Tooth Discoloration Induced by Pulpotomy Materials

Tooth Discoloration Clinical Trial

Official title:

Tooth Discoloration Induced by Different Calcium Silicate Based Materials: in Vivo Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04346849
• Other study ID #: 5/2018
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2, 2017
• Est. completion date: May 2, 2025

Study information

• Verified date: May 2024
• Source: Jordan University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 107
• Est. completion date: May 2, 2025
• Est. primary completion date: May 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Tooth Discoloration

Intervention

Procedure:
• Pulpotomy
Cutting the coronal portion of the pulp and application of a calcium silicate based material followed by restoration

Locations

Country	Name	City	State
Jordan	Dental teaching centre Faculty Of Dentistry	IRbid
Jordan	Jordan University of science and technology	Irbid

Sponsors (1)

Lead Sponsor	Collaborator
Jordan University of Science and Technology

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tooth color change	Darkening in tooth color shade after placement of the calcium silicate based material	Immediate, 6 months, 1 year and yearly up to 5 years