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Status unknownNCT05146713Updated Dec 7, 2021

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

A Phase 2/3 interventional study of Propolis nanoparticles extract solution and sodium hypochlorite in Necrotic Pulp, sponsored by Cairo University. Status unknown. Open to participants aged 20 Years to 55 Years. Per ClinicalTrials.gov, last updated 2021-12-07.

Sponsored by Cairo University · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
20 Years to 55 Years
Sex
All
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Study 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.

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Conditions studied

  • Necrotic Pulp
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In context

Dental Pulp Necrosis

149 studies on the registry are indexed under Dental Pulp Necrosis; 39 are open to participants now.

This study's planned enrollment of 44 is close to the median of 44 across 139 interventional studies indexed under Dental Pulp Necrosis.

Browse Dental Pulp Necrosis studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
44 participants (estimated)

Study arms

  • Experimental
    Propolis nanoparticles extract solution

    Dietary Supplement: Propolis nanoparticles extract solution

  • Active comparator
    sodium hypochlorite

    Drug: sodium hypochlorite

Interventions

  • Dietary supplementPropolis nanoparticles extract solution

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

  • Drugsodium hypochlorite

    2.5% sodium hypochlorite (household bleaching agent)

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What researchers measure

Primary outcomes

  1. 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"

    Time frame: up to 48 hours postoperatively

Secondary outcomes

  1. 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.

    Time frame: Throughout the chemo-mechanical preparation of the canal.

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

    Time frame: Up to 48 hours postoperative.

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 7, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05146713
Lead sponsor
Cairo University
Responsible party
Radwa Mohamed Saleh Elaguizy (Principal Investigator (Endodontic Resident), Cairo University) — Principal investigator
First posted
Dec 7, 2021
Start date
Jan 2022 (estimated)
Primary completion
Nov 2022 (estimated)
Completion
Dec 2022 (estimated)
Last update
Dec 7, 2021

Study contacts

Radwa Mohamed Saleh Elaguizy
Contact
radwa.mohamed@dentistry.cu.edu.eg
+201091782522

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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