Propolis Versus Calcium Hydroxide on Post-Operative Pain in Patients With Necrotic Pulp

July 20, 2021 updated by: Serene Mohamed Hisham Sirry, Cairo University

Evaluation of the Effect of Propolis Versus Calcium Hydroxide, Intracanal Medicaments on Post-Operative Pain in Patients With Necrotic Pulp (A Randomized Clinical Trial)

Propolis is a resinous product of honeybees. Propolis is said to be effective against resistant microorganisms inside the root canal compared to the gold standard medication known as calcium hydroxide. The clinical trial tests the effect of propolis versus calcium hydroxide on pain in patients with necrotic teeth.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Propolis is an immunomodulatory, antioxidant, flavonoid-rich resinous product of honeybees. Propolis was reported as less cytotoxic and more effective against resistant microorganisms than calcium hydroxide as well as biocompatible to the periradicular tissues than existing intracanal medicaments. The aim of this single-blinded randomized clinical trial was to evaluate the effect of propolis versus calcium hydroxide, intracanal medicaments, on post-operative pain in patients with necrotic single canal teeth. Methods: Forty-six participants with an age range of 20-40 years old, diagnosed as having necrotic pulp in their single-rooted, single canal teeth were included in this study, with 23 participants in each group. Treatment was done in two visits and intracanal medicament was applied for one week in between. Participants were instructed to rate their pain score by a numerical rating scale after 24, 48, 72 hours and at 7 days.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • • Asymptomatic patients with age range 20 - 40 years

    • Necrotic, single canal maxillary and mandibular teeth with periapical infection presented as radiolucency or widening in the periodontal membrane space.
    • Medically - free of any systemic disease
    • Teeth with complete root formation

Exclusion Criteria:

  • • Pregnant or lactating females

    • Teeth with vital pulps, internal or external resorption or anatomic abnormalities
    • Teeth with cracks, curvatures, root caries and calcified canals
    • Double or triple-rooted teeth
    • Patients with facial swelling, acute pulpal or periapical lesion
    • Teeth that are not indicated for endodontic treatment: Bad oral hygiene, mobile or recessed
    • Previously endodontically-treated teeth

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Propolis
intervention intracanal medicament
Dietary supplement: propolis
resinous product of honeybees
Active Comparator: Calcium Hudroxide
Gold standard intracanal medicament
Drug: Calcium Hydroxide
Gold standard control intracanal medicament

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post-operative pain
Time Frame: one week. line of 10 points
Categorical data on numerical rating scale
one week. line of 10 points

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

July 11, 2021

First Submitted That Met QC Criteria

July 20, 2021

First Posted (Actual)

July 30, 2021

Study Record Updates

Last Update Posted (Actual)

July 30, 2021

Last Update Submitted That Met QC Criteria

July 20, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSirry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

the study protocol can be shared.

IPD Sharing Time Frame

Will be available by November 2021

IPD Sharing Access Criteria

will be uploaded on google drive

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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