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

NCT05146713 | Unknown Phase 2

• 1 other identifier: ENDO 3-7-1 CairoU
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Necrotic Pulp

Outcome Measures

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"

  up to 48 hours postoperatively

Secondary Outcomes (2)

• Intracanal bacterial load change

  Throughout the chemo-mechanical preparation of the canal.

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

  Up to 48 hours postoperative.

Study Arms (2)

Propolis nanoparticles extract solution

EXPERIMENTAL

Dietary Supplement: Propolis nanoparticles extract solution

sodium hypochlorite

ACTIVE COMPARATOR

Drug: sodium hypochlorite

Interventions

Propolis nanoparticles extract solution DIETARY_SUPPLEMENT

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

Propolis nanoparticles extract solution

sodium hypochlorite DRUG

2.5% sodium hypochlorite (household bleaching agent)

sodium hypochlorite

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Dental Pulp Necrosis

Interventions

Sodium Hypochlorite

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hypochlorous Acid; Chlorine Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Sodium Compounds

Central Study Contacts

Radwa Mohamed Saleh Elaguizy

CONTACT

+201091782522; radwa.mohamed@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (Endodontic Resident)

Study Record Dates

• First Submitted: October 17, 2021
• First Posted: December 7, 2021
• Study Start: January 1, 2022
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 7, 2021

Record last verified: 2021-12