Tooth Discoloration Induced by Pulpotomy Materials

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-02

Study Completion Date

2025-05-02

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.

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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.

Conditions

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Tooth Discoloration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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

Study Groups

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MTA pulpotomy

Teeth receiving pulpotomy using MTA

Group Type EXPERIMENTAL

Pulpotomy

Intervention Type PROCEDURE

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

Biodentine pulpotomy

Teeth receiving pulpotomy using Biodentine

Group Type EXPERIMENTAL

Pulpotomy

Intervention Type PROCEDURE

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

Bioceramic pulpotomy

Teeth receiving pulpotomy using Bioceramic

Group Type EXPERIMENTAL

Pulpotomy

Intervention Type PROCEDURE

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

Interventions

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Pulpotomy

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

Intervention Type PROCEDURE

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

Minimum Eligible Age

16 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes