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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PILP Conditioner and Cement | Experimental | PILP conditioner and cement placement prior to tooth restoration. |
|
| PILP Conditioner | Experimental | PILP conditioner application prior to tooth restoration. |
|
| No intervention | No Intervention | Placement of traditional dental restoration without additional intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PILP Cement | Device | PILP cement liner. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pulpal response | Tooth vitality (pulpal response) after intervention. | Tooth vitality testing will occur approximatley 3 months and 6 months after placement of the restoration. |
| Measure | Description | Time Frame |
|---|---|---|
| Dental pain/sensitivity | The dental pain/sensitivity assessment will include Visual Analog Scale (VAS) for dental pain. | Tooth pain will be assessed at 48 hours, 1 month, 3 month and 6 months after placement of the restoration. |
| Gingival Inflammation |
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Inclusion Criteria:
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
Exclusion Criteria: Known allergic reactions to components of the study device
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean Star, DDS, MPH | Contact | 415-514-9768 | jean.star@ucsf.edu | |
| Jessica Snider, MBA | Contact | 4155146994 | jessica.snider@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Stefan Habelitz, PhD | Stefan Habelitz, PhD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco, School of Dentistry | Recruiting | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30545611 | Background | 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. |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| PILP Conditioner |
| Device |
PILP solution. |
|
Intra-Oral Assessment and Photographs will assess gingival inflammation (Löe-Silness gingival index).
| Gingival inflammation will be assed by intra-oral clinical exam at 3 and 6 months post restoration placement. |
| Periapical status | Dental radiographs will assess periapical status (periapical index) | A dental radiograph of the tooth will be take at 3 and 6 months post restoration placement. |