Polymer Induced Liquid Precursor (PILP) in Adults in With Dentin Caries
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PILP Cement, PILP Conditioner.
- Who it may be relevant to
- Registry conditions: Dental Caries. Basic parameters: 18 years — 64 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Dentin Caries and Polymer-induced Liquid Precursor System (PILP): Adult Safety Study
Overview
The goal of this clinical trial is to learn if polymer-induced liquid precursor (PILP) can be used safely to treat dentin caries (cavities) in adults. The main question it aims to answer is: Is PILP (conditioner or liner) safe in adult teeth with dental caries? Researchers will compare PILP to a placebo (a look-alike substance that contains no drug) to see if PILP safely treats cavities in teeth. Participants will: 1) Have PILP or placebo applied to their tooth prior to the placement of a filling in the tooth, 2) Complete two telephone calls within three months of filling placement and 3) Visit the clinic at three months and six months after the placement of the filling.
Detailed description
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.
Interventions
- Device PILP Cement
PILP cement liner. - Device PILP Conditioner
PILP solution.
Primary outcome measures
- Pulpal response [Time frame: Tooth vitality testing will occur approximatley 3 months and 6 months after placement of the restoration.]
Secondary outcome measures (3)
- Dental pain/sensitivity [Time frame: Tooth pain will be assessed at 48 hours, 1 month, 3 month and 6 months after placement of the restoration.]
- Gingival Inflammation [Time frame: Gingival inflammation will be assed by intra-oral clinical exam at 3 and 6 months post restoration placement.]
- Periapical status [Time frame: A dental radiograph of the tooth will be take at 3 and 6 months post restoration placement.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of California San Francisco, School of Dentistry — San Francisco
Publications
- Bacino M, Girn V, Nurrohman H, Saeki K, Marshall SJ, Gower L, Saeed E, Stewart R, Le T, Marshall GW, Habelitz S. Integrating the PILP-mineralization process into a restorative dental treatment. Dent Mater. 2019 Jan;35(1):53-63. doi: 10.1016/j.dental.2018.11.030. Epub 2018 Dec 10. PMID 30545611
Identifiers
NCT: NCT06727110 · 24-40868