K04.0 K04.3
Conditions
Interventions
Group 1: Biodentine® capping material - tooth with irreversible pulpitis and carious opening of the pulp cavity (caries pofundissima)
- only posterior teeth of upper and lower jaws
Group 2: Coping
Sponsors
Poliklinik für ZahnerhaltungskundeUniversitätsklinikum Heidelberg
Eligibility
Sex/Gender
All
Age
6 Years to 100 Years
Inclusion criteria
Inclusion criteria: - Male and female patients in 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 underaged 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. - Teeth in which caries has extends into the pulp cavity (the pulp is clearly vital) and the pulp tissue of this tooth can be considered irreversibly inflamed - The tooth must be treatable and restorable under rubber dam isolation. - The treatment of the tooth after complete pulpotomy and subsequent direct capping of the pulp with ProRoot MTA® or Biodentine® and the restoration using composite must be done in the same treatment session.
Exclusion criteria
Exclusion criteria: - Teeth that are asymptomatic or show the clear symptoms of reversible pulpitisAnterior 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) of teeth with caries profundissima and the diagnosis of irreversible pulpitis after complete pulpotomy and treatment of the exposed pulp with Biodentine® or ProRoot MTA® with the primary target criterion "complete healing" after 1 year and then further annually until initially 5 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| As secondary objective criteria, the clinical factors: pulp canal obliteration (PCO) and discoloration of the capped teeth will be re-examined in the course of the usual recall examinations for 6 months, 12 months and then annually. In addition, the effect of various other potential prognostic factors will be investigated using logistic regression univariate and multivariate. | — |
Countries
Germany
Contacts
Public ContactJohannes Mente
Poliklinik für Zahnerhaltungskunde,Universitätsklinikum Heidelberg
Outcome results
None listed