Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2025-07-01
2026-08-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
DOUBLE
Study Groups
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10 % water extract of Boswellia Sacra
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.
10 % water extract of Boswellia Sacra
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 Hypochlorite
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.
1 % Sodium Hypochlorite
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 % saline
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.
0.9 % Normal Saline
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
Interventions
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10 % water extract of Boswellia Sacra
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 Hypochlorite
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 Saline
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
4 Years
7 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Doha Essam El Gohary
DR
Locations
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Pediatric Dentistry and Dental Public Health Department - Faculty of Dentistry, Cairo University - Egypt.
Cairo, El Manial, Egypt
Countries
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Central Contacts
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Other Identifiers
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irrigation in primary molars
Identifier Type: -
Identifier Source: org_study_id
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