K04.0
Conditions
Interventions
Group 1: Patient receives novel root filling device (investigational medical device, IMD)
Group 2: Patient receives a standard treatment based on single-cone gutta-percha obturation (Dentsply Sirona
Comparator)
Sponsors
Endodont GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: IN01 Written informed consent prior to any study related procedures IN02 Patient requiring a primary root canal obturation on a single- or multi-rooted tooth
Exclusion criteria
Exclusion criteria: EX01 Patient with one or more documented contraindication to endodontic treatment, EX02 Contraindication to the use of calcium silicate root canal sealer, such as an immature tooth or a known hypersensitivity to one component of the sealer formula, EX03 Known allergy to local anaesthetics or latex EX04 Patient taking anti-pain, anti-inflammatory treatment regularly for another pathology, in particular such pathologies that affect bone regeneration (e.g. prior radiation, bisphosphonate therapy) EX05 Patient with an uncontrolled systemic disease such as diabetes or thyroid disorders, or with an immunocompromised condition or who has undergone radiation therapy to the jaw EX06 Patient suffering from uncontrolled active periodontitis EX07 Patients unable to comply with the requirements of the study - as judged by the Investigator EX08 Participation to another interventional clinical study at the same time EX09 Vulnerable groups (such as known pregnancy or lactation, immuno-compromised patients, patients with legal protection, or patients placed in an institution or custody due to official or court order)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy rate of root canal obturation using clinical and radiological criteria. Objective is one combined endpoint, consisting of: •Functionality: absence of acute inflammatory or pain symptoms (dolor/calor/rubor/tumor/functio laesa) •Radiological assessment of healing: Radiograph of the periapical state will receive a periapical index (PAI) evaluation. Any decrease in the index when compared to Visit 1 will be regarded healing tendency and therefore treatment success (development of bone density and periodont, reduced / stagnating lesion) Primary endpoint needs fulfilment of both criteria. Patients will only be evaluated as responders, if both are fulfilled. Endpoint will serve to confirm non-inferiority of investigational device in comparison with standard of care, as clinical evidence for safety and performance | — |
Secondary
| Measure | Time frame |
|---|---|
| Radiological evaluation of the level of apical obturation and density: - Apical extension within 0-2mm of apex - Absence of gaps | — |
Countries
Austria, Germany
Contacts
Public ContactDina Badry
Endodont GmbH
Outcome results
None listed