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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

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:

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.

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

NCT ID

NCT05146713

First Posted

October 17, 2021

Last Updated

December 2, 2021

Sponsor

Cairo University

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

Studies a U.S. FDA-regulated Device Product

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

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

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

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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