Polymer Induced Liquid Precursor (PILP) in Adults in With Dentin Caries

The proposed study is a first-in-human safety evaluation of Polymer-Induced Liquid Precursor (PILP)-releasing dental materials for the treatment of deep carious lesions in adult posterior teeth.

The study will enroll adult patients diagnosed with carious lesions involving the dentin. Participants will be randomly assigned to one of three intervention groups. The primary objective is to assess the safety of PILP application, with a hypothesis that PILP can be safely used without causing adverse events to the tooth or patient.

Participants will undergo a series of visits starting with a comprehensive screening and consent process, followed by the assigned dental procedure involving caries removal and restoration. Follow-up evaluations will occur at 48 hours, 1 month, 3 months, and 6 months post-procedure to monitor for any symptoms or adverse outcomes.

Inclusion criteria

• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged 18 to sixty-four
• In good general health as evidenced by medical history (ASA 1 or 2)
• With at least one posterior tooth with caries to dentin

• The tooth must have a pulpal diagnosis of pulpal health (no irreversible pulpitis or periapical radiolucency)
• The tooth should have no existing restorations
• The caries should be a Class I or class V single surface lesion
• The tooth should be planned for restoration with intra-coronal restoration (composite or RMGI restoration)
• The tooth should be deemed as needing a restoration based on ICDAS (International Caries Detection and Assessment System)

Exclusion criteria

Known allergic reactions to components of the study device