Outcome of Full Pulpotomy Using Calcium Silicate Based Materials (pulpotomy)
Primary Purpose
Carious Teeth
Status
Unknown status
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
MTA pulpotomy
Sponsored by
About this trial
This is an interventional treatment trial for Carious Teeth focused on measuring teeth, caries, pulpotomy, MTA, biodentine, bioceramic
Eligibility Criteria
Inclusion Criteria:
- Mature permanent tooth with carious lesion exposing the pulp,
- Positive response to cold test
- Clinical Diagnosis of reversible or irreversible pulpitis
- Restorable tooth by direct restoration or crown
- Healthy patient
Exclusion Criteria:
- Non vital teeth
- Teeth without pulp exposure
- Inability to achieve hemostasis within 10 min after pulpotomy
- Non restorable teeth or teeth that require post and core restoration
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
Active Comparator
Active Comparator
Active Comparator
Arm Label
MTA pulpotomy
Biodentine pulpotomy
Bioceramic pulpotomy
Arm Description
Tooth will receive MTA & resin composite restoration
Tooth will receive Biodentine & resin composite restoration
Tooth will receive Bioceramic & resin composite restoration
Outcomes
Primary Outcome Measures
Degree of pain relief after treatment compared to preoperative pain level
Absence of symptoms or significant pain reduction within the first week after treatment as measured on a numerical scale from 0 to 10 where zero means no pain and 10 is the most sever pain. Visual analogue scale will be also used.
Secondary Outcome Measures
Radiographic normalcy
Absence of pathology in the root and the bone surrounding the apex
Full Information
NCT ID
NCT04345263
First Posted
April 9, 2020
Last Updated
September 15, 2021
Sponsor
Jordan University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT04345263
Brief Title
Outcome of Full Pulpotomy Using Calcium Silicate Based Materials
Acronym
pulpotomy
Official Title
Outcome of Full Pulpotomy in Permanent Teeth With Carious Pulp Exposure, a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
May 2, 2018 (Actual)
Study Completion Date
May 2, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
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
Permanent teeth with carious pulp exposure and indicated for full pulpotomy will be treated using three different materials using aseptic technique and will be subsequently followed up clinically and radiographically at 6 months, 1 year and yearly up to 5 years.
Detailed Description
The target sample size is 150 patients medically fit, having vital teeth with carious pulp exposure and complaining of pain.
The patients tooth will receive full pulpotomy under aseptic conditions and it will be randomly assigned to one of 3 calcium silicate based materials namely, (Mineral trioxide Aggregate (MTA), Biodentine, and Bioceramic for capping the full pulpotomy followed by resin composite restoration.
Follow up for pain levels will be done during the first week.
clinical and radiographic examination will be done at 6 months, 1 year and yearly up to 5 years.
Success of the procedure includes absence of clinical signs and symptoms, with absence of pathology in the root and periapex on periapical radiographs.
The 3 materials will be compared in terms of clinical and radiographic outcomes.
demographic data of the three groups will be also compared
predictive factors of success will be also analyzed
tooth color changes will be also measured using vita easy shade and will compared between the groups at 6 months and 1 year.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carious Teeth
Keywords
teeth, caries, pulpotomy, MTA, biodentine, bioceramic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Patient unaware of the material to be used, care provider will be given the material after performing full pulpotomy . Tooth crown will be masked during assessment of radiographs
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MTA pulpotomy
Arm Type
Active Comparator
Arm Description
Tooth will receive MTA & resin composite restoration
Arm Title
Biodentine pulpotomy
Arm Type
Active Comparator
Arm Description
Tooth will receive Biodentine & resin composite restoration
Arm Title
Bioceramic pulpotomy
Arm Type
Active Comparator
Arm Description
Tooth will receive Bioceramic & resin composite restoration
Intervention Type
Procedure
Intervention Name(s)
MTA pulpotomy
Other Intervention Name(s)
Biodentine pulpotomy and Bioceramic pulpotomy
Intervention Description
Cutting the coronal portion of the pulp to the level of canal orifices and applying the dressing and restoration
Primary Outcome Measure Information:
Title
Degree of pain relief after treatment compared to preoperative pain level
Description
Absence of symptoms or significant pain reduction within the first week after treatment as measured on a numerical scale from 0 to 10 where zero means no pain and 10 is the most sever pain. Visual analogue scale will be also used.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Radiographic normalcy
Description
Absence of pathology in the root and the bone surrounding the apex
Time Frame
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:
Mature permanent tooth with carious lesion exposing the pulp,
Positive response to cold test
Clinical Diagnosis of reversible or irreversible pulpitis
Restorable tooth by direct restoration or crown
Healthy patient
Exclusion Criteria:
Non vital teeth
Teeth without pulp exposure
Inability to achieve hemostasis within 10 min after pulpotomy
Non restorable teeth or teeth that require post and core restoration
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
Detailed participants data will be released within the publications resulting from the trial with reference to the registration number of the study. If further details are required the principal investigator. can be contacted via email.
Citations:
PubMed Identifier
35152464
Citation
Taha NA, Al-Rawash MH, Imran ZA. Outcome of full pulpotomy in mature permanent molars using 3 calcium silicate-based materials: A parallel, double blind, randomized controlled trial. Int Endod J. 2022 May;55(5):416-429. doi: 10.1111/iej.13707. Epub 2022 Mar 17.
Results Reference
derived
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Outcome of Full Pulpotomy Using Calcium Silicate Based Materials
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