Endodontic infections (e.g. pulpitis, apical periodontitis)
Conditions
Interventions
Group 1: Group A:
Patients who have received a root canal filling with gutta-percha and TotalFill BC Sealer (KSS) using single cone technique
Group 2: Group B:
Patients who have received a root canal
Sponsors
Poliklinik für Zahnerhaltungskunde, Universitätsklinikum Heidelberg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • patients that received a root canal treatment of an upper or lower tooth at the Department of Conservative Dentistry, University Hospital Heidelberg or at the Zahnzentrum Messerschmidt • informed consent is available
Exclusion criteria
Exclusion criteria: • Patients whose general health condition is severely compromised, rendering them unable to tolerate treatment under standard conditions (e.g., severely immunosuppressed patients) • Female patients during pregnancy • Patients who refuse consent for recall or study participation • Teeth presenting with acute pain symptoms or abscess formation (acute or chronic) • Teeth with vertical root fractures • Teeth with bone loss extending into the apical third of the root • Teeth with endodontic-periodontal lesions • Teeth with Grade III furcation involvement • Teeth with progressive root resorptions (subject to case-by-case evaluation by the study director) • Teeth exhibiting condensing osteitis • Teeth treated with a mixture of different techniques (e.g., in a molar, one root filled with an MTA plug and the others with gutta-percha and calcium silicate sealer) • Teeth filled using root canal techniques or materials other than those specified for Groups A–C
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to evaluate the outcome of “success” in root canal fillings of teeth in groups A and B after two years, using different sealers and root canal filling techniques, and to compare the success rates between the groups. The classification into the "success" category is based on the following criteria: The classification of a tooth into the category "complete healing" is based on clinical and radiographic examination results, meaning the tooth must be clinically completely symptom-free and must not show radiographic signs of persistent inflammation (e.g., apical osteolysis or progressive resorption). For the radiographic assessment of the periapical situation, the Periapical Index (PAI), validated by Ørstavik in 1986, is used. The PAI score must either be 1 or 2. The PAI score for each study tooth (just before trepanation of the tooth, or on the day of trepanation, and on the day of the final recall) is recorded by a calibrated examiner. The minimum follow-up period for endodontic recalls, whose data are included in the statistical analysis, is set to 1 year (after the root canal filling). | — |
Secondary
| Measure | Time frame |
|---|---|
| In addition to the primary objective of comparing the “success” of root canal fillings between Group A and Group B after two years, the success rates of both groups will also be assessed after one year as well as after three, four, and five years. Furthermore, the success of root canal fillings in teeth of Group C will be evaluated in comparison to the gold standard (Group B) after one year and annually for at least five years following the root canal treatment. As additional secondary objectives, potential outcome predictors (POPs) identified in the literature—factors presumed to influence the long-term success of root canal–treated teeth—will be investigated. These predictors will be analyzed at the same time points as the primary objective: after two years, as well as after one, three, four, and five years. | — |
Countries
Germany
Contacts
Public ContactSarah Rampf
Poliklinik für Zahnerhaltungskunde, Universitätsklinikum Heidelberg
Outcome results
None listed