Pulpotomy as a Treatment of Irreversible Pulpitis

Irreversible Pulpitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02920606
• Other study ID #: Pulpotomie-1
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 2016
• Est. completion date: June 2024

Study information

• Verified date: March 2021
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: June 2024
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Irreversible Pulpitis
• Pulpitis

Intervention

Procedure:
• Pulpotomy

• Endodontic treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluation of the success rate (%) up to 4 years	to 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	Follow up at 4 years for all patients included in the test group
Primary	Evaluation of the success rate (%) at 1 year	to 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	Follow up at 1 year for all patients included in the study
Secondary	Evaluation of the correlation between pro/anti-inflammatory cytokines and the success of pulpotomy	During the pulpotomy treatment, blood samples with microcapillaries will be performed. We will analyze a ratio of pro-inflammatory and anti-inflammatory cytokines.	Follow up at 1 year for all patients included in the study