Effect of Moringa Oleifera Leaf Extract on Postoperative Pain and Bacterial Reduction in Mandibular Premolars

Effect of Moringa Oleifera Leaf Extract Versus Sodium Hypochlorite as Root Canal Irrigant on Postoperative Pain and Bacterial Reduction in Mandibular Premolars With Necrotic Pulps: A Randomized Clinical Trial

The aim of this study is to clinically compare the intensity of post-operative pain and the amount of bacterial reduction after using Moringa oleifera leaf extract solution during chemo-mechanical preparation, versus 2.5% NaOCl, in asymptomatic necrotic mandibular premolars treated in a single visit

Study Overview

• Status: Not yet recruiting
• Conditions: Necrotic Pulp
• Intervention / Treatment: Dietary supplement: Moringa oleifera leaf; Drug: Sodium hypochlorite

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Systematically healthy patient (ASA I,II).
2. Age between 20 and 55 years
3. Male or female.
4. Asymptomatic mandibular premolar teeth diagnosed with pulp necrosis with apical periodontitis.
5. Radiographic examination using Digora intraoral periapical sensor plate and software (Digora; Soredex, Helsinki, Finland) showing mandibular premolars with (smaller than 3 mm (0-2 mm)) periapical radiolucency.

Exclusion Criteria:

1. Medically compromised patients having significant systemic disorders. (ASA III or IV).
2. History of intolerance to NSAIDS.

3. Teeth with:

   • 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 who could not interpret the NRS.
5. Patients with diabetes, immune-compromising, and immunosuppression disease and pregnant women were, also, excluded.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Moringa oleifera	Dietary supplement: Moringa oleifera leaf; Leaf extract preparation
Active Comparator: Sodium hypochlorite	Drug: Sodium hypochlorite; 2.5% sodium hypochlorite (household bleaching agent)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	postoperative pain will be marked by the patient using the Numerical rating scale (NRS) chart which is an 11 point scale consisting of numbers from 0 through 10, where: 0: reading represents "no pain" 1-3: readings represent "mild pain" 4-6: readings represent "moderate pain" 7-10: readings represent "severe pain"	up to 48 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intracanal bacterial load change	The intracanal bacterial load change will be determined using agar culture technique by counting the colony forming units per milliliter (CFUs/mL) before and after root canal preparation.	First sample is taken at Time 0 "T0" then second sample taken after chemo-mechanical preparation on 15 minutes at Time 1 "T1".

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: April 17, 2022
• First Submitted That Met QC Criteria: April 26, 2022
• First Posted (Actual): April 27, 2022

Study Record Updates

• Last Update Posted (Actual): August 9, 2022
• Last Update Submitted That Met QC Criteria: August 8, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• 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; Sodium Hypochlorite; Eusol
• Other Study ID Numbers: ENDO 3 -7 -1

Drug and device information, study documents

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