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

NCT ID: NCT05348824

Last Updated: 2022-08-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-31
• Study Completion Date: 2023-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Moringa oleifera

Group Type: EXPERIMENTAL

Moringa oleifera leaf

Intervention Type: DIETARY_SUPPLEMENT

Leaf extract preparation

Sodium hypochlorite

Group Type: ACTIVE_COMPARATOR

Sodium hypochlorite

Intervention Type: DRUG

2.5% sodium hypochlorite (household bleaching agent)

Interventions

Moringa oleifera leaf

Leaf extract preparation

Intervention Type: DIETARY_SUPPLEMENT

Sodium hypochlorite

2.5% sodium hypochlorite (household bleaching agent)

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mina Alfred Loka

Principal Investigator (Endodontic Resident)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

ENDO 3 -7 -1

Identifier Type: -

Identifier Source: org_study_id