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

NCT ID: NCT06310044

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2025-01-01

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.

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.

Conditions

Necrotic Pulp

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Commiphora Myrrh

50% Commiphora Myrrh

Group Type: EXPERIMENTAL

Root canal irrigant Commiphora Myrrh 50%

Intervention Type: OTHER

Root canal irrigant

Sodium hypochlorite

2.5% NaOCl

Group Type: ACTIVE_COMPARATOR

Root canal irrigant Commiphora Myrrh 50%

Intervention Type: OTHER

Root canal irrigant

Interventions

Root canal irrigant Commiphora Myrrh 50%

Root canal irrigant

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Rahaf Abdullah khalel manzalawi

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Rahaf A Manzalawi, BDS

Role: CONTACT

rahaf.manzlawi@dentistry.cu.edu.eg

01150019478 ext. +20

Other Identifiers

Commiphora Myrrh

Identifier Type: -

Identifier Source: org_study_id