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
About this trial
This is an interventional treatment trial for Necrotic Pulp
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.
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
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
Learn more about this trial
Effect of Propolis Nanoparticles on Postoperative Pain and Bacterial Reduction in Mandibular Premolars
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