Herbal Irrigation in Necrotic Primary MolarsNCT06969989
Herbal Irrigation in Necrotic Primary Molars
A study testing 10 % water extract of Boswellia Sacra, 1 % Sodium Hypochlorite and 0.9 % Normal Saline in people with Herbal Irrigation in Necrotic Primary Molars, run by Cairo University at 1 site in Egypt.
Trial summary
Frankincense is one of the herbal products that was traditionally used in folk medicine in many cultures due to its antibacterial, analgesic, and anti-inflammatory characteristics .In recent studies, practitioners have started using Frankincense as an intracanal irrigant in permanent teeth, comparing it with the gold… Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Herbal Irrigation in Necrotic Primary Molars
- What is being tested?
- 10 % water extract of Boswellia Sacra, 1 % Sodium Hypochlorite and 0.9 % Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2025to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Mandibular primary molars with deep caries and necrotic pulp.
- Mobility independent from normal physiological exfoliation
- Pain on percussion.
- Presence of fistula or furcation abscess.
- Restorable tooth
- Radiolucency in periapical or furcation area.
- Widening of PDL space or loss of lamina dura continuity.
- At least 2/3 root is present
Who cannot join
- Uncooperative children to avoid time waste and attrition bias.
- Children with systemic disease as some systemic diseases may affect the outcome.
- Lack of informed consent by the child patient's parent to be approved ethically.
- Refusal of participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Reem Mohammed Wahby, Lecturer of Pediatric Dentistr contact
Egypt1 site
Pediatric Dentistry and Dental Public Health Department - Faculty of Dentistry, Cairo University - Egypt.
Cairo, El Manial
About this study
Official title: Effectiveness of Boswellia Sacra Extract Compared to Sodium Hypochlorite and Saline as Root Canal Irrigants in Pulpectomy of Necrotic Primary Molars: A Randomized Clinical Study
Frankincense is one of the herbal products that was traditionally used in folk medicine in many cultures due to its antibacterial, analgesic, and anti-inflammatory characteristics .In recent studies, practitioners have started using Frankincense as an intracanal irrigant in permanent teeth, comparing it with the gold standard sodium hypochlorite. Based on the current knowledge, no clinical trials in literature have been performed to compare the effectiveness of Boswellia Sacra water extract versus sodium hypochlorite as a root canal irrigant in pulpectomy of necrotic primary molars.
Read the detailed description
Maintaining a healthy primary dentition is necessary for the proper development of the successors. Dental caries with pulpal involvement is one of the most widespread communicable diseases in children. Thus, in some instances, a pulpectomy procedure is essential to save the deciduous tooth from early extraction. As a result of the complex anatomy of root morphology and wide, apical foramen, a safe, potent irrigant is necessary to help disinfect the root canal system without harming the periapical tissues and the permanent tooth bud. Pulpectomy of primary teeth is indicated when the pulp tissue is irreversibly infected or necrotic due to caries or trauma. The treatment consists of extirpation of the pulp tissue, removal of organic debris with filing, and obturation of the canals with a suitable material .
The cleaning and shaping of the root canal process depends on a chemo-mechanical disinfection procedure, mechanically through canal shaping aiming to remove inflamed \& necrotic pulps tissues and infected debris from the root canal system, and chemically by the use of chemical antibacterial irrigants to disinfect the root canals and cause an aggressive decrease in the bacterial load inside the root canal system . Effective irrigant delivery is a prerequisite to root canal disinfection and debris removal to Improve endodontic treatment outcomes. Several irrigation agents have been developed in response to chemical disinfection. However, sodium hypochlorite (NaOCl) remains the irrigant of choice due to its antibacterial nature, dissolving both necrotic and organic matter within the smear layer.
Preventing post-endodontic pain is essential for both patients and clinicians. Postoperative pain is common after root canal treatment. It is mainly attributed to mechanical, chemical, and microbiological factors, especially in teeth with nonvital pulps, usually occurring due to the extrusion of infected debris and fluids.
Microorganisms and their metabolites are intimately related to the etiology of pulp and periapical pathology. The removal/elimination of pulp remnants, microorganisms, and byproducts is important for endodontic treatment success. Lipopolysaccharide (LPS), generally referred to as endotoxin, is present in the outer cell membranes of Gram-negative bacteria and is released during cell division or cell death, being one of the most important virulence factors involved in the development and maintenance of periapical inflammation and clinical symptomatology. Special attention has been given to the complete removal/neutralization of endotoxin from infected root canals The direction towards the usage of herbal products has gained great attention in recent years. The advantages they offer make them regarded as promising substitutions for synthetic chemical agents. Different essential oils with various purposes have been discovered and used for about 43 species of Boswellia. Boswellia sacra, one of the frankincense family, has been recommended to cure wounds, sores, and ulcers. In addition. Frankincense water extract has been utilized by ArabAfrican and Middle Eastern nations to alleviate cough, sore throat, and different gastrointestinal problems.
