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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06310044
Other study ID # Commiphora Myrrh
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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-
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