Antibacterial Effectiveness of Frankincense-Based Herbal Irrigant Against Endodontic Microflora Using Real-Time PCR - A Randomized Clinical Trial
| Registry | NCT07823868, acronym FSHRCD: RCT |
|---|---|
| Status | Not yet recruiting |
| Phase | Early Phase 1 |
| Study type | Interventional; randomized, parallel, masking: triple, treatment |
| Enrollment | 30 (Estimated) |
| Sponsor | Oman Dental College (Other); collaborators: IMU University, Malaysia, Sultan Qaboos University |
| Conditions | Pulp Necrosis, Root Canal Infection, Apical Periodontitis |
| Interventions | Sodium hypochlorite 3%, Frankincense-based irrigant (Drug) |
| Dates | start 2027-01-19 (estimated), primary completion 2027-12-07 (estimated), completion 2028-05-07 (estimated), first posted 2026-09-16, last updated 2026-09-22 |
| Locations | 1 site in Oman |
Related Papers Related Patents Related Grants Related Experts
All trials for Pulp Necrosis All trials for Root Canal Infection All trials of Sodium hypochlorite 3% All trials of Frankincense-based irrigant
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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 3% Sodium Hypochlorite (Control) | Active comparator | Drug: Sodium hypochlorite 3% | 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. |
| Frankincense-Based Herbal Irrigant (Intervention) | Experimental | Drug: Frankincense-based irrigant | 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. |
Sex: All, ages: 18 Years to 50 Years
Inclusion Criteria: * Age 18-50 years * Diagnosis of pulpal necrosis (single- or multi-rooted tooth), with or without apical periodontitis * Tooth suitable for standard endodontic access and microbiological sampling Exclusion Criteria: * Periodontal pockets >4 mm * Calcified canals * Acute apical abscess * Internal resorption * Open apex * Retreatment cases * Antibiotic/ herbal therapy within the prior 3 months * Pregnancy * Systemic comorbidities
| Facility | City | Country | Status |
|---|---|---|---|
| Oman dental college | Muscat | Oman |