Recruiting

PILP

Sponsor:

UCLA

Code:

NCT06727110

Conditions

Dental Caries

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

PILP Cement

PILP Conditioner

Study Details

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.

Conditions

Dental Caries

Study ID

NCT06727110

Start date

Feb 1, 2025

Status verified date

Mar, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PILP Conditioner and Cement

PILP conditioner and cement placement prior to tooth restoration.

experimental: PILP Conditioner

PILP conditioner application prior to tooth restoration.

no intervention: No intervention

Placement of traditional dental restoration without additional intervention.

Interventions

PILP Cement

PILP cement liner.

PILP Conditioner

PILP solution.

Primary outcome measure

  • Pulpal response [ Time Frame: Tooth vitality testing will occur approximatley 3 months and 6 months after placement of the restoration. ]

Central Contacts and Locations

Central contacts

Jean Star, DDS, MPH

415-514-9768jean.star@ucsf.edu

Jessica Snider, MBA

4155146994jessica.snider@ucsf.edu

Locations

University of California San Francisco, School of Dentistry

Recruiting

San Francisco, California, United States, 94143

Contacts

Jean Star, DDS, MPH

415-514-9768jean.star@ucsf.edu

Jessica Snider, MBA

jessica.snider@ucsf.edu

Principal Investigator:

Jean Star, DDS, MPH

More Information

Sponsor

University of California, San Francisco

Last update posted

Mar 6, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-03-06.