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

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.

Study Overview

• Status: Recruiting
• Conditions: Irreversible Pulpitis; Mature Teeth
• Intervention / Treatment: Procedure: Pulpotomy; Procedure: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 158
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zilong Deng, Doctor; Phone Number: +86-020-62787149; Email: zldeng@yeah.net

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Nanfang Hospital, Southern Medical University
      • Contact: Zilong Deng, Doctor; Phone Number: +86-020-62787149; Email: zldeng@yeah.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 57 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pulpotomy; The removal of a small portion of the vital coronal pulp as a means of preserving the remaining coronal and radicular pulp tissues.	Procedure: Pulpotomy; The patients who are randomly assigned to the experimental group receive pulpotomy.
Active Comparator: 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.	Procedure: Root Canal Therapy; The patients who are randomly assigned to the Active Comparator group receive root canal therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Survival rate of teeth	Survival rate of teeth will be evaluated by function and clinical symptoms.	From baseline to two years

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University
• Investigators: Principal Investigator: Zhigang Guo, Doctor, Nanfang Hospital of Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): December 30, 2023
• Study Completion (Anticipated): December 30, 2024

Study Registration Dates

• First Submitted: November 13, 2022
• First Submitted That Met QC Criteria: November 13, 2022
• First Posted (Actual): November 18, 2022

Study Record Updates

• Last Update Posted (Actual): November 18, 2022
• Last Update Submitted That Met QC Criteria: November 13, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: pulpotomy; root canal therapy
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pulpitis
• Other Study ID Numbers: NFEC-2022-334

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No