The Omani Luban, Oleo-Gum Resin of Boswellia sacra Flueck have been tested via in vitro studies showing antibacterial efficiency for its essential oils. Another research declared its promising chelating property in comparison to 17 % EDTA when used as an intracanal irrigant. Furthermore, another study revealed the regenerating power of boswellic acids for bone healing after endodontic surgeries.
- Being tested
- 10 % water extract of Boswellia Sacra, 1 % Sodium Hypochlorite, 0.9 % Normal Saline
- Keywords
- herbal irrigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 % water extract of Boswellia SacraOther
Canal shaping will be done using and rotary files with aid of 10 mL of the tested irrigant( 10 % water extract of Boswellia sacra) for lubrication, flushing of debris and canal disinfection via a plastic disposable syringe with a 30-gauge side vented needle will be used 2mm short from the working length
1 % Sodium HypochloriteOther
Canal shaping will be done using and rotary files with aid of 10 mL of the tested irrigant ( 1 % NaOCl ) for lubrication, flushing of debris and canal disinfection via a plastic disposable syringe with a 30-gauge side vented needle will be used 2mm short from the working length
0.9 % Normal SalineOther
Canal shaping will be done using and rotary files with aid of 10 mL of the tested irrigant (0.9 % saline) for lubrication, flushing of debris and canal disinfection via a plastic disposable syringe with a 30-gauge side vented needle will be used 2mm short from the working length
| Study group | Role | What they receive |
|---|---|---|
| 10 % water extract of Boswellia Sacra | Experimental | Canal shaping will be done using and rotary files then 10 mL of the tested irrigant( 10 % water extract of Boswellia Sacra) will be used for lubrication, flushing of debris and canal disinfection via a plastic disposable syringe with a 30-gauge side vented needle will be used 2mm short from the working length. Receives: Other: 10 % water extract of Boswellia Sacra |
| 1 % Sodium Hypochlorite | Active comparator | Canal shaping will be done using rotary files and 10 mL of the tested irrigant ( 1% NAOCL) will be used for lubrication, flushing of debris and canal disinfection via a plastic disposable syringe with a 30-gauge side vented needle will be used 2mm short from the working length. Receives: Other: 1 % Sodium Hypochlorite |
| 0.9 % saline | Placebo comparator | Canal shaping will be done using rotary files and 10 mL of the tested irrigant ( 0.9 % saline)will be used for lubrication, flushing of debris and canal disinfection via a plastic disposable syringe with a 30-gauge side vented needle will be used 2mmshort from the working length. Receives: Other: 0.9 % Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain
Visual Analog Pain Rating Scale will be explained to the children, and preoperative pain scores will be recorded. After completion post operative pain scores will be recorded as follows ( 6 / 12 / 24 hours )after the procedure.
Visual Analog Pain Rating Scale with scores Categorical(0-10) - 0 no pain - 1-3 mild pain - 4-6 moderate pain - 7-10 severe pain.
Measured: Records will be taken before the procedure then ( 6/ 12/ 24 hours) post procedure completion
Secondary outcomes (2)
Bacterial count measure
Microbiological analysis by aerobic and anaerobic bacterial culture. A Pre-preparation sample (S1) will be taken from the root canal just after the tooth is accessed. Three sterile paper points (size 15) will be introduced in the largest canal 1mm shorter than the working length predetermined by the apex locator. The paper points will be left in the canal for at least one minute, then transferred to a sterile Eppendorf tube containing the transfer media Brain heart infusion (BHI) broth, placed in an ice box and transferred for culture.
Post-instrumentation samples (s2) will be taken with three sterile paper points (size 15) introduced in the largest canal 1mm shorter than the working length which predetermined by the apex locator. The paper points will be left in the canal for for at least one minute, then transferred to a sterile Eppendorf tube containing the transfer media Brain heart (BHI) broth, placed in an ice box and transferred for culture.
Measured: S1 sample will be taken before chemo-mechanical preparation post access cavity . s2 samplewill be taken during the procedure immediately post completion of chemo-mechanical preparation
Amount of endotoxins
The three sterile paper points (size 15) will be introduced in the largest canal 1mm shorter than the working length predetermined by the apex locator. The paper points will be left in the canal for at least one minute then placed in a sterile empty Eppendorf tube for further Enzyme-linked immunosorbent assay (ELISA) to determine the number of endotoxins.
