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Tooth Discoloration Induced by Pulpotomy Materials

Primary Purpose

Tooth Discoloration

Status
Active
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Pulpotomy
Sponsored by
Jordan University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Discoloration focused on measuring Pulpotomy, MTA, Biodentine, Bioceramic, discoloration

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dental teaching centre Faculty Of Dentistry
  • Jordan University of science and technology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

MTA pulpotomy

Biodentine pulpotomy

Bioceramic pulpotomy

Arm Description

Teeth receiving pulpotomy using MTA

Teeth receiving pulpotomy using Biodentine

Teeth receiving pulpotomy using Bioceramic

Outcomes

Primary Outcome Measures

Tooth color change
Darkening in tooth color shade after placement of the calcium silicate based material

Secondary Outcome Measures

Full Information

First Posted
April 12, 2020
Last Updated
March 9, 2023
Sponsor
Jordan University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT04346849
Brief Title
Tooth Discoloration Induced by Pulpotomy Materials
Official Title
Tooth Discoloration Induced by Different Calcium Silicate Based Materials: in Vivo Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2, 2017 (Actual)
Primary Completion Date
May 2, 2018 (Actual)
Study Completion Date
May 2, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jordan University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Discoloration
Keywords
Pulpotomy, MTA, Biodentine, Bioceramic, discoloration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantInvestigatorOutcomes 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
Allocation
Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MTA pulpotomy
Arm Type
Experimental
Arm Description
Teeth receiving pulpotomy using MTA
Arm Title
Biodentine pulpotomy
Arm Type
Experimental
Arm Description
Teeth receiving pulpotomy using Biodentine
Arm Title
Bioceramic pulpotomy
Arm Type
Experimental
Arm Description
Teeth receiving pulpotomy using Bioceramic
Intervention Type
Procedure
Intervention Name(s)
Pulpotomy
Intervention Description
Cutting the coronal portion of the pulp and application of a calcium silicate based material followed by restoration
Primary Outcome Measure Information:
Title
Tooth color change
Description
Darkening in tooth color shade after placement of the calcium silicate based material
Time Frame
Immediate, 6 months, 1 year and yearly up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nessrin Taha, DCD
Organizational Affiliation
Jordan University of Science and Technology
Official's Role
Study Chair
Facility Information:
Facility Name
Dental teaching centre Faculty Of Dentistry
City
IRbid
ZIP/Postal Code
21110
Country
Jordan
Facility Name
Jordan University of science and technology
City
Irbid
ZIP/Postal Code
22110
Country
Jordan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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

Learn more about this trial

Tooth Discoloration Induced by Pulpotomy Materials

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