Frankincense Versus Sodium Hypochlorite for Root Canal Disinfection

NCT07823868 | Not Yet Recruiting Early Phase 1

• 1 other identifier: ODC\Res\2026\000014
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulp Necrosis; Root Canal Infection; Apical Periodontitis

Keywords

randomized control trial; Frankinscence endoodontic irrigant

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  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

Study Arms (2)

3% Sodium Hypochlorite (Control)

ACTIVE COMPARATOR

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%

Frankincense-Based Herbal Irrigant (Intervention)

EXPERIMENTAL

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

Interventions

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).

Also known as: NaOCl 3%

3% Sodium Hypochlorite (Control)

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.

Frankincense-Based Herbal Irrigant (Intervention)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oman Dental College: lead
• IMU University, Malaysia: collaborator
• Sultan Qaboos University: collaborator

Study Sites (1)

Oman dental college

Muscat, 111, Oman

Location

Related Publications (10)

• Gutmann JL, Manjarres V. Historical and Contemporary Perspectives on the Microbiological Aspects of Endodontics. Dent J (Basel). 2018 Sep 22;6(4):49. doi: 10.3390/dj6040049.

  PMID: 30249009 BACKGROUND

• Palwankar D, Garg A, Tandan M, Bhasin P, Sachdeva A, Palwankar P. Antimicrobial efficacy of two commercially available herbal products with and without ultrasonic activation in primary endodontic infections: A randomized clinical trial. J Conserv Dent Endod. 2024 Mar;27(3):305-309. doi: 10.4103/JCDE.JCDE_308_23. Epub 2024 Mar 6.

  PMID: 38634027 BACKGROUND

• Das A, et al. Comparative evaluation of herbal irrigants on root canal microflora: a clinical study. J Conserv Dent. 2024;27(2):120-126.

  BACKGROUND

• Almohareb RA, et al. Antibacterial efficacy of frankincense extract against Enterococcus faecalis: an in vitro study. Saudi Dent J. 2025;37(1):45-52.

  BACKGROUND

• Di Stefano M, et al. Chemical composition and antimicrobial activity of Boswellia sacra essential oils. Microorganisms. 2020;8(6):984.

  BACKGROUND

• Abushouk S, Lundy F, Linden G, Abdel Hamid MM, Ibrahim Y, El Karim I. Quantitative Analysis of Candidate Endodontic Pathogens and Their Association with Cause and Symptoms of Apical Periodontitis in a Sudanese Population. Eur Endod J. 2021 Apr;6(1):50-55. doi: 10.14744/eej.2020.52297. Epub 2021 Mar 3.

  PMID: 33762533 BACKGROUND

• Zhang D, Shen Y, de la Fuente-Nunez C, Haapasalo M. In vitro evaluation by quantitative real-time PCR and culturing of the effectiveness of disinfection of multispecies biofilms in root canals by two irrigation systems. Clin Oral Investig. 2019 Feb;23(2):913-920. doi: 10.1007/s00784-018-2515-x. Epub 2018 Jun 15.

  PMID: 29948281 BACKGROUND

• Swimberghe RCD, Coenye T, De Moor RJG, Meire MA. Biofilm model systems for root canal disinfection: a literature review. Int Endod J. 2019 May;52(5):604-628. doi: 10.1111/iej.13050. Epub 2018 Dec 20.

  PMID: 30488449 BACKGROUND

• Siqueira JF Jr, Rocas IN. Present status and future directions: Microbiology of endodontic infections. Int Endod J. 2022 May;55 Suppl 3:512-530. doi: 10.1111/iej.13677. Epub 2022 Jan 13.

  PMID: 34958494 BACKGROUND

• Cai C, Chen X, Li Y, Jiang Q. Advances in the Role of Sodium Hypochlorite Irrigant in Chemical Preparation of Root Canal Treatment. Biomed Res Int. 2023 Jan 13;2023:8858283. doi: 10.1155/2023/8858283. eCollection 2023.

  PMID: 36685672 BACKGROUND

MeSH Terms

Conditions

Dental Pulp Necrosis; Periapical Periodontitis

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Periapical Diseases; Jaw Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Study Officials

• Triveni Mohan Nalawade

  Oman Dental College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Triveni Mohan Nalawade, PhD

CONTACT

91990834; tnalawade@staff.odc.edu.om

Ayida Al Wahaibi, PhD

CONTACT

24665555; aalwohaibi@Staff.odc.edu.om

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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."
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 16, 2026
• Study Start (Estimated): January 19, 2027
• Primary Completion (Estimated): December 7, 2027
• Study Completion (Estimated): May 7, 2028
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

OM (1)