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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pulpotomy

Intervention / Treatment
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* Procedure: Pulp hemostasis with a dry cotton pellet
* Procedure: Pulp hemostasis with a wet cotton pellet impregnated with FS
* Procedure: Stainless steel crown


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ZOE group<br>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. | Procedure: Pulp hemostasis with a dry cotton pellet<br>* Application of a dry cotton pellet, then the chamber was filled with ZOE directly over the pulp<br>Procedure: Stainless steel crown<br>* Stainless steel crown placed as a final restoration<br>|
| Active Comparator: FS group<br>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. | Procedure: Pulp hemostasis with a wet cotton pellet impregnated with FS<br>* Application of a a wet cotton pellet impregnated with FS, then the chamber was filled with ZOE directly over the pulp<br>Procedure: Stainless steel crown<br>* Stainless steel crown placed as a final restoration<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ferric sulphate, Zinc Oxide Eugenol, Pulpotomy, Primary dentition