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NCT Number: NCT04922229

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.

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Key information

Age range

12 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Dentistry, University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location contact

Ashraf Fouad, DDS

PRINCIPAL_INVESTIGATOR

Sheila Turner

CONTACT

[email protected]

(205) 934-5045

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RCT

Procedure

This is the standard of care for this diagnosis

Other names: Endodontic therapy

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.

Other names: Therapeutic pulpotomy

Primary outcomes

  1. Percentage of patients with a successful outcome of pulpotomy versus RCT

    Time frame: From baseline through 2 years

    A composite of clinical and radiographic findings and incidence of follow up procedures

Secondary outcomes

  1. Determine prognostic validity of preoperative hyperalgesia in determining the outcome of pulpotomy

    Time frame: From baseline to two years

    Neurosensory measurements of preoperative signs and symptoms will be measured and correlated with the outcome of pulpotomy

  2. Determine prognostic validity of a set of pulpal inflammatory proteins in determining the outcome of pulpotomy

    Time frame: From baseline to 2 years

    Protein analysis at the time of treatment will be correlated with the outcome of pulpotomy

Study contacts

Contact information is provided by the study sponsor or research team.

Sheila Turner, DDS

CONTACT

[email protected]

(205) 934-5045

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Important dates

Study start
2027
Primary completion
2030
Study completion
2031
First posted
Jun 10, 2021
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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