Comparative Effectiveness in the Management of Irreversible Pulpitis

NCT ID: NCT04922229

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-12-01
• Study Completion Date: 2031-12-31

Brief Summary

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.

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.

Conditions

Irreversible Pulpitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Root canal treatment (RCT)

For cases with this diagnosis RCT is the standard of care and will be done according to clinically approved protocols

Group Type: ACTIVE_COMPARATOR

RCT

Intervention Type: PROCEDURE

This is the standard of care for this diagnosis

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.

Group Type: EXPERIMENTAL

Pulpotomy

Intervention Type: 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.

Interventions

RCT

This is the standard of care for this diagnosis

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

Endodontic therapy; Therapeutic 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 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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Ashraf Fouad

Professor and Chair

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ashraf Fouad, DDS

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

School of Dentistry, University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Central Contacts

Sheila Turner, DDS

Role: CONTACT

jordan@uab.edu

(205) 934-5045

Facility Contacts

Sheila Turner

Role: primary

jordan@uab.edu

(205) 934-5045

Other Identifiers

IRB-300001234

Identifier Type: -

Identifier Source: org_study_id