Tooth Discoloration Induced by Pulpotomy Materials

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Tooth Discoloration

Intervention / Treatment
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* Procedure: Pulpotomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MTA pulpotomy<br>Teeth receiving pulpotomy using MTA | Procedure: Pulpotomy<br>* Cutting the coronal portion of the pulp and application of a calcium silicate based material followed by restoration<br>|
| Experimental: Biodentine pulpotomy<br>Teeth receiving pulpotomy using Biodentine | Procedure: Pulpotomy<br>* Cutting the coronal portion of the pulp and application of a calcium silicate based material followed by restoration<br>|
| Experimental: Bioceramic pulpotomy<br>Teeth receiving pulpotomy using Bioceramic | Procedure: Pulpotomy<br>* Cutting the coronal portion of the pulp and application of a calcium silicate based material followed by restoration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulpotomy, MTA, Biodentine, Bioceramic, discoloration