Clinical trial NCT05792748: Comparison of Zinc Oxide Eugenol to Ferric Sulphate Pulpotomy in Primary Teeth
Official title: A Clinical Trial Comparing Reinforced Zinc Oxide Eugenol to Ferric Sulphate as a Pulpotomy Agent in Primary Teeth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulpotomy
Keywords: Ferric sulphate
Zinc Oxide Eugenol
Pulpotomy
Primary dentition
Lead sponsor: King Abdullah University Hospital
Sponsor class: OTHER
Collaborators: name: Jordan University of Science and Technology
First posted: 2023-03-31
Enrollment: 65
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of teeth which are asymptomatic without clinical signs of disease
timeFrame: 24 months
measure: Number of teeth with no pathological changes present
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: Jordan University of Science and Technology
Study officials:
affiliation: Jordan University of Science and Technology
name: Ola B. Al-Batayneh
role: PRINCIPAL_INVESTIGATOR
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