Polymer Induced Liquid Precursor (PILP) in Adults in With Dentin Caries
NCT ID: NCT06727110
Last Updated: 2025-02-07
Study Results
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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RECRUITING
NA
30 participants
INTERVENTIONAL
2025-02-01
2025-12-31
Brief Summary
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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.
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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PILP Conditioner and Cement
PILP conditioner and cement placement prior to tooth restoration.
PILP Cement
PILP cement liner.
PILP Conditioner
PILP conditioner application prior to tooth restoration.
PILP Conditioner
PILP solution.
No intervention
Placement of traditional dental restoration without additional intervention.
No interventions assigned to this group
Interventions
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PILP Cement
PILP cement liner.
PILP Conditioner
PILP solution.
Eligibility Criteria
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Inclusion Criteria
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)
18 Years
64 Years
ALL
No
Sponsors
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University of California, San Francisco
OTHER
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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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.
Other Identifiers
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24-40868
Identifier Type: -
Identifier Source: org_study_id
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