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Prospective randomized controlled clinical study for the investigation of self-limiting caries excavation by means of polymer core drill on the postoperative rate of pulpal complications

Prospective randomized controlled clinical study for the investigation of self-limiting caries excavation by means of polymer core drill on the postoperative rate of pulpal complications

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00036852
Enrollment
110
Registered
2025-05-12
Start date
2025-05-12
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K04.0

Interventions

Group 1: Control group: Caries excavation with conventional rose bur with arbitrary caries excavation (selective caries excavation). Group 2: Study group: Caries excavation with the already approved p

Sponsors

Poliklinik für Zahnerhaltung und Parodontologie, Klinikum der Universität München, LMU München
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adult patients with tooth-related criteria: permanent, vital, non-percussion-sensitive, non-spontaneously painful posterior teeth with radiologically confirmed D4 lesion, written consent for voluntary participation in the study.

Exclusion criteria

Exclusion criteria: Lack of capacity to consent, intolerance to materials used materials used, poor AZ, tooth-related criteria: Tooth mobility > II, avital, sensitive to percussion, subgingival cavities without the possibility of draining before adhesive restoration.

Design outcomes

Primary

MeasureTime frame
Measuring instrument: clinical examination: After 6, 12 and 36 months, the clinical parameters of pain history, sensitivity and percussion findings, as well as the occurrence of postoperative complications, are assessed again as part of a follow-up if there are no complaints. indication, radiological findings, for example to exclude pulpal disease/inflammatory conditions. Furthermore quality of the restoration is assessed using the FDI criteria and the restoration is restoration from two perspectives (occlusal, buccal). Achievement of 36-month follow-up with clinical freedom from symptoms.

Secondary

MeasureTime frame
Secondary endpoints: Pulp opening in the treatment session, and if irreversible pulpitis or pulp necrosis develops in the follow-up Time frame.

Countries

Germany

Contacts

Public ContactKatrin Heck

Poliklinik für Zahnerhaltung und Parodontologie, Klinikum der Universität München, LMU München

katrin.heck@med.uni-muenchen.de+49 89 4400 59303

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026