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

NCT05348824 | Unknown Phase 2

• 1 other identifier: ENDO 3 -7 -1
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Necrotic Pulp

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Intracanal bacterial load change

  First sample is taken at Time 0 "T0" then second sample taken after chemo-mechanical preparation on 15 minutes at Time 1 "T1".

Study Arms (2)

Moringa oleifera

EXPERIMENTAL

Dietary Supplement: Moringa oleifera leaf

Sodium hypochlorite

ACTIVE COMPARATOR

Drug: Sodium hypochlorite

Interventions

Moringa oleifera leaf DIETARY_SUPPLEMENT

Leaf extract preparation

Moringa oleifera

Sodium hypochlorite DRUG

2.5% sodium hypochlorite (household bleaching agent)

Sodium hypochlorite

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Systematically healthy patient (ASA I,II).
• Age between 20 and 55 years
• Male or female.
• Asymptomatic mandibular premolar teeth diagnosed with pulp necrosis with apical periodontitis.
• 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.

You may not qualify if:

• Medically compromised patients having significant systemic disorders. (ASA III or IV).
• History of intolerance to NSAIDS.
• 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.
• Patients who could not interpret the NRS.
• Patients with diabetes, immune-compromising, and immunosuppression disease and pregnant women were, also, excluded.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Dental Pulp Necrosis

Interventions

Sodium Hypochlorite

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hypochlorous Acid; Chlorine Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (Endodontic Resident)

Study Record Dates

• First Submitted: April 17, 2022
• First Posted: April 27, 2022
• Study Start: August 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: April 1, 2023
• Last Updated: August 9, 2022

Record last verified: 2022-08