Zincoxide-propolis vs Zincoxide-eugenol Pulpectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-30

Study Completion Date

2022-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pulp Necroses

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Zinc oxide Propolis

Intervention Type DRUG

antibacterial and anti-inflammatory

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.

Group Type ACTIVE_COMPARATOR

Zinc Oxide-Eugenol Cement

Intervention Type DRUG

Antimicrobial and antiseptic

Interventions

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Zinc oxide Propolis

antibacterial and anti-inflammatory

Intervention Type DRUG

Zinc Oxide-Eugenol Cement

Antimicrobial and antiseptic

Intervention Type DRUG

Other Intervention Names

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Also called Bee wax ZOE

Eligibility Criteria

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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

Minimum Eligible Age

4 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes