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

NCT ID: NCT04983524

Last Updated: 2021-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2018-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Post-Operative Pain, Chronic Necrotic Pulp

Keywords

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calcium hydroxide propolis post-operative pain necrotic pulp

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Propolis

intervention intracanal medicament

Group Type EXPERIMENTAL

propolis

Intervention Type DIETARY_SUPPLEMENT

resinous product of honeybees

Calcium Hudroxide

Gold standard intracanal medicament

Group Type ACTIVE_COMPARATOR

Calcium Hydroxide

Intervention Type DRUG

Gold standard control intracanal medicament

Interventions

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propolis

resinous product of honeybees

Intervention Type DIETARY_SUPPLEMENT

Calcium Hydroxide

Gold standard control intracanal medicament

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Serene Mohamed Hisham Sirry

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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SSirry

Identifier Type: -

Identifier Source: org_study_id