PILP Treatment for Tooth Decay

Overseen By Stefan Habelitz, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Allergic to study device components

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 1 day

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new treatment, polymer-induced liquid precursor (PILP), is safe for treating cavities in adult teeth. Researchers will apply PILP to teeth before placing a filling and compare its safety to a placebo (a substance with no active drug). The trial seeks adults with at least one back tooth cavity needing filling and no existing restorations. Participants will attend clinic visits and phone calls over six months to monitor the treatment's effectiveness and safety. As an unphased trial, this study offers participants the chance to contribute to pioneering research that could enhance dental care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on dental treatment, so it's unlikely that your regular medications would be affected, but you should confirm with the study team.

What prior data suggests that PILP is safe for treating dental caries?

Research has shown that Polymer-Induced Liquid Precursor (PILP) treatments could benefit dental care, particularly in repairing cavities. PILP has been tested for its ability to rebuild tooth material in both artificial and real tooth damage. Although specific safety information from these studies is limited, PILP treatments are intended for use by dentists, indicating they are applied safely and in a controlled manner.

For the PILP conditioner and cement, a safety sheet notes potential eye irritation, which serves as a general handling warning rather than a concern for dental use. When applied correctly by a dentist, the treatment should be safe. However, since the studies do not provide detailed safety results, participants should discuss any concerns with the clinical team. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about PILP Cement and Conditioner because they offer a novel approach to treating tooth decay. Unlike traditional dental restorations that merely fill cavities, PILP treatments aim to enhance the natural remineralization process of teeth, potentially leading to stronger and longer-lasting repairs. PILP Conditioner prepares the tooth surface, allowing the cement to integrate more effectively, which could improve the durability and adhesion of the restoration. This innovative method could mean fewer repeat visits and longer-lasting results for patients.

What evidence suggests that PILP could be an effective treatment for cavities?

Research has shown that PILP (polymer-induced liquid precursor) could help treat cavities by rebuilding dentin, the layer beneath tooth enamel. Studies have found that PILP can repair both man-made and natural dentin damage. Early results suggest that PILP treatments are safe and effective, with pulp survival rates between 99% and 100%. In this trial, participants may receive either the PILP Conditioner alone or a combination of PILP Conditioner and Cement. PILP might be a good option because it supports the tooth's natural healing, potentially extending the lifespan of fillings. ^{1 2 3 4 6}

Who Is on the Research Team?

Stefan Habelitz, PhD

Principal Investigator

Stefan Habelitz, PhD

Are You a Good Fit for This Trial?

This trial is for adults with dentin caries (cavities) who are seeking treatment. Participants must be willing to have PILP or a placebo applied to their tooth before getting a filling, and agree to follow-up calls and clinic visits at three and six months after the procedure.

Inclusion Criteria

In good general health as evidenced by medical history (ASA 1 or 2)

Stated willingness to comply with all study procedures and availability for the duration of the study

I have a healthy back tooth with a cavity needing a filling.

Exclusion Criteria

Known allergic reactions to components of the study device

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive PILP or placebo applied to their tooth prior to the placement of a filling

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of tooth vitality, gingival inflammation, and dental pain/sensitivity

6 months

2 visits (in-person), 2 telephone calls

What Are the Treatments Tested in This Trial?

Interventions

• PILP Cement
• PILP Conditioner

Trial Overview The study tests Polymer Induced Liquid Precursor (PILP) treatments—either as a cement or conditioner—to see if they're safe alternatives to traditional fillings for cavities in adult teeth. It compares these new treatments against a placebo during dental procedures.

How Is the Trial Designed?

Group I: PILP Conditioner and Cement Experimental Treatment 1 Intervention

PILP conditioner and cement placement prior to tooth restoration.

Group II: PILP Conditioner Experimental Treatment 1 Intervention

PILP conditioner application prior to tooth restoration.

Group III: No intervention Active Control 1 Intervention

Placement of traditional dental restoration without additional intervention.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Published Research Related to This Trial

The study found that using Rely X ARC resin cement with curcumin photosensitizer for disinfecting radicular dentin resulted in the highest tensile bond strength (TBS) of 289.25 N, indicating effective bonding for fiber posts.

Both methylene blue and curcumin photosensitizers showed similar efficacy in maintaining bond strength, while Rely X ARC consistently outperformed glass ionomer cement (GIC) in terms of TBS, suggesting it is a superior choice for post-dentine-cement bonding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radicular canal disinfection by photosensitizers activated by photodynamic therapy and Er, Cr: YSGG laser bonded to glass fiber post using different cement types. An Invitro study. Qamar, Z., Niazi, FH., Alshalan, AM., et al.[2022]

Using a self-etch primer on unset glass ionomer cement (GIC) resulted in significantly higher bond strength when bonding composite materials compared to using a total-etch adhesive or a self-etch primer on set GIC, as demonstrated in a study involving 30 teeth.

