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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05622266
Enrollment
158
Registered
2022-11-18
Start date
2022-01-01
Completion date
2024-12-30
Last updated
2022-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irreversible Pulpitis, Mature Teeth

Keywords

pulpotomy, root canal therapy

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.

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.

Interventions

PROCEDUREPulpotomy

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

PROCEDURERoot Canal Therapy

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

Sponsors

Nanfang Hospital, Southern Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Success rate of pulpotomy and root canal therapyFrom baseline to two yearsThe teeth were asymptomatic. Clinical examination showed absence of clinical signs of pain and abscess or sinus tract. Radiographic assessment showed absence of periapical radiolucency.

Secondary

MeasureTime frameDescription
The pulp vitality in pulpotomy groupFrom baseline to two yearsThe pulpal vitality will be assessed through pulpal response to thermal and electric pulp tests in teeth treated with pulpotomy.
Survival rate of teethFrom baseline to two yearsSurvival rate of teeth will be evaluated by function and clinical symptoms.

Countries

China

Contacts

Primary ContactZilong Deng, Doctor
zldeng@yeah.net+86-020-62787149

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026