Tooth Discoloration Induced by Pulpotomy Materials

Jordan University of Science and Technology

Status: Active, not recruiting

Conditions: Tooth Discoloration

Treatments: Procedure: Pulpotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04346849

5/2018

Details and patient eligibility

About

Vital pulp therapy including pulpotomy is commonly used for managing teeth with carious pulp exposure instead of performing root canal therapy. The gold standard materials used in this procedure are the calcium silicate based materials, however recent case reports have shown tooth discoloration caused by these materials especially MTA which is of concern to the patients. The aim of this study is to compare tooth color changes and discoloration induced by 3 calcium silicate based materials used in pulpotomy over 6 months, 12 months and yearly up to 5 years.

Full description

Pulpotomy procedure involves removal of the coronal portion of the dental pulp followed by placement of a compatible material and subsequent coronal restoration of the tooth. Mineral trioxide aggregate is the gold standard material used in pulpotomy; however it has been implicated in tooth discoloration due to it radioopacifier. newer calcium silicate based materials including Biodentine and bioceramic have different opacifier and claimed not to cause tooth discoloration in laboratory studies.

In this clinical study tooth color measurement of teeth treated by pulpotomy using these 3 materials will be taken using vita easy shade device immediately after placement of the materials, 6 months and 12 months after the treatment then yearly up to 5 years. The discoloration potential of these 3 materials will be compared. Factors that may influence tooth discoloration will be also measured and analyzed including buccal wall thickness and time of bleeding control after pulpotomy.

Enrollment: 107 patients

Sex: All

Ages: 16 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Vital tooth with carious pulp exposure to be treated by full pulpotomy
• Fully erupted upper or lower molar tooth with fully formed apex
• Tooth should have intact buccal wall (no caries or restoration)
• Tooth should be restorable by direct composite restoration

Exclusion criteria

• Partially erupted tooth
• Tooth has caries on the buccal surface
• Tooth has restoration on buccal surface
• Tooth has preoperative coronal staining compared to adjacent teeth

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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107 participants in 3 patient groups

MTA pulpotomy

Experimental group

Description:

Teeth receiving pulpotomy using MTA

Treatment:

Procedure: Pulpotomy

Biodentine pulpotomy

Experimental group

Description:

Teeth receiving pulpotomy using Biodentine

Treatment:

Procedure: Pulpotomy

Bioceramic pulpotomy

Experimental group

Description:

Teeth receiving pulpotomy using Bioceramic

Treatment:

Procedure: Pulpotomy