NCT05622266

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 158 (estimated)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

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.

Conditions

• Irreversible Pulpitis
• Mature Teeth

Interventions

Type	Name	Description
PROCEDURE	Pulpotomy	The patients who are randomly assigned to the experimental group receive pulpotomy.
PROCEDURE	Root Canal Therapy	The patients who are randomly assigned to the Active Comparator group receive root canal therapy.

Timeline

• Start date: 2022-01-01
• Primary completion: 2023-12-30
• Completion: 2024-12-30
• First posted: 2022-11-18
• Last updated: 2022-11-18

Locations

1 site across 1 country: China