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

Evaluation of Commiphora Myrrh Versus Sodium Hypochlorite as Root Canal Irrigant on Post- Operative Pain and Bacterial Load Reduction in Symptomatic Mandibular Premolar Teeth With Necrotic Pulp. (A Randomized Clinical Trial)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Necrotic Pulp
• Intervention / Treatment: Other: Root canal irrigant Commiphora Myrrh 50%

Detailed Description

The patients will be randomly divided into 2 groups. Intervention group (50% Commiphora Myrrh solution root canal irrigant) and control group (2.5% sodium hypochlorite root canal irrigant)

Post-operative pain will be measured at 6,12,24,48 hours post-operatively The pain will be recorded using numerical rating scale

Post-operative swelling will be measured at 6,12,24,48 hours post-operatively The swelling will be receded using visual swelling rating scale

Number of analgesic tablets taken by the patient post-operatively. Up to 48 hours

Amount of bacteria load reduction The intracanal bacterial load reduction will be determined using agar culture technique by counting the colony forming units per milliliter (CFI /ml) before and after root canal preparation.

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rahaf A Manzalawi, BDS; Phone Number: +20 01150019478; Email: rahaf.manzlawi@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Systemically healthy patient (ASA I, II).
2. Age between 20 and 40 years.
3. Male or female.
4. Patient who is able to sign and comprehend the pain scale (committed patient).

5. 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)

Exclusion Criteria:

1. Medically compromised patients (ASA III or IV).
2. Teeth with:

3. 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.
4. Patients with diabetes, immune-compromising, and immunosuppression disease and pregnant women will be also excluded.
5. History of intolerance to NSAIDs.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Commiphora Myrrh; 50% Commiphora Myrrh	Other: Root canal irrigant Commiphora Myrrh 50%; Root canal irrigant
Active Comparator: Sodium hypochlorite; 2.5% NaOCl	Other: Root canal irrigant Commiphora Myrrh 50%; Root canal irrigant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of Post-operative swelling	Categorical Of visual swelling scale of post- operative	Up to 48 hours post-

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of intracanal Bacterial CFUs/ml	Intra canal bacterial load reduction will be determined using agar culture technique by counting the colony forming units per milliliter (CFUs/ml) before and after root canal preparation	Pre-intervention, pre-instrumentation after access cavity. Post-instrumentation up to 10min
Number of analgesic Counting Tablets taken by the patient after endodontic treatment	Counting the tablet after the treatment	Up to 48hours post-operative

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: March 7, 2024
• First Submitted That Met QC Criteria: March 7, 2024
• First Posted (Actual): March 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Asymptomatic Necrotic Mandibular Premolar
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pain, Postoperative; Necrosis; Dental Pulp Necrosis; Anti-Infective Agents; Disinfectants; Dental Disinfectants; Root Canal Irrigants
• Other Study ID Numbers: Commiphora Myrrh

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No