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

Nanfang Hospital, Southern Medical University158 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

158

Conditions

Irreversible Pulpitis Mature Teeth

Interventions

PulpotomyPROCEDURE

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

Root Canal TherapyPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 59 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

Success rate of pulpotomy and root canal therapy

The teeth were asymptomatic. Clinical examination showed absence of clinical signs of pain and abscess or sinus tract. Radiographic assessment showed absence of periapical radiolucency.

Time frame: From baseline to two years

Secondary Outcomes

The pulp vitality in pulpotomy group

The pulpal vitality will be assessed through pulpal response to thermal and electric pulp tests in teeth treated with pulpotomy.

Time frame: From baseline to two years

Survival rate of teeth

Survival rate of teeth will be evaluated by function and clinical symptoms.

Time frame: From baseline to two years

Central Contacts

Zilong Deng, Doctor

CONTACT

+86-020-62787149 zldeng@yeah.net

Data from ClinicalTrials.gov

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