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Comparative Effectiveness in the Management of Irreversible Pulpitis | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGNA

Comparative Effectiveness in the Management of Irreversible Pulpitis

NCT04922229•University of Alabama at Birmingham

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.

Eligibility

Age

12 - 99 years

Sex

ALL

Healthy Volunteers

Yes

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.
+7 more criteria

Locations (1)

School of Dentistry, University of Alabama at Birmingham

Birmingham, Alabama, United States

Key Dates

Start Date

June 1, 2027

Primary Completion Date

June 30, 2030

Completion Date

December 31, 2031

Last Updated

February 17, 2026

Enrollment

138

ESTIMATED participants

Conditions

Irreversible Pulpitis

Interventions

RCT

PROCEDURE

Pulpotomy

PROCEDURE

Contacts

Sheila Turner, DDS

CONTACT

(205) 934-5045 jordan@uab.edu

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RECRUITINGNA

Postoperative Pain After Pulpotomy in Children Using Calcium Silicate Cements With and Without Laser Therapy

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Comparative Effectiveness in the Management of Irreversible Pulpitis

Inclusion Criteria

Exclusion Criteria

Postoperative Pain After Root Canal Obturation Using Bioceramic and Calcium Hydroxide Sealers

Postoperative Pain After Pulpotomy in Children Using Calcium Silicate Cements With and Without Laser Therapy

Intraligamentary vs Inferior Alveolar Nerve Block for Pulpitis: A Randomized Clinical Trial

Effectiveness of Pulpotomy in Symptomatic Permanent Teeth With Deep Caries Lesions

Postoperative Pain After Full Pulpotomy With TheraCal PT, Biodentin, and MTA

Assessment of L-PRF, Nanohydroxyapatite Combined With L-PRF Using Pulpotomy in Mature Mandibular First Molars