Post-instrumentation samples (s2) will be taken as previously described for (s1).Three sterile paper points (size 15) will be introduced in the largest canal 1mm shorter than the working length predetermined by the apex locator. The paper points will be left in the canal for at least one minute then placed in a sterile empty Eppendorf tube for further Enzyme-linked immunosorbent assay (ELISA) to determine the number of endotoxins.
Measured: S1 sample will be taken before chemo-mechanical preparation after access cavity is done . s2 sample will be taken during the procedure immediately post the completion of chemo-mechanical preparation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start1 Jul 2025 (estimated)
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herbal Irrigation in Necrotic Primary MolarsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Frankincense is one of the herbal products that was traditionally used in folk medicine in many cultures due to its antibacterial, analgesic, and anti-inflammatory characteristics. In recent studies, practitioners have started using Frankincense as an intracanal irrigant in permanent teeth, comparing it with the gold standard sodium hypochlorite. Based on the current knowledge, no clinical trials in literature have been performed to compare the effectiveness of Boswellia Sacra water extract versus sodium hypochlorite as a root canal irrigant in pulpectomy of necrotic primary molars.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doha Essam El Gohary, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06969989
- Sponsor's protocol ID
- irrigation in primary molars
- Status last verified
- May 2025
- First submitted
- 1 May 2025
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD might be shared on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Boswellia Sacra Extract Compared to Sodium Hypochlorite and Saline as Root Canal Irrigants in Pulpectomy of Necrotic Primary Molars: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT06969989
- Acronym / sponsor ID
- irrigation in primary molars
- Keywords
- herbal irrigation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Frankincense is one of the herbal products that was traditionally used in folk medicine in many cultures due to its antibacterial, analgesic, and anti-inflammatory characteristics .In recent studies, practitioners have started using Frankincense as an intracanal irrigant in permanent teeth, comparing it with the gold standard sodium hypochlorite. Based on the current knowledge, no clinical trials in literature have been performed to compare the effectiveness of Boswellia Sacra water extract versus sodium hypochlorite as a root canal irrigant in pulpectomy of necrotic primary molars.
Detailed description
Maintaining a healthy primary dentition is necessary for the proper development of the successors. Dental caries with pulpal involvement is one of the most widespread communicable diseases in children. Thus, in some instances, a pulpectomy procedure is essential to save the deciduous tooth from early extraction. As a result of the complex anatomy of root morphology and wide, apical foramen, a safe, potent irrigant is necessary to help disinfect the root canal system without harming the periapical tissues and the permanent tooth bud. Pulpectomy of primary teeth is indicated when the pulp tissue is irreversibly infected or necrotic due to caries or trauma. The treatment consists of extirpation of the pulp tissue, removal of organic debris with filing, and obturation of the canals with a suitable material .
The cleaning and shaping of the root canal process depends on a chemo-mechanical disinfection procedure, mechanically through canal shaping aiming to remove inflamed \& necrotic pulps tissues and infected debris from the root canal system, and chemically by the use of chemical antibacterial irrigants to disinfect the root canals and cause an aggressive decrease in the bacterial load inside the root canal system . Effective irrigant delivery is a prerequisite to root canal disinfection and debris removal to Improve endodontic treatment outcomes. Several irrigation agents have been developed in response to chemical disinfection. However, sodium hypochlorite (NaOCl) remains the irrigant of choice due to its antibacterial nature, dissolving both necrotic and organic matter within the smear layer.
Preventing post-endodontic pain is essential for both patients and clinicians. Postoperative pain is common after root canal treatment. It is mainly attributed to mechanical, chemical, and microbiological factors, especially in teeth with nonvital pulps, usually occurring due to the extrusion of infected debris and fluids.
Microorganisms and their metabolites are intimately related to the etiology of pulp and periapical pathology. The removal/elimination of pulp remnants, microorganisms, and byproducts is important for endodontic treatment success. Lipopolysaccharide (LPS), generally referred to as endotoxin, is present in the outer cell membranes of Gram-negative bacteria and is released during cell division or cell death, being one of the most important virulence factors involved in the development and maintenance of periapical inflammation and clinical symptomatology. Special attention has been given to the complete removal/neutralization of endotoxin from infected root canals The direction towards the usage of herbal products has gained great attention in recent years. The advantages they offer make them regarded as promising substitutions for synthetic chemical agents. Different essential oils with various purposes have been discovered and used for about 43 species of Boswellia. Boswellia sacra, one of the frankincense family, has been recommended to cure wounds, sores, and ulcers. In addition. Frankincense water extract has been utilized by ArabAfrican and Middle Eastern nations to alleviate cough, sore throat, and different gastrointestinal problems.
