Clinical trial NCT06727110: Polymer Induced Liquid Precursor (PILP) in Adults in With Dentin Caries
Official title: Dentin Caries and Polymer-induced Liquid Precursor System (PILP): Adult Safety Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Caries
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

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

   1. The tooth must have a pulpal diagnosis of pulpal health (no irreversible pulpitis or periapical radiolucency)
   2. The tooth should have no existing restorations
   3. The caries should be a Class I or class V single surface lesion
   4. The tooth should be planned for restoration with intra-coronal restoration (composite or RMGI restoration)
   5. 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

Primary outcomes:
measure: Pulpal response
timeFrame: Tooth vitality testing will occur approximatley 3 months and 6 months after placement of the restoration.
Secondary outcomes:
measure: Dental pain/sensitivity
timeFrame: Tooth pain will be assessed at 48 hours, 1 month, 3 month and 6 months after placement of the restoration.
measure: Gingival Inflammation
timeFrame: Gingival inflammation will be assed by intra-oral clinical exam at 3 and 6 months post restoration placement.
measure: Periapical status
timeFrame: A dental radiograph of the tooth will be take at 3 and 6 months post restoration placement.
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco, School of Dentistry
state: California
Study officials:
affiliation: Stefan Habelitz, PhD
name: Stefan Habelitz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.