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Pulpotomy as a Treatment of Irreversible Pulpitis

Pulpotomy as a Permanent Treatment of Irreversible Pulpitis on Mature Molar Teeth - a Pilot Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02920606
Enrollment
100
Registered
2016-09-30
Start date
2016-04-30
Completion date
2024-06-30
Last updated
2021-03-11

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

Conditions

Irreversible Pulpitis

Keywords

pulpotomy, pulpitis, mature tooth, tricalcium silicate

Brief summary

The procedure currently recommended for the treatment of irreversible pulpitis is the endodontic treatment, i.e. the complete elimination of the pulp, disinfection and obturation of the whole root canal system. The emergency procedure consists of a pulpotomy, followed at an ulterior appointment by the root canal treatment. The purpose of the present pilot study is to evaluate the feasibility of performing the pulpotomy as a permanent treatment in mature molars. If hemostasis can be achieved after removing the coronal part of the pulp, a tricalcium silicate cement will be directly applied on the remaining pulp at the root canal entrances. A short-term follow-up will be performed at one week by evaluating the pain relief of the patient. Long-term success will then be evaluated every year by verifying the absence of periapical radiolucency on the x-ray as well as the absence of clinical symptoms and signs. A standard root canal procedure will serve as control. During the pulpotomy treatment, blood sample with microcapillary will be performed. We will analyze a ratio of pro-inflammatory and anti-inflammatory cytokines.

Interventions

PROCEDUREPulpotomy
PROCEDUREEndodontic treatment

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Good general health * Not pregnant women * At least one permanent molar in irreversible pulpitis * Adult patient * Mentally competent

Exclusion criteria

* Periapical radiolucency * Periodontical probing * Root fracture * Sinus tract * Swelling or mobility * External or/and internal resorption * Open apicies * A non restorable tooth

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of the success rate (%) at 1 yearFollow up at 1 year for all patients included in the studyto evaluate the treatment success defined as the absence of clinical symptoms (pain, sinus tract..) and the absence of radiological symptoms (periapical radiolucency), in order to point the non-inferiority of the pulpotomy compared with the conventional treatment

Secondary

MeasureTime frameDescription
Evaluation of the correlation between pro/anti-inflammatory cytokines and the success of pulpotomyFollow up at 1 year for all patients included in the studyDuring the pulpotomy treatment, blood samples with microcapillaries will be performed. We will analyze a ratio of pro-inflammatory and anti-inflammatory cytokines.

Other

MeasureTime frameDescription
Evaluation of the success rate (%) up to 4 yearsFollow up at 4 years for all patients included in the test groupto evaluate the treatment success defined as the absence of clinical symptoms (pain, sinus tract..) and the absence of radiological symptoms (periapical radiolucency), in order to point the non-inferiority of the pulpotomy compared with the conventional treatment

Outcome results

None listed

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