MedTrace Logo

A Clinical Trial Comparing FS With ZOE and Non-eugenol Based Materials in Primary Teeth Pulpotomies

NCT05557812 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2025-02-26

No results posted yet for this study

Summary

Internal resorption in the most common cause of failure in FS pulpotomies in primary molars. This has been attributed to the release of free eugenol from the zinc and eugenol mixture of the base material over the pulp tissue. Zinc oxide-eugenol (ZOE) paste is the most common base material placed over the infected pulp tissues during pulpotomies of primary molars, however the evidence suggests that the eugenol component has been associated with the failure of the vital pulp treatment in primary molars. Cavit (3M, US) is another base material that contains Zinc-oxide, zinc sulphate, and calcium salts without eugenol. The effectiveness of non-eugenol based Zinc oxide as a base material over ferric sulphate treated pulp has not been explored. The hypothesis is that the non-eugenol based ZOE could be used as an alternate to eugenol based ZOE and thereby avoid the radiological failures. Therefore, this randomized controlled clinical split-mouth trial aimed to evaluate and compare the effect of eugenol and non-eugenol based ZOE on the success of primary tooth pulpotomies where FS is used as a medicament.

Conditions

  • Pulpitis

Interventions

DRUG

non-eugenol based ZOE base material with Ferric Sulfate in primary molar pulpotomies

non-eugenol based ZOE base material placed over ferric sulphate, during vital pulp therapy (pulpotomy) in primary molars

DRUG

eugenol based zinc oxide and Ferric Sulfate

eugenol based zinc oxide base material placed over Ferric Sulfate medicament, during vital pulp therapy (pulpotomy) in primary molars

Sponsors & Collaborators

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Jayakumar Jayaraman, BDS MDS PhD · Virginia Commonwealth University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-02
Primary Completion
2025-02-01
Completion
2025-02-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05557812 on ClinicalTrials.gov