Direct Pulp Capping Versus Pulpotomy for Primary Molars

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2026-12-31

Brief Summary

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Dental caries is one of the most prevalent chronic diseases worldwide. Interventions for treating deep carious lesions in teeth with no history of pain or teeth with reversible pulpitis are referred to as vital pulp therapy; these include indirect pulp treatment (IPC), direct pulp capping (DPC), and pulpotomy. Pulpotomy is considered invasive when treating exposed primary vital pulps due to caries. Less invasive vital pulp treatment methods such as DPC might, therefore, be preferable, as they reduce chair time, less tooth structure removal and a crown might not always be a necessary permanent restoration. The aim of this clinical study is to evaluate the clinical and radiographic outcomes of DPC when compared to pulpotomy in primary molars with carious pulp exposure.

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Detailed Description

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Aim: The aim of this study is to evaluate the clinical and radiographic outcomes of direct pulp capping (DPC) when compared to pulpotomy in primary molars with carious pulp exposure using a calcium silicate-based material: neo mineral trioxide aggregate (Neo MTA).

Methods: The study will be a split mouth randomized clinical trial including children between 4-9 years old. Patients will be allocated into two treatment groups; one group will start with DPC first followed by pulpotomy on the second visit, and vice versa for the second group. The time interval between both visits will be 1-2 weeks. The pulp medicament capping material (neo MTA) will be applied over the exposure site, and then tooth will be restored with glass ionomer cement and then a crown will be placed. Cases will be followed up to 24 months after initial treatment.

Conditions

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Vital Pulp Therapies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A split mouth randomized clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Pulpotomy

The entire coronal pulp will be amputated.

Group Type ACTIVE_COMPARATOR

Pulpotomy

Intervention Type PROCEDURE

The entire coronal pulp will be amputated to the level of canal orifices, after hemostasis, NeoMTA will be placed, then tooth will be restored with glass ionomer cement, and the tooth will be subsequently restored with a crown.

Direct pulp capping

The exposure site will be left intact, no amputation of pulp tissue.

Group Type ACTIVE_COMPARATOR

Direct pulp capping (DPC)

Intervention Type PROCEDURE

At the exposure site hemostasis will be achieved, neo MTA will be placed, then tooth will be restored with glass ionomer cement, and the tooth will be subsequently restored with a crown.

Interventions

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Pulpotomy

The entire coronal pulp will be amputated to the level of canal orifices, after hemostasis, NeoMTA will be placed, then tooth will be restored with glass ionomer cement, and the tooth will be subsequently restored with a crown.

Intervention Type PROCEDURE

Direct pulp capping (DPC)

At the exposure site hemostasis will be achieved, neo MTA will be placed, then tooth will be restored with glass ionomer cement, and the tooth will be subsequently restored with a crown.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Healthy patients.
* Age 4-10 years.
* Primary molar with deep caries present bilaterally.
* Teeth should be restorable.
* Clinically normal asymptomatic tooth or symptoms of reversible pulpitis (No history of pain or provoked pain subsides upon removal of the stimulus).
* Radiographically: caries in the inner half of the dentin approaching the pulp.

Exclusion Criteria

* History of spontaneous pain.
* Soft and hard tissue pathology.
* Mobility or exfoliating tooth.
* No pulp exposure after caries excavation.
* Inability to achieve hemostasis after 6 minutes.
* Radiographically: Root resorption exceeding 1/3 of the root, apical pathology.

Minimum Eligible Age

4 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes