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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Irreversible Pulpitis Mature Teeth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pulpotomy

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

Group Type EXPERIMENTAL

Pulpotomy

Intervention Type PROCEDURE

The patients who are randomly assigned to the experimental group receive pulpotomy.

Root Canal Therapy

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.

Group Type ACTIVE_COMPARATOR

Root Canal Therapy

Intervention Type PROCEDURE

The patients who are randomly assigned to the Active Comparator group receive root canal therapy.

Interventions

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Pulpotomy

The patients who are randomly assigned to the experimental group receive pulpotomy.

Intervention Type PROCEDURE

Root Canal Therapy

The patients who are randomly assigned to the Active Comparator group receive root canal therapy.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes