NCT06973057

Direct Pulp Capping Versus Pulpotomy for Primary Molars

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: King Abdullah University Hospital · Academic / Other
• Sex: All
• Age: 4 Years – 10 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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

• Vital Pulp Therapies

Interventions

Type	Name	Description
PROCEDURE	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.
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.

Timeline

• Start date: 2023-10-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-05-15
• Last updated: 2025-05-15

Locations

1 site across 1 country: Jordan