Comparative Effectiveness in the Management of Irreversible Pulpitis

NCT04922229 | Not Yet Recruiting DMC

• 1 other identifier: IRB-300001234
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Irreversible Pulpitis

Keywords

Pulpotomy; Vital Pulp Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Determine prognostic validity of preoperative hyperalgesia in determining 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

  From baseline to 2 years

Study Arms (2)

Root canal treatment (RCT)

ACTIVE COMPARATOR

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

Procedure: RCT

Pulpotomy

EXPERIMENTAL

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

Interventions

RCT PROCEDURE

This is the standard of care for this diagnosis

Also known as: Endodontic therapy

Root canal treatment (RCT)

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.

Also known as: Therapeutic pulpotomy

Pulpotomy

Eligibility Criteria

• Age: 12 Years - 99 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

School of Dentistry, University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Interventions

Dental Implantation, Endosseous, Endodontic; Pulpotomy

Intervention Hierarchy (Ancestors)

Dental Implantation, Endosseous; Dental Implantation; Oral Surgical Procedures, Preprosthetic; Oral Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Endodontics; Dentistry; Prosthodontics

Study Officials

• Ashraf Fouad, DDS

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheila Turner, DDS

CONTACT

(205) 934-5045; jordan@uab.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 10, 2021
• Study Start (Estimated): June 1, 2027
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): December 31, 2031
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)