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

NCT05622266 | Unknown

• 1 other identifier: NFEC-2022-334
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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.

Conditions

Irreversible Pulpitis; Mature Teeth

Keywords

pulpotomy; root canal therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The pulp vitality in pulpotomy group

  From baseline to two years

• Survival rate of teeth

  From baseline to two years

Study Arms (2)

Pulpotomy

EXPERIMENTAL

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

Root Canal Therapy

ACTIVE COMPARATOR

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

Interventions

Pulpotomy PROCEDURE

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

Pulpotomy

Root Canal Therapy PROCEDURE

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

Root Canal Therapy

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Interventions

Pulpotomy; Root Canal Therapy

Intervention Hierarchy (Ancestors)

Endodontics; Dentistry

Study Officials

• Zhigang Guo, Doctor

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zilong Deng, Doctor

CONTACT

+86-020-62787149; zldeng@yeah.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2022
• First Posted: November 18, 2022
• Study Start: January 1, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2024
• Last Updated: November 18, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)