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.
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: March 31, 2027
In this study, 120 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 vital pulp therapy (VPT). The patients will be followed clinically and radiographically for 2 years following the treatment. Predictors of the outcome of VPT will be clinical and laboratory-based parameters.
- Procedure: RCT
- This is the standard of care for this diagnosis
- Procedure: VPT
- For cases with normal apical tissues, this VPT using tricalcium silicates has been shown to have high clinical success. Either pulpotomy of direct pulp capping will be performed depending on the size of pulp exposure.
Arms, Groups and Cohorts
- 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: Vital Pulp Therapy (VPT)
- VPT 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.
Clinical Trial Outcome Measures
- Percentage of patients with a successful outcome of VPT versus RCT
- Time Frame: From baseline through 2 years
- A composite of clinical and radiographic findings and incidence of follow up procedures
- Determine prognostic validity of preoperative hyperalgesia in determining the outcome of VPT
- Time Frame: From baseline to two years
- Neurosensory measurements of preoperative signs and symptoms will be measured and correlated with the outcome of VPT
- Determine prognostic validity of a set of pulpal inflammatory proteins in determining the outcome of VPT
- Time Frame: From baseline to 2 years
- Protein analysis at the time of treatment will be correlated with the outcome of VPT
Participating in This Clinical Trial
- 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 probable 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 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 for restorative purposes. – Teeth in the VPT group in which, following complete pulpotomy, bleeding does not stop after 10 minutes with 4% 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.
Gender Eligibility: All
Minimum Age: 10 Years
Maximum Age: 99 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- University of Alabama at Birmingham
- Provider of Information About this Clinical Study
- Principal Investigator: Ashraf Fouad, Professor and Chair – University of Alabama at Birmingham
- Overall Official(s)
- Ashraf Fouad, DDS, Principal Investigator, University of Alabama at Birmingham
- Overall Contact(s)
- Sheila Turner, DDS, (205) 934-5045, firstname.lastname@example.org
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