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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MTA pulpotomy | Experimental | Teeth receiving pulpotomy using MTA |
|
| Biodentine pulpotomy | Experimental | Teeth receiving pulpotomy using Biodentine |
|
| Bioceramic pulpotomy | Experimental | Teeth receiving pulpotomy using Bioceramic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulpotomy | Procedure | Cutting the coronal portion of the pulp and application of a calcium silicate based material followed by restoration |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nessrin Taha, DCD | Jordan University of Science and Technology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dental teaching centre Faculty Of Dentistry | Irbid | 21110 | Jordan | |||
| Jordan University of science and technology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36445467 | Derived | Taha NA, Hamdan AM, Al-Hiyasat AS. Coronal discoloration induced by calcium silicate-based cements used in full pulpotomy in mature permanent molars: a randomized clinical trial. Clin Oral Investig. 2023 Apr;27(4):1723-1730. doi: 10.1007/s00784-022-04799-x. Epub 2022 Nov 29. |
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The data will be shared in the publication of the 1 year results of the study. If furthers details or data required the study chair can be contacted by email
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| ID | Term |
|---|---|
| D014075 | Tooth Discoloration |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D011672 | Pulpotomy |
| ID | Term |
|---|---|
| D004708 | Endodontics |
| D003813 | Dentistry |
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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.
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Participant will not be informed about the type of material. Investigator will be given the material only after the pulpotomy procedure was completed according to a random sequence number generator. Upon tooth color measurement the investigator will not be informed about the type of material
| Irbid |
| 22110 |
| Jordan |