K04.0 K04.3
Conditions
Interventions
Group 1: Arm 1A: Pulp capping material Biodentine® - asymptomatic teeth with profunde caries and accidental pulp exposure during caries excavation
– only posterior teeth
Group 2: Arm 1B: Pulp capp
Sponsors
Poliklinik für Zahnerhaltungskunde, Universitätsklinikum Heidelberg
Eligibility
Sex/Gender
All
Age
6 Years to No maximum
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany
Contacts
Public ContactJohannes Mente
Poliklinik für Zahnerhaltungskunde,Sektion Endodontologie und Dentale TraumatologieUniversitätsklinikum Heidelberg
Outcome results
None listed