Skip to content

Frankincense Versus Sodium Hypochlorite for Root Canal Disinfection

Antibacterial Effectiveness of Frankincense-Based Herbal Irrigant Against Endodontic Microflora Using Real-Time PCR - A Randomized Clinical Trial

Status
Not yet recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07823868
Acronym
FSHRCD: RCT
Enrollment
30
Registered
2026-09-16
Start date
2027-01-19
Completion date
2028-05-07
Last updated
2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apical Periodontitis, Pulp Necrosis, Root Canal Infection

Keywords

randomized control trial, Frankinscence endoodontic irrigant

Brief summary

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.

Detailed description

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

Interventions

DRUGSodium hypochlorite 3%

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).

DRUGFrankincense-based irrigant

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.

Sponsors

Oman Dental College
Lead SponsorOTHER
IMU University, Malaysia
CollaboratorOTHER
Sultan Qaboos University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

Laboratory personnel performing qPCR analysis and the data analyst are blinded to group allocation via coded study/sample identifiers. The allocation key is held by an independent study coordinator/statistician not involved in clinical procedures and released only after data lock. Clinicians and participants cannot be blinded due to visible/olfactory differences between irrigants."

Intervention model description

Two parallel groups receiving different root canal irrigants (3% NaOCl vs. frankincense-based irrigant) within a single clinical visit, with randomization occurring immediately prior to irrigation

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Reduction in Total Bacterial Load1 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.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.
Percentage Reduction in Total Bacterial Load Between GroupsThis 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 samplesComparison 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

Countries

Oman

Contacts

CONTACTTriveni Mohan Nalawade, PhD
tnalawade@staff.odc.edu.om91990834
CONTACTAyida Al Wahaibi, PhD
aalwohaibi@Staff.odc.edu.om24665555
PRINCIPAL_INVESTIGATORTriveni Mohan Nalawade

Oman Dental College

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 17, 2026