Pulp NecrosisEarly Phase 1FSHRCD: RCTNCT07823868
Frankincense Versus Sodium Hypochlorite for Root Canal Disinfection
A Early Phase 1 study testing Sodium hypochlorite 3% and Frankincense-based irrigant in people with Pulp Necrosis and Root Canal Infection, run by Oman Dental College at 1 site in Oman.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Pulp Necrosis, Root Canal Infection, Apical Periodontitis
- What is being tested?
- Sodium hypochlorite 3% and Frankincense-based irrigant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteOman
- Study dates
- 19 Jan 2027to 7 May 2028
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Periodontal pockets >4 mm
- Calcified canals
- Acute apical abscess
- Internal resorption
- Open apex
- Retreatment cases
Show all 9Show fewer
- Antibiotic/ herbal therapy within the prior 3 months
- Pregnancy
- Systemic comorbidities
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Antibacterial Effectiveness of Frankincense-Based Herbal Irrigant Against Endodontic Microflora Using Real-Time PCR - A Randomized Clinical 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.
Read more
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.
Read the 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
- Conditions
- Pulp Necrosis, Root Canal Infection, Apical Periodontitis
- Being tested
- Sodium hypochlorite 3%, Frankincense-based irrigant
- Keywords
- randomized control trial, Frankinscence endoodontic irrigant
- Medical subject headings
- Dental Pulp Necrosis, Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium hypochlorite 3%Drug
Also called NaOCl 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).
Frankincense-based irrigantDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Frankincense-based irrigant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start19 Jan 2027 (estimated)
- Primary completion7 Dec 2027 (estimated)
- Study completion7 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Pulp NecrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oman Dental College
- Sponsor type
- University, hospital or other
- Collaborators
- IMU University, Malaysia, Sultan Qaboos University
- Responsible party
- Sponsor
- Investigators
- Triveni Mohan Nalawade, Principal investigator, Oman Dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07823868
- Sponsor's protocol ID
- ODC\Res\2026\000014
- Acronym
- FSHRCD: RCT
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 30249009Palwankar 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.
PubMed 38634027Das A, et al. Comparative evaluation of herbal irrigants on root canal microflora: a clinical study. J Conserv Dent. 2024;27(2):120-126.
Almohareb RA, et al. Antibacterial efficacy of frankincense extract against Enterococcus faecalis: an in vitro study. Saudi Dent J. 2025;37(1):45-52.
Di Stefano M, et al. Chemical composition and antimicrobial activity of Boswellia sacra essential oils. Microorganisms. 2020;8(6):984.
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.
PubMed 33762533Zhang 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.
PubMed 29948281Swimberghe 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.
PubMed 30488449Siqueira 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.
PubMed 34958494Cai 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.
PubMed 36685672