NCT06727110

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Feb 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress68%
Feb 2025Dec 2026

First Submitted

Initial submission to the registry

December 6, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 10, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

1.6 years

First QC Date

December 6, 2024

Last Update Submit

March 4, 2026

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Dental pain/sensitivity

    Tooth pain will be assessed at 48 hours, 1 month, 3 month and 6 months after placement of the restoration.

  • Gingival Inflammation

    Gingival inflammation will be assed by intra-oral clinical exam at 3 and 6 months post restoration placement.

  • Periapical status

    A dental radiograph of the tooth will be take at 3 and 6 months post restoration placement.

Study Arms (3)

PILP Conditioner and Cement

EXPERIMENTAL

PILP conditioner and cement placement prior to tooth restoration.

Device: PILP Cement

PILP Conditioner

EXPERIMENTAL

PILP conditioner application prior to tooth restoration.

Device: PILP Conditioner

No intervention

NO INTERVENTION

Placement of traditional dental restoration without additional intervention.

Interventions

PILP CementDEVICE

PILP cement liner.

PILP Conditioner and Cement
PILP ConditionerDEVICE

PILP solution.

PILP Conditioner

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Francisco, School of Dentistry

San Francisco, California, 94143, United States

RECRUITING

Related Publications (1)

  • 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: 30545611BACKGROUND

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Stefan Habelitz, PhD

    Stefan Habelitz, PhD

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean Star, DDS, MPH

CONTACT

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

Jessica Snider, MBA

CONTACT

4155146994jessica.snider@ucsf.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2024

First Posted

December 10, 2024

Study Start

February 1, 2025

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 6, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)