Clinical trial NCT06969989: Herbal Irrigation in Necrotic Primary Molars
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Herbal Irrigation in Necrotic Primary Molars
Keywords: herbal irrigation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Post operative pain
timeFrame: Records will be taken before the procedure then ( 6/ 12/ 24 hours) post procedure completion
Secondary outcomes:
measure: Bacterial count measure
timeFrame: 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
measure: Amount of endotoxins
timeFrame: 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.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Pediatric Dentistry and Dental Public Health Department - Faculty of Dentistry, Cairo University - Egypt.
state: El Manial
Study officials:
References: