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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05792748
Enrollment
65
Registered
2023-03-31
Start date
2013-01-02
Completion date
2014-04-01
Last updated
2023-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulpotomy

Keywords

Ferric sulphate, Zinc Oxide Eugenol, Pulpotomy, Primary dentition

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.

Interventions

PROCEDUREPulp hemostasis with a dry cotton pellet

Application of a dry cotton pellet, then the chamber was filled with ZOE directly over the pulp

PROCEDUREPulp 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

Stainless steel crown placed as a final restoration

Sponsors

Jordan University of Science and Technology
CollaboratorOTHER
King Abdullah University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
4 Years to 10 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of teeth which are asymptomatic without clinical signs of disease24 monthsincluding percussion sensitivity, spontaneous pain, mobility, or abscess (Clinical)
Number of teeth with no pathological changes present24 monthsincluding radiolucency, root or bone resorption (Radiographic)

Countries

Jordan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026