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

Necrotic Pulp Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06310044
• Other study ID #: Commiphora Myrrh
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: January 1, 2025

Study information

• Verified date: March 2024
• Source: Cairo University
• Contact: Rahaf A Manzalawi, BDS
• Phone: 01150019478
• Email: rahaf.manzlawi[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Pulp Necrosis
• Necrosis
• Necrotic Pulp
• Pain, Postoperative

Intervention

Other:
• Root canal irrigant Commiphora Myrrh 50%
Root canal irrigant

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Number of analgesic Counting Tablets taken by the patient after endodontic treatment	Counting the tablet after the treatment	Up to 48hours post-operative
Primary	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	incidence of Post-operative swelling	Categorical Of visual swelling scale of post- operative	Up to 48 hours post-