The Omani Luban, Oleo-Gum Resin of Boswellia sacra Flueck have been tested via in vitro studies showing antibacterial efficiency for its essential oils. Another research declared its promising chelating property in comparison to 17 % EDTA when used as an intracanal irrigant. Furthermore, another study revealed the regenerating power of boswellic acids for bone healing after endodontic surgeries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Frankincense is one of the herbal products that was traditionally used in folk medicine in many cultures due to its antibacterial, analgesic, and anti-inflammatory characteristics. In recent studies, practitioners have started using Frankincense as an intracanal irrigant in permanent teeth, comparing it with the gold standard sodium hypochlorite. Based on the current knowledge, no clinical trials in literature have been performed to compare the effectiveness of Boswellia Sacra water extract versus sodium hypochlorite as a root canal irrigant in pulpectomy of necrotic primary molars.
| Arm | Type | Receives |
|---|---|---|
| 10 % water extract of Boswellia Sacra | Experimental | Other: 10 % water extract of Boswellia SacraCanal shaping will be done using and rotary files then 10 mL of the tested irrigant( 10 % water extract of Boswellia Sacra) will be used for lubrication, flushing of debris and canal disinfection via a plastic disposable syringe with a 30-gauge side vented needle will be used 2mm short from the working length. |
| 1 % Sodium Hypochlorite | Active comparator | Other: 1 % Sodium HypochloriteCanal shaping will be done using rotary files and 10 mL of the tested irrigant ( 1% NAOCL) will be used for lubrication, flushing of debris and canal disinfection via a plastic disposable syringe with a 30-gauge side vented needle will be used 2mm short from the working length. |
| 0.9 % saline | Placebo comparator | Other: 0.9 % Normal SalineCanal shaping will be done using rotary files and 10 mL of the tested irrigant ( 0.9 % saline)will be used for lubrication, flushing of debris and canal disinfection via a plastic disposable syringe with a 30-gauge side vented needle will be used 2mmshort from the working length. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Mandibular primary molars with deep caries and necrotic pulp.
- Mobility independent from normal physiological exfoliation
- Pain on percussion.
- Presence of fistula or furcation abscess.
- Restorable tooth
Key exclusion criteria (4 listed)
- Uncooperative children to avoid time waste and attrition bias.
- Children with systemic disease as some systemic diseases may affect the outcome.
- Lack of informed consent by the child patient's parent to be approved ethically.
- Refusal of participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10 % water extract of Boswellia SacraCanal shaping will be done using and rotary files with aid of 10 mL of the tested irrigant( 10 % water extract of Boswellia sacra) for lubrication, flushing of debris and canal disinfection via a plastic disposable syringe with a 30-gauge side vented needle will be used 2mm short from the working length | Other | 10 % water extract of Boswellia Sacra |
| 1 % Sodium HypochloriteCanal shaping will be done using and rotary files with aid of 10 mL of the tested irrigant ( 1 % NaOCl ) for lubrication, flushing of debris and canal disinfection via a plastic disposable syringe with a 30-gauge side vented needle will be used 2mm short from the working length | Other | 1 % Sodium Hypochlorite |
| 0.9 % Normal SalineCanal shaping will be done using and rotary files with aid of 10 mL of the tested irrigant (0.9 % saline) for lubrication, flushing of debris and canal disinfection via a plastic disposable syringe with a 30-gauge side vented needle will be used 2mm short from the working length | Other | 0.9 % saline |
Primary outcome
Post operative pain
Time frame: Records will be taken before the procedure then ( 6/ 12/ 24 hours) post procedure completion
Visual Analog Pain Rating Scale will be explained to the children, and preoperative pain scores will be recorded. After completion post operative pain scores will be recorded as follows ( 6 / 12 / 24 hours )after the procedure. Visual Analog Pain Rating Scale with scores Categorical(0-10) - 0 no pain - 1-3 mild pain - 4-6 moderate pain - 7-10 severe pain.
2 secondary outcomes
Bacterial count measure
Time frame: S1 sample will be taken before chemo-mechanical preparation post access cavity . s2 samplewill be taken during the procedure immediately post completion of chemo-mechanical preparation
Amount of endotoxins
Time frame: S1 sample will be taken before chemo-mechanical preparation after access cavity is done . s2 sample will be taken during the procedure immediately post the completion of chemo-mechanical preparation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: No. IPD might be shared on reasonable request
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Reem Mohammed Wahby, Lecturer of Pediatric Dentistr contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10 % water extract of Boswellia Sacra, 1 % Sodium Hypochlorite and 0.9 % Normal Saline in people with Herbal Irrigation in Necrotic Primary Molars, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Doha Essam El Gohary, Bachelor of science (+201119404444, doha.essam@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative pain (time frame: Records will be taken before the procedure then ( 6/ 12/ 24 hours) post procedure completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.