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

Irreversible Pulpitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05622266
• Other study ID #: NFEC-2022-334
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: September 2022
• Source: Nanfang Hospital of Southern Medical University
• Contact: Zilong Deng, Doctor
• Phone: +86-020-62787149
• Email: zldeng[@]yeah.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 158
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

• Irreversible Pulpitis
• Mature Teeth
• Pulpitis

Intervention

Procedure:
• Pulpotomy
The patients who are randomly assigned to the experimental group receive pulpotomy.
• Root Canal Therapy
The patients who are randomly assigned to the Active Comparator group receive root canal therapy.

Locations

Country	Name	City	State
China	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From baseline to two years
Secondary	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.	From baseline to two years
Secondary	Survival rate of teeth	Survival rate of teeth will be evaluated by function and clinical symptoms.	From baseline to two years