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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05622266
Other study ID # NFEC-2022-334
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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