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

NCT ID: NCT06727110

Last Updated: 2025-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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PILP Conditioner and Cement

PILP conditioner and cement placement prior to tooth restoration.

Group Type EXPERIMENTAL

PILP Cement

Intervention Type DEVICE

PILP cement liner.

PILP Conditioner

PILP conditioner application prior to tooth restoration.

Group Type EXPERIMENTAL

PILP Conditioner

Intervention Type DEVICE

PILP solution.

No intervention

Placement of traditional dental restoration without additional intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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PILP Cement

PILP cement liner.

Intervention Type DEVICE

PILP Conditioner

PILP solution.

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stefan Habelitz, PhD

Role: PRINCIPAL_INVESTIGATOR

Stefan Habelitz, PhD

Locations

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University of California San Francisco, School of Dentistry

San Francisco, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jean Star, DDS, MPH

Role: CONTACT

415-514-9768

Jessica Snider, MBA

Role: CONTACT

4155146994

Facility Contacts

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Jean Star, DDS, MPH

Role: primary

415-514-9768

Jessica Snider, MBA

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 30545611 (View on PubMed)

Other Identifiers

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24-40868

Identifier Type: -

Identifier Source: org_study_id

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