Frankincense Versus Sodium Hypochlorite for Root Canal Disinfection

ConditionsPulp Necrosis Root Canal Infection Apical Periodontitis

Trial statusNot yet recruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

Age18-50

SponsorOman Dental College

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Periodontal pockets >4 mm

Calcified canals

Acute apical abscess

Internal resorption

Trial design

Design model

Parallel

Treatments tested in this trial

Sodium hypochlorite 3%
Drug
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).
Frankincense-based irrigant
Drug
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.

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: 3% Sodium Hypochlorite (Control)Active comparator 1 intervention

Group B: Frankincense-Based Herbal Irrigant (Intervention)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oman Dental College

Lead sponsor

IMU University, Malaysia

Collaborator

Sultan Qaboos University

Collaborator

Source ClinicalTrials.gov

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