Using a new dental treatment for cavities in adults
Dentin Caries and Polymer-induced Liquid Precursor System (PILP): Adult Safety Study
NA · University of California, San Francisco · NCT06727110
This study is testing a new dental treatment for cavities in adults to see if it can safely help fix teeth without causing any harm.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | University of California, San Francisco (other) |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT06727110 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety of Polymer-Induced Liquid Precursor (PILP) in treating dentin caries in adults. Participants will receive either PILP or a placebo before having a filling placed in a carious tooth. The study involves multiple follow-up visits to monitor for any adverse effects over a six-month period. The primary focus is to determine if PILP can be safely used without causing harm to the tooth or the patient.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 64 with at least one posterior tooth diagnosed with dentin caries that requires restoration.
Not a fit: Patients with known allergies to components of the study device or those with irreversible pulpitis will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a safer and more effective option for managing dental caries in adults.
How similar studies have performed: While this approach is novel, similar studies evaluating new dental materials have shown promise in improving treatment outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
San Francisco, California
- University of California San Francisco, School of Dentistry — San Francisco, California, United States (RECRUITING)
Study contacts
- Principal investigator: Stefan Habelitz, PhD — Stefan Habelitz, PhD
- Study coordinator: Jean Star, DDS, MPH
- Email: jean.star@ucsf.edu
- Phone: 415-514-9768
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dental Caries