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

NCT05792748 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2023-03-31

No results posted yet for this study

Summary

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.

Conditions

  • Pulpotomy

Interventions

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

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

PROCEDURE

Stainless steel crown

Stainless steel crown placed as a final restoration

Sponsors & Collaborators

  • Jordan University of Science and Technology

    collaborator OTHER

  • King Abdullah University Hospital

    lead OTHER

Principal Investigators

  • Ola B. Al-Batayneh · Jordan University of Science and Technology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-02
Primary Completion
2014-01-02
Completion
2014-04-01

Countries

  • Jordan

Study Locations

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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 NCT05792748 on ClinicalTrials.gov