Trials / Active Not Recruiting
Active Not RecruitingNCT04346849
Tooth Discoloration Induced by Pulpotomy Materials
Tooth Discoloration Induced by Different Calcium Silicate Based Materials: in Vivo Study
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 107 (actual)
- Sponsor
- Jordan University of Science and Technology · Academic / Other
- Sex
- All
- Age
- 16 Years – 70 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Pulpotomy | Cutting the coronal portion of the pulp and application of a calcium silicate based material followed by restoration |
Timeline
- Start date
- 2017-09-02
- Primary completion
- 2018-05-02
- Completion
- 2025-05-02
- First posted
- 2020-04-15
- Last updated
- 2024-05-02
Locations
2 sites across 1 country: Jordan
Source: ClinicalTrials.gov record NCT04346849. Inclusion in this directory is not an endorsement.