Tooth Discoloration Induced by Pulpotomy Materials

March 9, 2023 updated by: Nessrin Taha, Jordan University of Science and Technology

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
      • IRbid, Jordan, 21110
        • Dental teaching centre Faculty Of Dentistry
      • Irbid, Jordan, 22110
        • Jordan University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MTA pulpotomy
Teeth receiving pulpotomy using MTA
Procedure: Pulpotomy
Cutting the coronal portion of the pulp and application of a calcium silicate based material followed by restoration
Experimental: Biodentine pulpotomy
Teeth receiving pulpotomy using Biodentine
Procedure: Pulpotomy
Cutting the coronal portion of the pulp and application of a calcium silicate based material followed by restoration
Experimental: Bioceramic pulpotomy
Teeth receiving pulpotomy using Bioceramic
Procedure: Pulpotomy
Cutting the coronal portion of the pulp and application of a calcium silicate based material followed by restoration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tooth color change
Time Frame: Immediate, 6 months, 1 year and yearly up to 5 years
Darkening in tooth color shade after placement of the calcium silicate based material
Immediate, 6 months, 1 year and yearly up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jordan University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2017

Primary Completion (Actual)

May 2, 2018

Study Completion (Anticipated)

May 2, 2025

Study Registration Dates

First Submitted

April 12, 2020

First Submitted That Met QC Criteria

April 12, 2020

First Posted (Actual)

April 15, 2020

Study Record Updates

Last Update Posted (Estimate)

March 10, 2023

Last Update Submitted That Met QC Criteria

March 9, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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