (after completion of chemo-mechanical preparation) in the same clinical visit.
Percentage Reduction in Total Bacterial Load Between Groups
Comparison of the percentage reduction in total bacterial load (16S rRNA qPCR) between the frankincense-based irrigant group and the 3% NaOCl group. Time Frame: Within a single clinical visit; pre- to post-irrigation
Time frame: This can be also referred to as Pre-procedural and post-procedural; the procedure being pulp extirpation followed by irrigation, cleaning and shaping of the rootcanals, within a single clinical visit; 1 hour. Pre-intervention & post-intervention samples
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Data privacy of the patients. Patient data privacy is essential in dentistry to protect sensitive personal and medical information from unauthorized access or misuse. Dental professionals handle records such as medical histories, treatment plans, and personal details, making confidentiality a key responsibility. Information should only be accessed by authorized staff and shared only with patient consent or legal obligation. With digital records, strong security measures are vital, including encryption, secure systems, and controlled access. Regular staff training helps prevent data breaches and accidental disclosure. Legal frameworks such as HIPAA and GDPR ensure that patient information is handled responsibly and securely.Patients also have rights to access, review, and request corrections to their data, promoting transparency and trust. Overall, maintaining data privacy ensures ethical practice and strengthens patient confidence in us.
Start is estimated for Jan 2027; primary completion for Dec 2027, 10 months later.
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Oman Dental College