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Completed

NCT Number: NCT04983524

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propolis

Dietary Supplement

resinous product of honeybees

Calcium hydroxide

Drug

Gold standard control intracanal medicament

Primary outcomes

  1. post-operative pain

    Time frame: one week. line of 10 points

    Categorical data on numerical rating scale

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jul 30, 2021
Registry last updated
Jul 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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