NCT05792748

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: King Abdullah University Hospital · Academic / Other
• Sex: All
• Age: 4 Years – 10 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Pulpotomy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-01-02
• Primary completion: 2014-01-02
• Completion: 2014-04-01
• First posted: 2023-03-31
• Last updated: 2023-03-31

Locations

1 site across 1 country: Jordan