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Comparative Effectiveness in the Management of Irreversible Pulpitis

ConditionIrreversible Pulpitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-99
SponsorUniversity of Alabama at Birmingham

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • RCT

    Procedure/Surgery

    This is the standard of care for this diagnosis

  • Pulpotomy

    Procedure/Surgery

    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.

Treatment groups

138 Participants
are divided into 2 treatment groups
Group A: Root canal treatment (RCT)Active comparator 1 intervention
Group B: PulpotomyExperimental treatment 1 intervention

Trial outcomes

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

Time frame
From baseline through 2 years

Secondary outcomes

1

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

Time frame
From baseline to two years
2

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

Time frame
From baseline to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: