Comparative Effectiveness in the Management of Irreversible Pulpitis

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT04922229
Status
Not Yet Recruiting

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Conditions

  • Irreversible Pulpitis

Eligibility Criteria

Sex
ALL
Age
12 Years - 99 Years
Healthy Volunteers
Accepted

Interventions

  • RCT — PROCEDURE
    This is the standard of care for this diagnosis
  • Pulpotomy — PROCEDURE
    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.

Study Details

This project addresses a central question within the practice of dentistry: Is a pulpotomy procedure effective in the treatment of a tooth with symptomatic irreversible pulpitis and normal periapex? In addition, the project seeks to identify clinical and molecular biomarkers that are predictive of the success of pulpotomy.

Key Dates

Start date
Jun 1, 2027
Status verified
Feb 2026
Primary completion
Jun 30, 2030
Completion
Dec 31, 2031

Study Design

Enrollment
138 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Root canal treatment (RCT)
    For cases with this diagnosis RCT is the standard of care and will be done according to clinically approved protocols
  • Experimental: Pulpotomy
    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.

Primary Outcome Measure

Percentage of patients with a successful outcome of pulpotomy versus RCT [ Time Frame: From baseline through 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
School of Dentistry, University of Alabama at BirminghamBirminghamAlabama35233
Sheila Turner
[email protected]
(205) 934-5045
Ashraf Fouad, DDS (PRINCIPAL_INVESTIGATOR)

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By research site
School of Dentistry, University of Alabama at Birmingham· Birmingham, AL

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