Comparison of Zinc Oxide Eugenol to Ferric Sulphate Pulpotomy in Primary Teeth

March 30, 2023 updated by: King Abdullah University Hospital

A Clinical Trial Comparing Reinforced Zinc Oxide Eugenol to Ferric Sulphate as a Pulpotomy Agent in Primary Teeth

In this prospective randomized, single blinded; split-mouth clinical trial the aim was to evaluate clinical and radiographic effects of placement of reinforced zinc oxide eugenol (ZOE) base directly over the amputated pulp stumps in pulpotomized primary molars, and to compare this technique to ferric sulphate (FS) in pulpotomized primary teeth. Included were 65 children using a split-mouth design, (130 teeth). All teeth were then restored with prefabricated stainless steel crowns (SSC). Patients were recalled for clinical and radiographical evaluation after 3, 6, 12 and 24 months. Two experienced and calibrated pediatric dentists who were not involved in the investigation blindly assessed the radiographs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Purpose:

The purpose of this study was to evaluate the clinical and radiographic effects of placement of reinforced zinc oxide eugenol (ZOE) base directly over the amputated pulp stumps in pulpotomized primary molars, and to compare the effects of this technique to ferric sulphate (FS) agent in pulpotomized primary teeth.

Methods:

A sample of 65 children with bilateral deep carious mandibular primary molars who attended the pediatric dental clinics, at Jordan University of Science and Technology (JUST) were selected for this prospective randomized, single blinded; split-mouth clinical trial. The teeth were randomly divided into 2 treatment groups: in the ZOE group (n=65 teeth) hemostasis was achieved by a dry cotton pellet, then the chamber was filled with zinc oxide eugenol (ZOE) directly over the pulp on one side. In the FS group (n=65 teeth) hemostasis was achieved by a wet cotton pellet, ferric sulphate (FS) was applied on the pulp, then the chamber was filled with (ZOE) on the contralateral side. All teeth were restored with prefabricated stainless steel crowns (SSC). Patients were recalled for evaluation clinically after 1month, then clinically and radiographically after 3, 6, 12 and 24 months. Two experienced and calibrated pediatric dentists who were not involved in the investigation blindly assessed the radiographs.

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
      • Irbid, Jordan, 22110
        • Jordan University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 10 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy children
  • Child has cooperative behaviour in the dental chair
  • No history of spontaneous pain
  • Deep caries in the tooth
  • Carious exposure of a vital pulp
  • A restorable tooth after completion of the pulp treatment
  • Healthy periapical tissue on pre-operative periapical radiograph

Exclusion Criteria:

  • Presence of tenderness to percussion and/or mobility
  • Pathologic radiographic signs on pre-operative periapical radiograph including external or internal root resorption, calcification in the canal, periodontal membrane widening, periapical pathology, and furcation radiolucency.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ZOE group
Pulp hemostasis achieved by a dry cotton pellet applied on the pulp, then the chamber was filled with reinforced zinc oxide eugenol (ZOE) directly over the pulp.
Procedure: Pulp hemostasis with a dry cotton pellet
Application of a dry cotton pellet, then the chamber was filled with ZOE directly over the pulp
Procedure: Stainless steel crown
Stainless steel crown placed as a final restoration
Active Comparator: FS group
Pulp hemostasis achieved by a wet cotton pellet impregnated with ferric sulphate (FS) applied on the pulp, then the chamber was filled with (ZOE) directly over the pulp.
Procedure: Stainless steel crown
Stainless steel crown placed as a final restoration
Procedure: Pulp hemostasis with a wet cotton pellet impregnated with FS
Application of a a wet cotton pellet impregnated with FS, then the chamber was filled with ZOE directly over the pulp

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of teeth which are asymptomatic without clinical signs of disease
Time Frame: 24 months
including percussion sensitivity, spontaneous pain, mobility, or abscess (Clinical)
24 months
Number of teeth with no pathological changes present
Time Frame: 24 months
including radiolucency, root or bone resorption (Radiographic)
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Abdullah University Hospital

Collaborators

Jordan University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2013

Primary Completion (Actual)

January 2, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

February 24, 2023

First Submitted That Met QC Criteria

March 30, 2023

First Posted (Actual)

March 31, 2023

Study Record Updates

Last Update Posted (Actual)

March 31, 2023

Last Update Submitted That Met QC Criteria

March 30, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19/2013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pulpotomy

Clinical Trials on Pulp hemostasis with a dry cotton pellet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe