Summary

Eligibility
for people ages 18-64 (full criteria)
Location
at San Francisco, California
Dates
study started
completion around
Principal Investigator
by Jean Star, DDS, MPH

Description

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 questions 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.

Official Title

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

Details

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.

Keywords

Dental Caries, PILP Cement, PILP Conditioner

Eligibility

You can join if…

Open to people ages 18-64

  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)

You CAN'T join if...

Known allergic reactions to components of the study device

Location

  • UCSF, School of Dentistry
    San Francisco California 94143 United States

Lead Scientist at UCSF

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT06727110
Study Type
Interventional
Participants
Expecting 30 study participants
Last Updated