Comparative Effectiveness in the Management of Irreversible Pulpitis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Irreversible Pulpitis
• Intervention / Treatment: Procedure: RCT; Procedure: Pulpotomy

Detailed Description

In this study, 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.

• Study Type: Interventional
• Enrollment (Estimated): 138
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sheila Turner, DDS; Phone Number: (205) 934-5045; Email: jordan@uab.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • School of Dentistry, University of Alabama at Birmingham
      • Contact: Sheila Turner; Phone Number: 205-934-5045; Email: jordan@uab.edu
      • Principal Investigator: Ashraf Fouad, DDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 99 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Maxillary or mandibular first or second mature permanent molars with carious lesions or restorations (excluding crowns), with signs and symptoms of symptomatic irreversible pulpitis (defined as spontaneous pulpal pain and cold hyperalgesia >30 seconds), and normal apical tissues.
• Tooth is responsive to cold and electrical pulp testing.
• Patients aged ≥12 years for first molars and ≥16 years for second molars.

Exclusion Criteria:

• Evidence of Pulp Necrosis or Apical Periodontitis, preoperatively or upon inspection of an exposure site
• 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 side.
• Teeth with radiographic evidence of internal, or external cervical, inflammatory or replacement root resorption, or with complete pulp canal obliteration.
• Radiographic evidence of PDL space wider than three times normal width
• 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 that require elective RCTx to place a post for restorative purposes.
• Teeth with no contralateral molars with normal pulp and periapical tissues for bite and pulp testing controls.
• Teeth in the pulpotomy group in which, following complete pulpotomy, bleeding does not stop after 10 minutes with 3-4% hypochlorite cotton pellet. These will be considered treatment failure and treated with RCTx.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Procedure: RCT; This is the standard of care for this diagnosis; Other Names: Endodontic therapy
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.	Procedure: Pulpotomy; 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.; Other Names: Therapeutic pulpotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with a successful outcome of pulpotomy versus RCT	A composite of clinical and radiographic findings and incidence of follow up procedures	From baseline through 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From baseline to two years
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	From baseline to 2 years

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Ashraf Fouad, DDS, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: June 4, 2021
• First Submitted That Met QC Criteria: June 4, 2021
• First Posted (Actual): June 10, 2021

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Pulpotomy; Vital Pulp Therapy
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pulpitis
• Other Study ID Numbers: IRB-300001234

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: To be determined

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No