Clinical trial NCT05622266: Effectiveness of Pulpotomy in the Management of Mature Permanent Tooth With Irreversible Pulpits
Official title: Comparative Effectiveness of Pulpotomy and Root Canal Therapy in the Management of Mature Permanent Tooth With Irreversible Pulpits: a Randomized Controlled Non-inferiority Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Irreversible Pulpitis
Mature Teeth
Keywords: pulpotomy
root canal therapy
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2022-11-18
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Success rate of pulpotomy and root canal therapy
timeFrame: From baseline to two years
Secondary outcomes:
measure: The pulp vitality in pulpotomy group
timeFrame: From baseline to two years
measure: Survival rate of teeth
timeFrame: From baseline to two years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Zhigang Guo, Doctor
role: PRINCIPAL_INVESTIGATOR
References: