Zincoxide-propolis vs Zincoxide-eugenol Pulpectomy

NCT05230797 | Unknown Early Phase 1 DMC

• 1 other identifier: ZOP pulpectomy
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pulp Necroses

Outcome Measures

Primary Outcomes (1)

• Absence of Pain

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

  9 months

Study Arms (2)

zinc-oxide propolis

EXPERIMENTAL

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

zinc-oxide eugenol

ACTIVE COMPARATOR

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

Interventions

Zinc oxide Propolis DRUG

antibacterial and anti-inflammatory

Also known as: Also called Bee wax

zinc-oxide propolis

Zinc Oxide-Eugenol Cement DRUG

Antimicrobial and antiseptic

Also known as: ZOE

zinc-oxide eugenol

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Dental Pulp Necrosis

Interventions

Zinc Oxide-Eugenol Cement

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Cements; Dental Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: February 9, 2022
• Study Start: April 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: September 1, 2022
• Last Updated: February 9, 2022

Record last verified: 2022-01