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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04983524
Other study ID # SSirry
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2015
Est. completion date May 2018

Study information

Verified date July 2021
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date May 2018
Est. primary completion date May 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 40 Years
Eligibility 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


Intervention

Dietary Supplement:
propolis
resinous product of honeybees
Drug:
Calcium Hydroxide
Gold standard control intracanal medicament

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary post-operative pain Categorical data on numerical rating scale one week. line of 10 points
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