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Enrolling by Invitation

NCT Number: NCT06973057

Direct Pulp Capping Versus Pulpotomy for Primary Molars

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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Key information

Age range

4 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jordan Univeristy of Science and Technology

Irbid, 22110, Jordan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pulpotomy

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 (DPC)

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.

Primary outcomes

  1. Clinical success

    Time frame: 24 months

    No post-treatment signs or symptoms such as sensitivity, pain, mobility or swelling should be evident.

  2. Radiographic success

    Time frame: 24 months

    No radiographic evidence of pathologic external or internal root resorption, periapical or furcation radiolucency.

Sponsors and collaborators

Lead sponsor

King Abdullah University Hospital

Other

Collaborators

  • Jordan University of Science and Technology

Registry information

Official study title

Direct Pulp Capping Versus Pulpotomy Using Neo MTA for Carious Primary Molars: a Split Mouth Randomized Clinical Trial

Acronym: MTA

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 15, 2025
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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