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

Necrotic Pulp Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05146713
• Other study ID #: ENDO 3-7-1 CairoU
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: January 2022
• Est. completion date: December 2022

Study information

• Verified date: December 2021
• Source: Cairo University
• Contact: Radwa Mohamed Saleh Elaguizy
• Phone: +201091782522
• Email: radwa.mohamed[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. completion date: December 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Pulp Necrosis
• Necrosis
• Necrotic Pulp
• Pain, Postoperative

Intervention

Dietary Supplement:
• Propolis nanoparticles extract solution
20 mg/ml propolis nanoparticles in the form of solution prepared from honeybee from various plants.

Drug:
• sodium hypochlorite
2.5% sodium hypochlorite (household bleaching agent)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Throughout the chemo-mechanical preparation of the canal.
Secondary	Number of analgesic tablets taken by the patient after endodontic treatment		Up to 48 hours postoperative.