Tooth Discoloration Induced by Pulpotomy Materials
Primary Purpose
Tooth Discoloration
Status
Active
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Pulpotomy
Sponsored by
About this trial
This is an interventional treatment trial for Tooth Discoloration focused on measuring Pulpotomy, MTA, Biodentine, Bioceramic, discoloration
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
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
NCT ID
NCT04346849
First Posted
April 12, 2020
Last Updated
March 9, 2023
Sponsor
Jordan University of Science and Technology
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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