Direct Pulp Capping Versus Pulpotomy Using Neo MTA for Carious Primary Molars: a Split Mouth Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Clinical success
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 4 Years to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Pulpotomy
The entire coronal pulp will be amputated.
Intervention: Pulpotomy (Procedure)
Direct pulp capping
The exposure site will be left intact, no amputation of pulp tissue.
Intervention: Direct pulp capping (DPC) (Procedure)
Outcomes
Primary Outcomes
Clinical success
Time Frame: 24 months
No post-treatment signs or symptoms such as sensitivity, pain, mobility or swelling should be evident.
Radiographic success
Time Frame: 24 months
No radiographic evidence of pathologic external or internal root resorption, periapical or furcation radiolucency.
Secondary Outcomes
No secondary outcomes reported