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Tooth Discoloration Induced by Pulpotomy Materials

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04346849
Enrollment
107
Registered
2020-04-15
Start date
2017-09-02
Completion date
2025-05-02
Last updated
2024-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tooth Discoloration

Keywords

Pulpotomy, MTA, Biodentine, Bioceramic, discoloration

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.

Interventions

PROCEDUREPulpotomy

Cutting the coronal portion of the pulp and application of a calcium silicate based material followed by restoration

Sponsors

Jordan University of Science and Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

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

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.

Eligibility

Sex/Gender
ALL
Age
16 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Tooth color changeImmediate, 6 months, 1 year and yearly up to 5 yearsDarkening in tooth color shade after placement of the calcium silicate based material

Countries

Jordan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026