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

Primary Purpose

Post-Operative Pain, Chronic, Necrotic Pulp

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
propolis
Calcium Hydroxide
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Post-Operative Pain, Chronic focused on measuring calcium hydroxide, propolis, post-operative pain, necrotic pulp

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Propolis

    Calcium Hudroxide

    Arm Description

    intervention intracanal medicament

    Gold standard intracanal medicament

    Outcomes

    Primary Outcome Measures

    post-operative pain
    Categorical data on numerical rating scale

    Secondary Outcome Measures

    Full Information

    First Posted
    July 11, 2021
    Last Updated
    July 20, 2021
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04983524
    Brief Title
    Propolis Versus Calcium Hydroxide on Post-Operative Pain in Patients With Necrotic Pulp
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2015 (Actual)
    Primary Completion Date
    May 2018 (Actual)
    Study Completion Date
    May 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post-Operative Pain, Chronic, Necrotic Pulp
    Keywords
    calcium hydroxide, propolis, post-operative pain, necrotic pulp

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    46 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Propolis
    Arm Type
    Experimental
    Arm Description
    intervention intracanal medicament
    Arm Title
    Calcium Hudroxide
    Arm Type
    Active Comparator
    Arm Description
    Gold standard intracanal medicament
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    propolis
    Intervention Description
    resinous product of honeybees
    Intervention Type
    Drug
    Intervention Name(s)
    Calcium Hydroxide
    Intervention Description
    Gold standard control intracanal medicament
    Primary Outcome Measure Information:
    Title
    post-operative pain
    Description
    Categorical data on numerical rating scale
    Time Frame
    one week. line of 10 points

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    the study protocol can be shared.
    IPD Sharing Time Frame
    Will be available by November 2021
    IPD Sharing Access Criteria
    will be uploaded on google drive

    Learn more about this trial

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

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