Tooth Discoloration Induced by Pulpotomy Materials
- Conditions
- Tooth Discoloration
- Interventions
- Procedure: Pulpotomy
- Registration Number
- NCT04346849
- Lead Sponsor
- Jordan University of Science and Technology
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 107
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MTA pulpotomy Pulpotomy Teeth receiving pulpotomy using MTA Bioceramic pulpotomy Pulpotomy Teeth receiving pulpotomy using Bioceramic Biodentine pulpotomy Pulpotomy Teeth receiving pulpotomy using Biodentine
- Primary Outcome Measures
Name Time Method Tooth color change Immediate, 6 months, 1 year and yearly up to 5 years Darkening in tooth color shade after placement of the calcium silicate based material
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Dental teaching centre Faculty Of Dentistry
🇯🇴IRbid, Jordan
Jordan University of science and technology
🇯🇴Irbid, Jordan