Zincoxide-propolis vs Zincoxide-eugenol Pulpectomy

Early Phase 1

• Conditions: Pulp Necroses
• Interventions: Drug: Zinc oxide Propolis; Drug: Zinc Oxide-Eugenol Cement

• Registration Number: NCT05230797
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2021-11-30
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-28
• Last Update Submitted: 2022-01-28
• Study First Posted: 2022-02-09
• Last Update Posted: 2022-02-09
• Study Start: 2022-04
• Primary Completion: 2022-08
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 38

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
zinc-oxide propolis	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.
zinc-oxide eugenol	Zinc Oxide-Eugenol Cement	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.

Primary Outcome Measures

Name	Time	Method
Absence of Pain	9 months	•Measuring Method : Verbal Question to Patient /Parents; •Measuring Unite: Binary