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

Not Applicable

Completed

• Conditions: Post-Operative Pain, Chronic; Necrotic Pulp
• Interventions: Dietary Supplement: propolis; Drug: Calcium Hydroxide

• Registration Number: NCT04983524
• Lead Sponsor: Cairo University

Brief Summary

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

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 Timeline

• Study Start: 2015-10
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Status Verified: 2021-07
• Study First Submitted: 2021-07-11
• Study First Submitted QC: 2021-07-20
• Last Update Submitted: 2021-07-20
• Study First Posted: 2021-07-30
• Last Update Posted: 2021-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propolis	propolis	intervention intracanal medicament
Calcium Hudroxide	Calcium Hydroxide	Gold standard intracanal medicament

Primary Outcome Measures

Name	Time	Method
post-operative pain	one week. line of 10 points	Categorical data on numerical rating scale