Effect of Commiphora Myrrh Solution as a Root Canal Irrigant on Post Operative Pain and Bacterial Load Reduction in Necrotic Tooth

NCT06310044 | Not Yet Recruiting

• 1 other identifier: Commiphora Myrrh
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

Clinically compare the post-operative pain , incidences post-operative swelling , post-operative number of analgesic tablets taken by patient and amount of bacterial load reduction after using 50% Commiphora Myrrh Chemomechanical preparation , versus 2.5% NaOCl,in asymptomatic necrotic mandibular premolar treated in single visit.

Conditions

Necrotic Pulp

Keywords

Asymptomatic Necrotic Mandibular Premolar

Outcome Measures

Primary Outcomes (1)

• Post-operative pain

  Categorical None 0 Mild 1-3 Moderate 4-6 Sever 7-10

  Post-operative pain measured at 6,12,24,48 hours after single visit Treatment

Secondary Outcomes (1)

• incidence of Post-operative swelling

  Up to 48 hours post-

Other Outcomes (2)

• Amount of intracanal Bacterial CFUs/ml

  Pre-intervention, pre-instrumentation after access cavity. Post-instrumentation up to 10min

• Number of analgesic Counting Tablets taken by the patient after endodontic treatment

  Up to 48hours post-operative

Study Arms (2)

Commiphora Myrrh

EXPERIMENTAL

50% Commiphora Myrrh

Other: Root canal irrigant Commiphora Myrrh 50%

Sodium hypochlorite

ACTIVE COMPARATOR

2.5% NaOCl

Other: Root canal irrigant Commiphora Myrrh 50%

Interventions

Root canal irrigant Commiphora Myrrh 50% OTHER

Root canal irrigant

Commiphora Myrrh; Sodium hypochlorite

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Systemically healthy patient (ASA I, II).
• Age between 20 and 40 years.
• Male or female.
• Patient who is able to sign and comprehend the pain scale (committed patient).
• Mandibular single rooted premolars having the following criteria:
• With single root canal.
• Diagnosed clinically with pulp necrosis.
• Absence of spontaneous pulpal pain.
• Positive pain on percussion denoting apical periodontitis.
• Slight widening of periodontal space or peri-apical radiolucency smaller than 3 mm (0-2mm)

You may not qualify if:

• Medically compromised patients (ASA III or IV).
• Teeth with:
• Patients who could not interpret the NRS.
• Immature roots.
• Vital pulp tissues.
• Association with swelling.
• Acute peri-apical abscess or acute exacerbation of a chronic abscess.
• Mobility Grade II or III.
• Previously accessed or endodontically treated.
• Deep periodontal pockets more than 4 mm.
• Vertical root fractures, coronal perforation, calcification, and external or internal root resorptions.
• Patients with diabetes, immune-compromising, and immunosuppression disease and pregnant women will be also excluded.
• History of intolerance to NSAIDs.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Dental Pulp Necrosis

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Rahaf A Manzalawi, BDS

CONTACT

01150019478; rahaf.manzlawi@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 13, 2024
• Study Start: May 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share