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

King Abdullah University Hospital

Status: Completed

Conditions: Pulpotomy

Treatments: Procedure: Pulp hemostasis with a wet cotton pellet impregnated with FS; Procedure: Stainless steel crown; Procedure: Pulp hemostasis with a dry cotton pellet

Study type: Interventional

Funder types: Other

Identifiers

NCT05792748

19/2013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 4 to 10 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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65 participants in 2 patient groups

ZOE group

Active Comparator group

Description:

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.

Treatment:

Procedure: Pulp hemostasis with a dry cotton pellet

Procedure: Stainless steel crown

FS group

Active Comparator group

Description:

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.

Treatment:

Procedure: Pulp hemostasis with a wet cotton pellet impregnated with FS

Procedure: Stainless steel crown