Direct Pulp Capping in Primary Molars

Mansoura University

Status and phase: Completed; Phase 3

Conditions: Direct Pulp Capping

Treatments: Other: Hard setting Calcium Hydroxide (Dycal); Other: Mineral trioxide aggregate (MTA)

Study type: Interventional

Funder types: Other

Identifiers

NCT05530954

DPC in primary molars

Details and patient eligibility

About

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.

Full 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.

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.

Enrollment: 52 patients

Sex: All

Ages: 4 to 7 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 2 patient groups

Mineral trioxide aggregate (MTA)

Active Comparator group

Description:

* 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

Treatment:

Other: Mineral trioxide aggregate (MTA)

Hard setting Calcium Hydroxide (Dycal)

Active Comparator group

Description:

* 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

Treatment:

Other: Hard setting Calcium Hydroxide (Dycal)