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

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT04983524

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post-Operative Pain, Chronic Necrotic Pulp	Dietary Supplement: propolis Drug: Calcium Hydroxide	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Diagnostic

Official 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)

Actual Study Start Date :

Oct 1, 2015

Actual Primary Completion Date :

May 1, 2018

Actual Study Completion Date :

May 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Propolis intervention intracanal medicament	Dietary Supplement: propolis resinous product of honeybees
Active Comparator: Calcium Hudroxide Gold standard intracanal medicament	Drug: Calcium Hydroxide Gold standard control intracanal medicament

Arm

Intervention/Treatment

Experimental: Propolis

intervention intracanal medicament

Dietary Supplement: propolis

resinous product of honeybees

Active Comparator: Calcium Hudroxide

Gold standard intracanal medicament

Drug: Calcium Hydroxide

Gold standard control intracanal medicament

Outcome Measures

Primary Outcome Measures

post-operative pain [one week. line of 10 points]
Categorical data on numerical rating scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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