Herbal Irrigation in Necrotic Primary Molars

NCT06969989 | Not Yet Recruiting DMC

• 1 other identifier: irrigation in primary molars
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Herbal Irrigation in Necrotic Primary Molars

Keywords

herbal irrigation

Outcome Measures

Primary Outcomes (1)

• 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.

  Records will be taken before the procedure then ( 6/ 12/ 24 hours) post procedure completion

Secondary Outcomes (2)

• Bacterial count measure

  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

  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.

Study Arms (3)

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.

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.

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.

Other: 0.9 % Normal Saline

Interventions

10 % water extract of Boswellia Sacra OTHER

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

10 % water extract of Boswellia Sacra

1 % Sodium Hypochlorite OTHER

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

1 % Sodium Hypochlorite

0.9 % Normal Saline OTHER

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

0.9 % saline

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Pediatric Dentistry and Dental Public Health Department - Faculty of Dentistry, Cairo University - Egypt.

Cairo, El Manial, Egypt

Location

MeSH Terms

Interventions

Sodium Hypochlorite; Saline Solution

Intervention Hierarchy (Ancestors)

Hypochlorous Acid; Chlorine Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Doha Essam El Gohary, Bachelor of science

CONTACT

+201119404444; doha.essam@dentistry.cu.edu.eg

Reem Mohammed Wahby, Lecturer of Pediatric Dentistr

CONTACT

+021122788078; reem.wahby@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: statisticians
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR

Model Details: 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.

Study Record Dates

• First Submitted: May 1, 2025
• First Posted: May 14, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)