Comparative Effectiveness in the Management of Irreversible Pulpitis
Primary Purpose
Irreversible Pulpitis
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RCT
Pulpotomy
Sponsored by
About this trial
This is an interventional treatment trial for Irreversible Pulpitis focused on measuring Vital Pulp Therapy, Pulpotomy
Eligibility Criteria
Inclusion Criteria:
- Maxillary or mandibular first or second mature permanent molars with carious lesions or restorations (excluding crowns), with signs and symptoms of reversible or irreversible pulpitis, requiring treatment, where pulp exposure is detectable upon excavation.
- Tooth is responsive to cold and electrical pulp testing, with or without hyperalgesia
- Patients aged ≥10y for first molars and ≥16y for second molars
Exclusion Criteria:
- Evidence of Pulp Necrosis or Apical Periodontitis, preoperatively or upon inspection of an exposure site
- Absence of a contralateral molar teeth
- Teeth that are badly broken down and/or are not restorable
- Teeth with mechanical allodynia assessed by registering bite force that is at least 50N lower than the contralateral tooth
- Teeth with radiographic evidence of internal, or external cervical, inflammatory or replacement root resorption, or with pulp canal obliteration
- Teeth with no clinical evidence of pulp exposure upon excavation
- Radiographic evidence of PDL space wider than three times normal width on preoperative CBCT
- Clinical evidence of swelling or sinus tract
- Periodontal pocket probing depth ≥5 mm in any site around the tooth
- Clinical evidence of cracks connecting mesial and distal surfaces and/or extending in pulp chamber or associated with periodontal pockets ≥5 mm
- History of taking centrally acting drugs (e.g., tricyclic antidepressants), which interfere with the release of pain mediators and/or modify pain experience, within the previous 6 months.
- Use of medications that affect the host response such as methotrexate; corticosteroids or cyclosporin
- Patients on immunosuppressive agents, chronic corticosteroid use, autoimmune disease, or other immunocompromising diseases or medications
- Patients who require IV sedation or general anesthesia for their dental treatment
- Teeth with full coverage crowns
- Teeth undergoing active orthodontic movement
- Teeth in the VPT group that require intra-pulpal anesthesia for completion of treatment will be considered a treatment failure and treated with RCTx.
- Teeth that require elective RCTx, regardless of pulpal diagnosis, for restorative purposes.
- Teeth in the VPT group in which, following complete pulpotomy, bleeding does not stop after 10 minutes with 3% hypochlorite cotton pellet. These will be considered treatment failure and treated with RCTx.
- Patients who know that they are or may be pregnant at time of treatment. At the 2-year follow up, if they are pregnant the CBCT will be delayed until they have their baby.
Sites / Locations
- School of Dentistry, University of Alabama at Birmingham
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Root canal treatment (RCT)
Pulpotomy
Arm Description
For cases with this diagnosis RCT is the standard of care and will be done according to clinically approved protocols
Pulpotomy with tricalcium silicates has shown high clinical success in these cases. However, it is not known how this success compares to RCT under similar conditions and with an intent-to-treat study design, which will be employed here.
Outcomes
Primary Outcome Measures
Percentage of patients with a successful outcome of pulpotomy versus RCT
A composite of clinical and radiographic findings and incidence of follow up procedures
Secondary Outcome Measures
Determine prognostic validity of preoperative hyperalgesia in determining the outcome of pulpotomy
Neurosensory measurements of preoperative signs and symptoms will be measured and correlated with the outcome of pulpotomy
Determine prognostic validity of a set of pulpal inflammatory proteins in determining the outcome of pulpotomy
Protein analysis at the time of treatment will be correlated with the outcome of pulpotomy
Full Information
NCT ID
NCT04922229
First Posted
June 4, 2021
Last Updated
August 14, 2023
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT04922229
Brief Title
Comparative Effectiveness in the Management of Irreversible Pulpitis
Official Title
Comparative Effectiveness in the Management of Irreversible Pulpitis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 15, 2023 (Anticipated)
Primary Completion Date
December 31, 2028 (Anticipated)
Study Completion Date
December 31, 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
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
This project addresses a central question within the practice of dentistry: What is the optimal treatment of carious pulp exposure, in a tooth with a vital pulp and normal periapex. In addition, the project seeks to identify clinical and laboratory findings that would be predictive of success of vital pulp therapy.
