Clinical trial NCT04346849: Tooth Discoloration Induced by Pulpotomy Materials
Official title: Tooth Discoloration Induced by Different Calcium Silicate Based Materials: in Vivo Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tooth Discoloration
Keywords: Pulpotomy, MTA, Biodentine, Bioceramic, discoloration
Lead sponsor: Jordan University of Science and Technology
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 107
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three groups will receive the same treatment procedure but randomly assigned to one of three different materials, tooth color changes will be measured at certain time points and will be compared between the 3 groups.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Tooth color change
timeFrame: Immediate, 6 months, 1 year and yearly up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: IRbid
country: Jordan
facility: Dental teaching centre Faculty Of Dentistry
city: Irbid
country: Jordan
facility: Jordan University of science and technology
Study officials:
affiliation: Jordan University of Science and Technology
name: Nessrin Taha, DCD
role: STUDY_CHAIR
References: