Direct Pulp Capping in Primary Molars

Study Overview
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Brief Summary
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The purpose of this study is to Assess the effect of MTA and hard setting Calcium Hydroxide (Dycal) on the clinical and radiographic outcome of direct pulp capping in primary molars and evaluate overall success rate of direct pulp capping in primary molars.

Detailed Description
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After informed consent, baseline clinical and radiographic assessment will be obtained and recorded in patient examination sheet. Participants who met the inclusion criteria were randomly allocated to two groups (n = 26/group, N = 52 in total) according to the capping martials using the envelope randomization method. 2 study groups according to capping material that will be used (Dycal or MTA) and each group will be divided to 2 subgroups according to site of exposure axial or pulpal. All patients were recalled and their treated molars were evaluated clinically and radiographically at 3months, 6months, 9months ,12months follow up periods.

Official Title
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Clinical Evaluation of Direct Pulp Capping in Primary Molars

Conditions
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Direct Pulp Capping

Intervention / Treatment
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* Other: Mineral trioxide aggregate (MTA)
* Other: Hard setting Calcium Hydroxide (Dycal)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cooperative child and compliant parent. Complete physical and mental health. Children who are known to be healthy and free from systemic diseases. Primary molars with deep carious lesions leading to pathological exposure but with no signs or symptoms of irreversible pulpitis or necrosis such as spontaneous pain, tenderness to percussion, abscess, fistula, periodontal tissue swelling, or abnormal tooth mobility. Exclusion Criteria: A deep carious lesion in close proximity to the pulp with an intact lamina dura. Absence of widening of periodontal membrane space or radiolucency at the furcation and periapical region. Absence of pulpal calcifications, obliteration of the pulp and root canal, or internal/external root resorption.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 7 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
Interventional Model Description: After informed consent, baseline clinical and radiographic assessment will be obtained and recorded in patient examination sheet. Participants who met the inclusion criteria were randomly allocated to two groups (n = 26/group, N = 52 in total) according to the capping martials using the envelope randomization method. All patients were recalled and their treated molars were evaluated clinically and radiographically at 3months, 6months, 9months ,12months follow up periods. 2 study groups according to capping material that will be used (Dycal or MTA) and each group will be divided to 2 subgroups according to site of exposure axial or pulpal
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mineral trioxide aggregate (MTA)<br>where the pulp tissue is exposed during final caries removal, hemostasis will be achieved by cavity irrigation with sterile saline solution for up to 4 minutes till control of bleeding Teeth with pulp exposure less than 1mm in diameter surrounded by sound dentin will be candidates for direct pulp capping Following the removal of the saline, the exposed pulp will be irrigated with 17% EDTA solution (Prevest Direct, India) for 1 minute According to site of exposure, the groups will be further subdivided into Group A (n=13) with exposure in pulpal floor and Group B (n=13) with exposure in axial wall of the cavity. Exposed pulp will be covered with fast set MTA paste after cavity dryness with sterile cotton pellet then the tooth will be restored with Self-cured glass ionomer restorative material (SDI Riva self-cure, Australia) and tooth will be covered by stainless steel crown | Other: Mineral trioxide aggregate (MTA)<br>* Materials for Vital Pulp Capping<br>* Other names: CERKAMED, Poland;|
| Active Comparator: Hard setting Calcium Hydroxide (Dycal)<br>where the pulp tissue is exposed during final caries removal, hemostasis will be achieved by cavity irrigation with sterile saline solution for up to 4 minutes till control of bleeding Teeth with pulp exposure less than 1mm in diameter surrounded by sound dentin will be candidates for direct pulp capping Following the removal of the saline, the exposed pulp will be irrigated with 17% EDTA solution (Prevest Direct, India) for 1 minute According to site of exposure, the groups will be further subdivided into Group A (n=13) with exposure in pulpal floor and Group B (n=13) with exposure in axial wall of the cavity. Exposed pulp will be covered with Dycal paste after cavity dryness with sterile cotton pellet then the tooth will be restored with Self-cured glass ionomer restorative material (SDI Riva self-cure, Australia) and tooth will be covered by stainless steel crown | Other: Hard setting Calcium Hydroxide (Dycal)<br>* Materials for Vital Pulp Capping<br>* Other names: Promedica Urbical, Germany;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical success of direct pulp capping treatment after 3 months follow up | Presence of any of these clinical findings will be considered failure: pain on mastication or spontaneous pain, as reported by the patient, without clinical evidence of plaque retention around the crown margin denoting bad oral hygiene. pain on percussion on clinical examination . non-physiologic mobility. fistula or sinus tract. | 3 months | 
| clinical success of direct pulp capping treatment after 6 months follow up | Presence of any of these clinical findings will be considered failure: pain on mastication or spontaneous pain, as reported by the patient, without clinical evidence of plaque retention around the crown margin denoting bad oral hygiene. pain on percussion on clinical examination . non-physiologic mobility. fistula or sinus tract. | 6 months follow up | 
| clinical success of direct pulp capping treatment after 9 months follow up | Presence of any of these clinical findings will be considered failure: pain on mastication or spontaneous pain, as reported by the patient, without clinical evidence of plaque retention around the crown margin denoting bad oral hygiene. pain on percussion on clinical examination . non-physiologic mobility. fistula or sinus tract. | 9 months follow up | 
| clinical success of direct pulp capping treatment after 12 months follow up | Presence of any of these clinical findings will be considered failure: pain on mastication or spontaneous pain, as reported by the patient, without clinical evidence of plaque retention around the crown margin denoting bad oral hygiene. pain on percussion on clinical examination . non-physiologic mobility. fistula or sinus tract. | 12 months follow up | 
| radiographic success of direct pulp capping treatment after 3 months follow up | the absence of the following radiographic findings indicate the success of capping material in pulp therapy: pathological internal or external root resorption. PDL widening. inter-radicular radiolucency formation postoperatively. periapical radiolucency formation postoperatively. | 3 months follow up | 
| radiographic success of direct pulp capping treatment after 6 months follow up | the absence of the following radiographic findings indicate the success of capping material in pulp therapy: pathological internal or external root resorption. PDL widening. inter-radicular radiolucency formation postoperatively. periapical radiolucency formation postoperatively. | 6 months follow up | 
| radiographic success of direct pulp capping treatment after 9 months follow up | the absence of the following radiographic findings indicate the success of capping material in pulp therapy: pathological internal or external root resorption. PDL widening. inter-radicular radiolucency formation postoperatively. periapical radiolucency formation postoperatively. | 9 months follow up | 
| radiographic success of direct pulp capping treatment after 12 months follow up | the absence of the following radiographic findings indicate the success of capping material in pulp therapy: pathological internal or external root resorption. PDL widening. inter-radicular radiolucency formation postoperatively. periapical radiolucency formation postoperatively. | 12 months follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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primary dentition, MTA, Dycal, bioactive material, deciduous dentition, Direct pulp capping