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Zincoxide-propolis vs Zincoxide-eugenol Pulpectomy

Primary Purpose

Pulp Necroses

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Zinc oxide Propolis
Zinc Oxide-Eugenol Cement
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulp Necroses

Eligibility Criteria

4 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Children 4-6 years
  • Non-vital primary molars
  • Teeth with radiographic evidence of minimum bone loss.

Exclusion Criteria:

  • Primary molars with less than two-thirds of the remaining root length
  • Molars demonstrating extensive external or internal resorption,
  • Teeth exhibiting greater than Grade I mobility
  • Non-restorable with stainless steel
  • Children whose parents or caregivers did not give consent for the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    zinc-oxide propolis

    zinc-oxide eugenol

    Arm Description

    Propolis is a natural resinous mixture produced by honeybees from substances collected from parts of plants, buds, and exudates. The essential principle compounds responsible for biological activities are polyphenols, aromatic acids, and diterpenic acids. Numerous biological properties of propolis have been reported including cytotoxic, antiherpes, free radical scavenging, antimicrobial, and anti-HIV activities The antibacterial effect of propolis is bactericidal by inhibiting their mobility. Propolis kills the fungi and also inhibits the growth of the viruses.

    Zinc oxide-eugenol cement (ZOE) has been used as a root canal filling material for primary teeth and has long been the material of choice of pediatric dentists worldwide, although it fails to meet the ideal requirements of root canal filling material for primary teeth due to limited antimicrobial action, and a slower rate of resorption than the roots of the primary teeth. Studies report that the success rate of ZOE ranges from 65% to 86% so it's materials of choice if primary teeth are not nearing exfoliation.

    Outcomes

    Primary Outcome Measures

    Absence of Pain
    •Measuring Method : Verbal Question to Patient /Parents •Measuring Unite: Binary

    Secondary Outcome Measures

    Full Information

    First Posted
    November 30, 2021
    Last Updated
    January 28, 2022
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05230797
    Brief Title
    Zincoxide-propolis vs Zincoxide-eugenol Pulpectomy
    Official Title
    Clinical and Radiographic Evaluation of Zinc Oxide-Propolis Versus Zinc Oxide- Eugenol as Obturating Material in Primary Teeth Pulpectomy: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 2022 (Anticipated)
    Primary Completion Date
    August 2022 (Anticipated)
    Study Completion Date
    September 2022 (Anticipated)

    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
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The clinical trial aims to evaluate the clinical and radiographic success of Zinc oxide- propolis versus Zinc oxide -Eugenol as obturating material in pulpectomy of non-vital primary teeth.
    Detailed Description
    Pulpectomy is considered the most convenient way to treat the non-vital primary teeth as it preserves the affected tooth to maintain the length and integrity of the dental arch until exfoliation4. Zinc oxide-eugenol cement (ZOE) has been used as a root canal filling material for primary teeth and has long been the material of choice of pediatric dentists worldwide, although it fails to meet the ideal requirements of root canal filling material for primary teeth due to limited antimicrobial action, and a slower rate of resorption than the roots of the primary teeth. Concerns about these drawbacks of ZOE directed to search for alternative obturating materials for primary teeth. Propolis, a natural resinous substance, is collected by honey bees with potent antimicrobial and anti-inflammatory properties. The main chemical constituents present in propolis are flavonoids, phenolics, and other aromatic compounds. Considering these beneficial effects of propolis, a zinc oxide-propolis mixture is suggested to increase the survival rate and improve the treatment prognosis of non-vital primary teeth.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulp Necroses

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    38 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    zinc-oxide propolis
    Arm Type
    Experimental
    Arm Description
    Propolis is a natural resinous mixture produced by honeybees from substances collected from parts of plants, buds, and exudates. The essential principle compounds responsible for biological activities are polyphenols, aromatic acids, and diterpenic acids. Numerous biological properties of propolis have been reported including cytotoxic, antiherpes, free radical scavenging, antimicrobial, and anti-HIV activities The antibacterial effect of propolis is bactericidal by inhibiting their mobility. Propolis kills the fungi and also inhibits the growth of the viruses.
    Arm Title
    zinc-oxide eugenol
    Arm Type
    Active Comparator
    Arm Description
    Zinc oxide-eugenol cement (ZOE) has been used as a root canal filling material for primary teeth and has long been the material of choice of pediatric dentists worldwide, although it fails to meet the ideal requirements of root canal filling material for primary teeth due to limited antimicrobial action, and a slower rate of resorption than the roots of the primary teeth. Studies report that the success rate of ZOE ranges from 65% to 86% so it's materials of choice if primary teeth are not nearing exfoliation.
    Intervention Type
    Drug
    Intervention Name(s)
    Zinc oxide Propolis
    Other Intervention Name(s)
    Also called Bee wax
    Intervention Description
    antibacterial and anti-inflammatory
    Intervention Type
    Drug
    Intervention Name(s)
    Zinc Oxide-Eugenol Cement
    Other Intervention Name(s)
    ZOE
    Intervention Description
    Antimicrobial and antiseptic
    Primary Outcome Measure Information:
    Title
    Absence of Pain
    Description
    •Measuring Method : Verbal Question to Patient /Parents •Measuring Unite: Binary
    Time Frame
    9 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    6 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Children 4-6 years Non-vital primary molars Teeth with radiographic evidence of minimum bone loss. Exclusion Criteria: Primary molars with less than two-thirds of the remaining root length Molars demonstrating extensive external or internal resorption, Teeth exhibiting greater than Grade I mobility Non-restorable with stainless steel Children whose parents or caregivers did not give consent for the study

    12. IPD Sharing Statement

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    Zincoxide-propolis vs Zincoxide-eugenol Pulpectomy

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