Outcome of partial pulpotomy and vital pulp therapy of teeth using biodentine compared to mineral trioxide aggregates (MTA).

Not Applicable

Recruiting

• Conditions: K04.0; K04.3; Pulpitis; Abnormal hard tissue formation in pulp

• Registration Number: DRKS00022302
• Lead Sponsor: Poliklinik für Zahnerhaltungskunde, Universitätsklinikum Heidelberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-10
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Male and female patients of the age = 6 years
- Patients from the Department of Conservative Dentistry at Clinic for Oral, Dental and Maxillofacial Diseases, University Hospital Heidelberg or from one of the cooperating trial centres
- Present declaration of consent of the patient to participate in the study; in the case of underage patients, the consent of the legal guardian/legal representative must also be present
- Adult patients must be able to give consent
- Teeth in which (the clearly vital) pulp of a tooth with a caries extending into the pulp resulting in pulp exposure during caries excavation.
- The pulp tissue of the treated tooth must be classified either as completely asymptomatic or reversibly inflamed (reversible pulpitis).
- The tooth must be treatable and restorable under rubber dam isolation.
- The restoration of the tooth after partial pulpotomy and subsequent direct pulp capping with ProRoot MTA® or Biodentine® using composite must be completed within 24 hours.

Exclusion Criteria

- Teeth with irreversible pulpitis
- Anterior teeth FDI: 13-23 and 33-43
- Primary teeth
- Patients whose state of health is reduced to such an extent that they are not able to cope with the usual stress (e.g. immunocompromised patients)
- Patients for the period of their pregnancy
- Patients who have not yet reached the age of 6
- Patients who do not give their consent to participate in the study
- Teeth that have a longitudinal fracture at the time of the treatment with partial pulpotomy
- Teeth which, at the time of the treatment, showed bone loss down to the apical third of the root, teeth with a perio-endo-lesion or a teeth with a degree of mobility of 3
- Teeth that showed at the periapical radiograph a periapical index PAI=3 at the day of the treatment with partial pulpotomy
- Teeth in which an internal or external tooth/root resorption is already evident at day of the treatment with partial pulpotomy

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The main objective of the study is a comparative evaluation of the clinically and radiographically evaluated success rates (outcome) with the primary target criterion complete healing after 1 year and then annually until 5 years after partial pulpotomy and treatment of the exposed pulp with Biodentine® or ProRoot MTA®, taking into account the inflammatory status of the pulp tissue (asymptomatic pulp or reversible pulpitis) on the day of the partial pulpotomy.

Secondary Outcome Measures

Name	Time	Method
As secondary objective criteria, the clinical factors: obliteration of the pulp and discoloration of the pulp capped teeth should be examined for 6 months, 12 months and then annually in the course of the usual follow-up examinations. In addition, the effect of various other potential prognostic factors will be investigated using logistic regression.