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

December 2, 2021 updated by: Radwa Mohamed Saleh Elaguizy, Cairo University

Effect Of Propolis Nanoparticles 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 20mg/ml propolis nanoparticles 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

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

44

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Propolis nanoparticles extract solution
Dietary supplement: Propolis nanoparticles extract solution
20 mg/ml propolis nanoparticles in the form of solution prepared from honeybee from various plants.
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
Time Frame: up to 48 hours postoperatively
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
Time Frame: Throughout the chemo-mechanical preparation of the canal.
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.
Throughout the chemo-mechanical preparation of the canal.
Number of analgesic tablets taken by the patient after endodontic treatment
Time Frame: Up to 48 hours postoperative.
Up to 48 hours postoperative.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2022

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

October 17, 2021

First Submitted That Met QC Criteria

December 2, 2021

First Posted (Actual)

December 7, 2021

Study Record Updates

Last Update Posted (Actual)

December 7, 2021

Last Update Submitted That Met QC Criteria

December 2, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENDO 3-7-1 CairoU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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