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

Not Applicable

Not yet recruiting

• Conditions: Necrotic Pulp
• Interventions: Other: Root canal irrigant Commiphora Myrrh 50%

• Registration Number: NCT06310044
• Lead Sponsor: Cairo University

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.

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-07
• Study First Submitted QC: 2024-03-07
• Last Update Submitted: 2024-03-07
• Study First Posted: 2024-03-13
• Last Update Posted: 2024-03-13
• Study Start: 2024-05-01
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 42

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)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sodium hypochlorite	Root canal irrigant Commiphora Myrrh 50%	2.5% NaOCl
Commiphora Myrrh	Root canal irrigant Commiphora Myrrh 50%	50% Commiphora Myrrh

Primary Outcome Measures

Name	Time	Method
Post-operative pain	Post-operative pain measured at 6,12,24,48 hours after single visit Treatment	Categorical None 0 Mild 1-3 Moderate 4-6 Sever 7-10

Secondary Outcome Measures

Name	Time	Method
incidence of Post-operative swelling	Up to 48 hours post-	Categorical Of visual swelling scale of post- operative