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

Not Applicable

Completed

• Conditions: Pulpotomy
• Interventions: Procedure: Pulp hemostasis with a dry cotton pellet; Procedure: Pulp hemostasis with a wet cotton pellet impregnated with FS; Procedure: Stainless steel crown

• Registration Number: NCT05792748
• Lead Sponsor: King Abdullah University Hospital

Brief 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.

Study Timeline

• Study Start: 2013-01-02
• Primary Completion: 2014-01-02
• Study Completion: 2014-04-01
• Study First Submitted: 2023-02-24
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-30
• Last Update Submitted: 2023-03-30
• Study First Posted: 2023-03-31
• Last Update Posted: 2023-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ZOE group	Stainless steel crown	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.
ZOE group	Pulp hemostasis with a dry cotton pellet	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.
FS group	Pulp hemostasis with a wet cotton pellet impregnated with FS	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.
FS group	Stainless steel crown	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Jordan University of Science and Technology; 🇯🇴 Irbid, Jordan