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NCT05230797 Clinical Trial

Zincoxide-propolis vs Zincoxide-eugenol Pulpectomy

Pulp Necroses Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05230797
Other study ID # ZOP pulpectomy
Secondary ID
Status Not yet recruiting
Phase Early Phase 1
First received
Last updated
Start date April 2022
Est. completion date September 2022

Study information
Verified date January 2022
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 38
Est. completion date September 2022
Est. primary completion date August 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 6 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Zinc oxide Propolis
antibacterial and anti-inflammatory
• Zinc Oxide-Eugenol Cement
Antimicrobial and antiseptic

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Outcome
Type Measure Description Time frame Safety issue
Primary Absence of Pain •Measuring Method : Verbal Question to Patient /Parents
•Measuring Unite: Binary		 9 months
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