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

Primary Purpose

Necrotic Pulp

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Propolis nanoparticles extract solution
sodium hypochlorite
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Necrotic Pulp

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Propolis nanoparticles extract solution

    sodium hypochlorite

    Arm Description

    Outcomes

    Primary Outcome Measures

    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"

    Secondary Outcome Measures

    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.
    Number of analgesic tablets taken by the patient after endodontic treatment

    Full Information

    First Posted
    October 17, 2021
    Last Updated
    December 2, 2021
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05146713
    Brief Title
    Effect of Propolis Nanoparticles on Postoperative Pain and Bacterial Reduction in Mandibular Premolars
    Official Title
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2022 (Anticipated)
    Primary Completion Date
    November 2022 (Anticipated)
    Study Completion Date
    December 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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 20mg/ml propolis nanoparticles extract solution during chemo-mechanical preparation, versus 2.5% NaOCl, in asymptomatic necrotic mandibular premolars treated in a single visit.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Necrotic Pulp

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    44 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Propolis nanoparticles extract solution
    Arm Type
    Experimental
    Arm Title
    sodium hypochlorite
    Arm Type
    Active Comparator
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Propolis nanoparticles extract solution
    Intervention Description
    20 mg/ml propolis nanoparticles in the form of solution prepared from honeybee from various plants.
    Intervention Type
    Drug
    Intervention Name(s)
    sodium hypochlorite
    Intervention Description
    2.5% sodium hypochlorite (household bleaching agent)
    Primary Outcome Measure Information:
    Title
    Postoperative pain
    Description
    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"
    Time Frame
    up to 48 hours postoperatively
    Secondary Outcome Measure Information:
    Title
    Intracanal bacterial load change
    Description
    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.
    Time Frame
    Throughout the chemo-mechanical preparation of the canal.
    Title
    Number of analgesic tablets taken by the patient after endodontic treatment
    Time Frame
    Up to 48 hours postoperative.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Systematically healthy patient (ASA I,II). Age between 20 and 55 years Male or female. Asymptomatic mandibular premolar teeth diagnosed with pulp necrosis with or without 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. Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Radwa Mohamed Saleh Elaguizy
    Phone
    +201091782522
    Email
    radwa.mohamed@dentistry.cu.edu.eg

    12. IPD Sharing Statement

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

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