Long-term Evaluation of Direct Pulp Capping
Primary Purpose
Dental Pulp Capping, Dental Caries Extending to Pulp
Status
Unknown status
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Calcium Hydroxide (Ca(OH)2)
Mineral Trioxide Aggregate
Sponsored by
About this trial
This is an interventional treatment trial for Dental Pulp Capping
Eligibility Criteria
Inclusion Criteria:
- carious teeth that had no previous root canal treatment
- Pulpal diagnosis of normal or reversible pulpitis
Exclusion Criteria:
- History of irreversible pulpal pain
- Immature teeth
- Non restorable teeth
- Teeth with active periodontal disease
- History of any systemic disease
- Concurrent medication with systemic steroids, antibiotics, analgesics, immunomodulatory drugs or cytotoxics
Sites / Locations
- Dental health center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
calcium hydroxide direct pulp capping
MTA direct pulp capping
Arm Description
calcium hydroxide (Ca(OH)2 direct pulp capping will be performed in this group
Mineral Trioxide Aggregate (MTA) direct pulp capping will be performed in this group
Outcomes
Primary Outcome Measures
clinical vital pulp therapy success
Treatment was considered successful based on the absence of symptoms and signs Treatment was considered successful based on absence of symptoms and signs
Secondary Outcome Measures
Radiographic success
treatment could be further evaluated based on the absence of canal oblitration
Full Information
NCT ID
NCT03403985
First Posted
January 5, 2018
Last Updated
September 24, 2019
Sponsor
Jordan University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT03403985
Brief Title
Long-term Evaluation of Direct Pulp Capping
Official Title
Long-term Evaluation of Direct Pulp Capping Using Either Mineral Trioxid Aggregate or Calcium Hydroxide in Permanent Mature Teeth: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
June 28, 2017 (Actual)
Study Completion Date
June 2022 (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
No
5. Study Description
Brief Summary
Calcium hydroxide and mineral trioxide aggregate have been used in vital pulp therapy with variable outcomes recorded by different study. They will be compared when used for direct pulp capping in cariously exposed mature permanent teeth.
Detailed Description
Vital pulp therapy has the benefit of providing patients with a conservative treatment option with relatively low cost when compared to conventional root canal treatment and spares them possible post-treatment consequences that might occur. Vital pulp treatment in trauma cases is associated with high success rate but controversy still exists regarding vital pulp treatment in carious-exposed pulp.
The purpose of this study is to evaluate the success rate of direct pulp capping performed with MTA-Angelus® or calcium hydroxide in mechanical-exposed or carious-exposed mature permanent human teeth. Patients included in this study will be recruited from routine dental patients attending conservative clinics in JUST Dental Teaching Centre. Adult patients scheduled for routine conservative treatment involving caries removal and restoration with mechanical or carious pulp exposure will be invited to participate in this study.
A total of 80 carious human teeth with carious pulp exposure will be included in this randomized clinical study. Patients are among those scheduled for conservative dental treatment and end with pulp exposure. The patients and/or their parents will be asked to sign a consent form after receiving a detailed explanation about the study rationale, clinical procedures, and possible risks. The exposed teeth will be divided randomly into two experimental groups (n=40) according to the dressing materials; MTA-Angelus® or calcium hydroxide, then teeth will be restored with permanent filling. Teeth will be reviewed recording any signs and symptoms. Patients will be reviewed in 1 week, 3 months and yearly after. MTA-Angelus and calcium hydroxide are anticipated to be biocompatible and induce hard tissue barrier. This project will reveal if tested materials are presented with promising profile upon using as direct pulp capping dressing in mechanical and carious-exposed pulp.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Pulp Capping, Dental Caries Extending to Pulp
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Retrospective clinical trial
Masking
Participant
Masking Description
patients are not aware about type of capping material used
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
calcium hydroxide direct pulp capping
Arm Type
Experimental
Arm Description
calcium hydroxide (Ca(OH)2 direct pulp capping will be performed in this group
Arm Title
MTA direct pulp capping
Arm Type
Experimental
Arm Description
Mineral Trioxide Aggregate (MTA) direct pulp capping will be performed in this group
Intervention Type
Drug
Intervention Name(s)
Calcium Hydroxide (Ca(OH)2)
Other Intervention Name(s)
Ca(OH)2
Intervention Description
Ca(OH)2 will be used in this group
Intervention Type
Drug
Intervention Name(s)
Mineral Trioxide Aggregate
Other Intervention Name(s)
MTA
Intervention Description
MTA will be used in this group
Primary Outcome Measure Information:
Title
clinical vital pulp therapy success
Description
Treatment was considered successful based on the absence of symptoms and signs Treatment was considered successful based on absence of symptoms and signs
Time Frame
from date of randomization until failure reported for up to 100 months
Secondary Outcome Measure Information:
Title
Radiographic success
Description
treatment could be further evaluated based on the absence of canal oblitration
Time Frame
from date of randomization until failure reported for up to 100 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
carious teeth that had no previous root canal treatment
Pulpal diagnosis of normal or reversible pulpitis
Exclusion Criteria:
History of irreversible pulpal pain
Immature teeth
Non restorable teeth
Teeth with active periodontal disease
History of any systemic disease
Concurrent medication with systemic steroids, antibiotics, analgesics, immunomodulatory drugs or cytotoxics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lama Awawdeh, PhD
Organizational Affiliation
Jordan University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dental health center
City
Irbid
Country
Jordan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Long-term Evaluation of Direct Pulp Capping
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