Zincoxide-propolis vs Zincoxide-eugenol Pulpectomy

January 28, 2022 updated by: Nora Ahmed Kadry, Cairo University

Clinical and Radiographic Evaluation of Zinc Oxide-Propolis Versus Zinc Oxide- Eugenol as Obturating Material in Primary Teeth Pulpectomy: A Randomized Clinical Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

38

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: zinc-oxide propolis
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.
Drug: Zinc oxide Propolis
antibacterial and anti-inflammatory
Other Names:
  • Also called Bee wax
Active Comparator: zinc-oxide eugenol
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.
Drug: Zinc Oxide-Eugenol Cement
Antimicrobial and antiseptic
Other Names:
  • ZOE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absence of Pain
Time Frame: 9 months

•Measuring Method : Verbal Question to Patient /Parents

•Measuring Unite: Binary
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2022

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

November 30, 2021

First Submitted That Met QC Criteria

January 28, 2022

First Posted (Actual)

February 9, 2022

Study Record Updates

Last Update Posted (Actual)

February 9, 2022

Last Update Submitted That Met QC Criteria

January 28, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZOP pulpectomy

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pulp Necroses

Clinical Trials on Zinc oxide Propolis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Georgia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe