Effectiveness of Pulpotomy in the Management of Mature Permanent Tooth With Irreversible Pulpits

Nanfang Hospital, Southern Medical University

Status: Enrolling

Conditions: Mature Teeth; Irreversible Pulpitis

Treatments: Procedure: Pulpotomy; Procedure: Root Canal Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05622266

NFEC-2022-334

Details and patient eligibility

About

This study is to evaluate the effectiveness of pulpotomy in mature permanent tooth with irreversible pulpits, and compare the clinical efficacy of pulpotomy and root canal therapy.

Full description

At present, root canal therapy ( RCT ) is still the main treatment for mature teeth diagnosed as irreversible pulpitis, but the teeth after RCT become non-vital, losing the immune defense mechanism and regeneration potential of pulp, which is not conducive to the long-term preservation of teeth. The traditional view is that mature permanent teeth with irreversible pulpitis are not indications for pulpotomy. However, with the deepening of pulp biology research and the availability of new pulp capping materials, the effect of pulpotomy is more predictable. Recent studies have shown that pulpotomy for irreversible pulpitis teeth can achieve good results, however, there is a lack of high-quality randomized controlled clinical studies, and the effect of pulpotomy compared with RCT studies rarely reported. Therefore, this project intends to explore the curative effect of pulpotomy on mature permanent teeth with irreversible pulpitis, and analyze the influence of age, tooth position and other factors on its curative effect, broaden the indications of pulpotomy, and establish the indications and standardized operation process of pulpotomy for mature permanent teeth with irreversible pulpitis.

Enrollment: 158 estimated patients

Sex: All

Ages: 18 to 59 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Intended to participate with this study, and provide informed assent/consent. Aged 18 and 59 years. At least one mature permanent teeth diagnosed as acute pulpitis or chronic pulpitis, and the teeth was in Nolla stage 9 and above by radiographic examination.

To be prepared to appear for follow-up.

Exclusion criteria

Allergic to any medications or materials necessary to complete the procedures. The teeth with severe coronal defect that find to be non-restorable. The teeth with full crown restoration. The teeth with root fracture or vertical root fractures. Patients with periodontitis. Patients who are undergoing orthodontic treatment. Patients with dental dysplasia or other oral genetic disorders. Women who are pregnant or lactating, or women who plan to become pregnant in the subsequent 2 years.

Patients with mental disorders. Patients with a history of systemic diseases that may alter immune function.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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158 participants in 2 patient groups

Pulpotomy

Experimental group

Description:

The removal of a small portion of the vital coronal pulp as a means of preserving the remaining coronal and radicular pulp tissues.

Treatment:

Procedure: Pulpotomy

Root Canal Therapy

Active Comparator group

Description:

The complete removal of the vital dental pulp. Any material or combination of materials placed inside a root canal for the purpose of obturating and sealing the canal space.

Treatment:

Procedure: Root Canal Therapy