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

Dentin Caries and Polymer-induced Liquid Precursor System (PILP): Adult Safety Study

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.

Study Overview

• Status: Recruiting
• Conditions: Dental Caries
• Intervention / Treatment: Device: PILP Cement; Device: PILP Conditioner

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean Star, DDS, MPH; Phone Number: 415-514-9768; Email: jean.star@ucsf.edu
• Study Contact Backup: Name: Jessica Snider, MBA; Phone Number: 4155146994; Email: jessica.snider@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California San Francisco, School of Dentistry
      • Contact: Jean Star, DDS, MPH; Phone Number: 415-514-9768; Email: jean.star@ucsf.edu
      • Contact: Jessica Snider, MBA; Email: jessica.snider@ucsf.edu
      • Principal Investigator: Jean Star, DDS, MPH
      • Sub-Investigator: Ram Vaderhobli, DDS, MS
      • Sub-Investigator: Stefan Habelitz, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PILP Conditioner; PILP conditioner application prior to tooth restoration.	Device: PILP Conditioner; PILP solution.
No Intervention: No intervention; Placement of traditional dental restoration without additional intervention.
Experimental: PILP Conditioner and Cement; PILP conditioner and cement placement prior to tooth restoration.	Device: PILP Cement; PILP cement liner.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulpal response	Tooth vitality (pulpal response) after intervention.	Tooth vitality testing will occur approximatley 3 months and 6 months after placement of the restoration.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dental pain/sensitivity	The dental pain/sensitivity assessment will include Visual Analog Scale (VAS) for dental pain.	Tooth pain will be assessed at 48 hours, 1 month, 3 month and 6 months after placement of the restoration.
Gingival Inflammation	Intra-Oral Assessment and Photographs will assess gingival inflammation (Löe-Silness gingival index).	Gingival inflammation will be assed by intra-oral clinical exam at 3 and 6 months post restoration placement.
Periapical status	Dental radiographs will assess periapical status (periapical index)	A dental radiograph of the tooth will be take at 3 and 6 months post restoration placement.

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Stefan Habelitz, PhD, Stefan Habelitz, PhD

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 6, 2024
• First Submitted That Met QC Criteria: December 6, 2024
• First Posted (Actual): December 10, 2024

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization; Dental Caries
• Other Study ID Numbers: 24-40868

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes