Dental CariesNCT06727110
Polymer Induced Liquid Precursor (PILP) in Adults in With Dentin Caries
A study testing PILP Cement and PILP Conditioner in people with Dental Caries, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- PILP Cement and PILP Conditioner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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)
- Exclusion Criteria: Known allergic reactions to components of the study device
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California San Francisco, School of Dentistry
San Francisco, California, 94143
Jean Star, DDS, MPH, 415-514-9768, jean.star@ucsf.edu
Jessica Snider, MBA, jessica.snider@ucsf.edu
About this study
Official title: Dentin Caries and Polymer-induced Liquid Precursor System (PILP): Adult Safety Study
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.
Read the detailed description
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
- Dental Caries
- Being tested
- PILP Cement, PILP Conditioner
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PILP CementDevice
PILP cement liner.
PILP ConditionerDevice
PILP solution.
| Study group | Role | What they receive |
|---|---|---|
| PILP Conditioner and Cement | Experimental | PILP conditioner and cement placement prior to tooth restoration. Receives: Device: PILP Cement |
| PILP Conditioner | Experimental | PILP conditioner application prior to tooth restoration. Receives: Device: PILP Conditioner |
| No intervention | No intervention | Placement of traditional dental restoration without additional intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulpal response
Tooth vitality (pulpal response) after intervention.
Measured: Tooth vitality testing will occur approximatley 3 months and 6 months after placement of the restoration.
Secondary outcomes (3)
Dental pain/sensitivity
The dental pain/sensitivity assessment will include Visual Analog Scale (VAS) for dental pain.
Measured: Tooth pain will be assessed at 48 hours, 1 month, 3 month and 6 months after placement of the restoration.
Gingival Inflammation
Intra-Oral Assessment and Photographs will assess gingival inflammation (Löe-Silness gingival index).
Measured: 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)
Measured: A dental radiograph of the tooth will be take at 3 and 6 months post restoration placement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start1 Feb 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Habelitz, PhD, Principal investigator, Stefan Habelitz, PhD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727110
- Sponsor's protocol ID
- 24-40868
- Status last verified
- Mar 2026
- First submitted
- 6 Dec 2024
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 30545611
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dentin Caries and Polymer-induced Liquid Precursor System (PILP): Adult Safety Study
- ClinicalTrials.gov ID
- NCT06727110
- Acronym / sponsor ID
- 24-40868
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PILP Conditioner and Cement | Experimental | Device: PILP CementPILP conditioner and cement placement prior to tooth restoration. |
| PILP Conditioner | Experimental | Device: PILP ConditionerPILP conditioner application prior to tooth restoration. |
| No intervention | No intervention | –Placement of traditional dental restoration without additional intervention. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PILP CementPILP cement liner. | Device | PILP Conditioner and Cement |
| PILP ConditionerPILP solution. | Device | PILP Conditioner |
Primary outcome
Pulpal response
Time frame: Tooth vitality testing will occur approximatley 3 months and 6 months after placement of the restoration.
Tooth vitality (pulpal response) after intervention.
3 secondary outcomes
Dental pain/sensitivity
Time frame: Tooth pain will be assessed at 48 hours, 1 month, 3 month and 6 months after placement of the restoration.
Gingival Inflammation
Time frame: Gingival inflammation will be assed by intra-oral clinical exam at 3 and 6 months post restoration placement.
Periapical status
Time frame: A dental radiograph of the tooth will be take at 3 and 6 months post restoration placement.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Background: PubMed 30545611Bacino 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.
- Individual participant dataSharing planned: No
Related trials for Dental Caries
Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stefan Habelitz, PhD principal investigator
Stefan Habelitz, PhD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PILP Cement and PILP Conditioner in people with Dental Caries, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean Star, DDS, MPH (415-514-9768, jean.star@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulpal response (time frame: Tooth vitality testing will occur approximatley 3 months and 6 months after placement of the restoration.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06727110, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.