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Effect of Propolis Nanoparticles on Postoperative Pain and Bacterial Reduction in Mandibular Premolars

NCT ID: NCT05146713

Last Updated: 2021-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-31

Study Completion Date

2022-12-31

Brief Summary

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The aim of this study is to clinically compare the intensity of post-operative pain and the amount of bacterial reduction after using 20mg/ml propolis nanoparticles extract solution during chemo-mechanical preparation, versus 2.5% NaOCl, in asymptomatic necrotic mandibular premolars treated in a single visit.

Detailed Description

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Conditions

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Necrotic Pulp

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Propolis nanoparticles extract solution

Group Type EXPERIMENTAL

Propolis nanoparticles extract solution

Intervention Type DIETARY_SUPPLEMENT

20 mg/ml propolis nanoparticles in the form of solution prepared from honeybee from various plants.

sodium hypochlorite

Group Type ACTIVE_COMPARATOR

sodium hypochlorite

Intervention Type DRUG

2.5% sodium hypochlorite (household bleaching agent)

Interventions

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Propolis nanoparticles extract solution

20 mg/ml propolis nanoparticles in the form of solution prepared from honeybee from various plants.

Intervention Type DIETARY_SUPPLEMENT

sodium hypochlorite

2.5% sodium hypochlorite (household bleaching agent)

Intervention Type DRUG

Eligibility Criteria

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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 or without 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

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Radwa Mohamed Saleh Elaguizy

Principal Investigator (Endodontic Resident)

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Radwa Mohamed Saleh Elaguizy

Role: CONTACT

Phone: +201091782522

Email: [email protected]

Other Identifiers

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ENDO 3-7-1 CairoU

Identifier Type: -

Identifier Source: org_study_id