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

Necrotic Pulp Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05348824
• Other study ID #: ENDO 3 -7 -1
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: August 2022
• Est. completion date: April 2023

Study information

• Verified date: August 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: April 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• Moringa oleifera leaf
Leaf extract preparation

Drug:
• Sodium hypochlorite
2.5% sodium hypochlorite (household bleaching agent)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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".