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

Study Overview
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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.

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

Conditions
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Necrotic Pulp, Post-Operative Pain, Chronic

Intervention / Treatment
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* Dietary Supplement: propolis
* Drug: Calcium Hydroxide


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propolis<br>intervention intracanal medicament | Dietary Supplement: propolis<br>* resinous product of honeybees<br>|
| Active Comparator: Calcium Hudroxide<br>Gold standard intracanal medicament | Drug: Calcium Hydroxide<br>* Gold standard control intracanal medicament<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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calcium hydroxide, propolis, post-operative pain, necrotic pulp