Detailed Description
In this study, 138 patients will be randomized to two groups. All patients will have a diagnosis of irreversible pulpitis with normal apical tissues. The groups will be root canal treatment and pulpotomy. The patients will be followed clinically and radiographically for 2 years following the treatment. Predictors of the outcome of pulpotomy will be clinical and laboratory-based parameters.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irreversible Pulpitis
Keywords
Vital Pulp Therapy, Pulpotomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
138 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Root canal treatment (RCT)
Arm Type
Active Comparator
Arm Description
For cases with this diagnosis RCT is the standard of care and will be done according to clinically approved protocols
Arm Title
Pulpotomy
Arm Type
Experimental
Arm Description
Pulpotomy with tricalcium silicates has shown high clinical success in these cases. However, it is not known how this success compares to RCT under similar conditions and with an intent-to-treat study design, which will be employed here.
Intervention Type
Procedure
Intervention Name(s)
RCT
Other Intervention Name(s)
Endodontic therapy
Intervention Description
This is the standard of care for this diagnosis
Intervention Type
Procedure
Intervention Name(s)
Pulpotomy
Other Intervention Name(s)
Therapeutic pulpotomy
Intervention Description
For cases with normal apical tissues, pulpotomy using tricalcium silicates has been shown to have high clinical success. Either partial or complete pulpotomy will be performed depending on the size of pulp exposure.
Primary Outcome Measure Information:
Title
Percentage of patients with a successful outcome of pulpotomy versus RCT
Description
A composite of clinical and radiographic findings and incidence of follow up procedures
Time Frame
From baseline through 2 years
Secondary Outcome Measure Information:
Title
Determine prognostic validity of preoperative hyperalgesia in determining the outcome of pulpotomy
Description
Neurosensory measurements of preoperative signs and symptoms will be measured and correlated with the outcome of pulpotomy
Time Frame
From baseline to two years
Title
Determine prognostic validity of a set of pulpal inflammatory proteins in determining the outcome of pulpotomy
Description
Protein analysis at the time of treatment will be correlated with the outcome of pulpotomy
Time Frame
From baseline to 2 years
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Maxillary or mandibular first or second mature permanent molars with carious lesions or restorations (excluding crowns), with signs and symptoms of reversible or irreversible pulpitis, requiring treatment, where pulp exposure is detectable upon excavation.
Tooth is responsive to cold and electrical pulp testing, with or without hyperalgesia
Patients aged ≥10y for first molars and ≥16y for second molars
Exclusion Criteria:
Evidence of Pulp Necrosis or Apical Periodontitis, preoperatively or upon inspection of an exposure site
Absence of a contralateral molar teeth
Teeth that are badly broken down and/or are not restorable
Teeth with mechanical allodynia assessed by registering bite force that is at least 50N lower than the contralateral tooth
Teeth with radiographic evidence of internal, or external cervical, inflammatory or replacement root resorption, or with pulp canal obliteration
Teeth with no clinical evidence of pulp exposure upon excavation
Radiographic evidence of PDL space wider than three times normal width on preoperative CBCT
Clinical evidence of swelling or sinus tract
Periodontal pocket probing depth ≥5 mm in any site around the tooth
Clinical evidence of cracks connecting mesial and distal surfaces and/or extending in pulp chamber or associated with periodontal pockets ≥5 mm
History of taking centrally acting drugs (e.g., tricyclic antidepressants), which interfere with the release of pain mediators and/or modify pain experience, within the previous 6 months.
Use of medications that affect the host response such as methotrexate; corticosteroids or cyclosporin
Patients on immunosuppressive agents, chronic corticosteroid use, autoimmune disease, or other immunocompromising diseases or medications
Patients who require IV sedation or general anesthesia for their dental treatment
Teeth with full coverage crowns
Teeth undergoing active orthodontic movement
Teeth in the pulpotomy group that require intra-pulpal anesthesia for completion of treatment will be considered a treatment failure and treated with RCTx.
Teeth that require elective RCTx, regardless of pulpal diagnosis, for restorative purposes.
Teeth in the pulpotomy group in which bleeding does not stop after 10 minutes with 3% hypochlorite cotton pellet. These will be considered treatment failure and treated with RCTx.
Patients who know that they are or may be pregnant at time of treatment. At the 2-year follow up, if they are pregnant the CBCT will be delayed until they have their baby.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sheila Turner, DDS
Phone
(205) 934-5045
Email
jordan@uab.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashraf Fouad, DDS
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Dentistry, University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheila Turner
Phone
205-934-5045
Email
jordan@uab.edu
First Name & Middle Initial & Last Name & Degree
Ashraf Fouad, DDS
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
To be determined
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Comparative Effectiveness in the Management of Irreversible Pulpitis
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