The study found that the bonding effectiveness varied depending on the timing of the adhesive application, with the best results achieved when the self-etch primer was applied before the GIC had fully set.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shear Bond Strength Evaluation of Resin Composite Bonded to GIC Using Different Adhesives. Gupta, R., Mahajan, S.[2020]

In a study involving 30 primary mandibular molars from children aged 5 to 9 years, the use of Portland cement (PC) with radiopacifying agents in pulpotomies resulted in a 100% success rate for both clinical and radiographic outcomes over a 24-month follow-up period.

There were no statistically significant differences in outcomes between the different groups treated with PC alone or with iodoform or zirconium oxide, indicating that PC is a reliable material for primary molar pulpotomies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and radiographic evaluation of Portland cement added to radiopacifying agents in primary molar pulpotomies. Lourenço Neto, N., Marques, NC., Fernandes, AP., et al.[2022]

The study found that different endodontic intracanal medications, such as Ca(OH)2 and chlorhexidine, can significantly affect the adhesion of glass-ionomer cement (GIC) sealers to dentin, indicating that the choice of medication can impact treatment outcomes.

Among the GIC sealers tested, ZUT showed consistent bond strength regardless of the conditioning medium, while Ketac-Endo had lower adhesion when conditioned with Ca(OH)2 and formocresol, suggesting that ZUT may be a more reliable option for root canal sealing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adhesion of glass-ionomer cement sealers to bovine dentin conditioned with intracanal medications. Chung, HA., Titley, K., Torneck, CD., et al.[2019]

In a study involving 276 children aged 6-11, different caries removal techniques before glass ionomer cement (GIC) restoration showed similar clinical performance, with cumulative survival rates of GIC restorations at 83% for partial soft caries removal and 89% for conventional methods after 12 months.

All techniques resulted in high pulp survival rates (99% to 100%), indicating that partial soft caries removal is a safe and effective method comparable to traditional approaches for restoring primary molars.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of three caries removal approaches in primary teeth: a randomised controlled trial. Phonghanyudh, A., Phantumvanit, P., Songpaisan, Y., et al.[2022]

The study found that using aluminum oxide (Al2O3) combined with silane significantly improved the bond strength of glass fiber posts to resin cement, achieving the highest push-out bond strength in the coronal section (8.23±0.14 MPa).

Hydrogen peroxide (H2O2) combined with silane also showed comparable bond strength results to aluminum oxide across all sections, indicating that these surface pretreatment methods enhance the effectiveness of the bond, while the use of photosensitizers like riboflavin and curcumin did not yield better results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of push-out bond strength of post-surface pretreatment before salinization using hydrogen peroxide, aluminum trioxide, and natural photosensitizers to radicular dentin. Qamar, Z., Abdul, NS., Ali, S., et al.[2022]

The study evaluated the repair strength of two types of glass ionomer cements (Ketac Fil and ChemFil II Caps) using different surface conditioning methods, finding that repaired specimens had lower flexural strength compared to control specimens.

Using phosphoric acid for surface conditioning resulted in repaired specimens achieving about 80% of the strength of the controls, while polyacrylic acid produced the weakest repair, indicating that the choice of conditioning agent significantly impacts repair efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repair of glass ionomer cements--methods for conditioning the surface of the cement to achieve bonding. Jamaluddin, A., Pearson, GJ.[2019]

The resin infiltration technique (Icon) showed the most significant reduction in white spot lesions (WSLs) after 6 months, outperforming both self-assembling peptide (Curodont Repair) and fluoride varnish (Duraphat) treatments, indicating its efficacy in managing non-cavitated caries lesions.

All treatment groups, including a control group with regular brushing, demonstrated a decrease in WSLs over 6 months, suggesting that non-operative approaches can effectively manage these lesions, especially in individuals at moderate to high risk for caries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Evaluation of Resin Infiltration and Remineralisation of Noncavitated Smooth Surface Caries Lesions: 6-month Results. Gözetici, B., Öztürk-Bozkurt, F., Toz-Akalın, T.[2021]

Adding 25% and 50% ethanolic extracts of propolis (EEP) to glass ionomer cement (GIC) significantly inhibited the growth of Streptococcus mutans, a common bacteria associated with dental issues.

The mechanical properties of GIC, measured by shear-peel band strength, remained unchanged regardless of the EEP concentration, indicating that the antibacterial enhancement does not compromise the cement's structural integrity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antibacterial and mechanical properties of propolis added to glass ionomer cement. Hatunoğlu, E., Oztürk, F., Bilenler, T., et al.[2021]

The study found that adding antibacterial agents like benzalkonium chloride (BC) to a dentin conditioner can negatively impact the bond strength of glass ionomer cement (GIC) to dentin, particularly at a 5% concentration.

Only the 5% BC-dentin conditioner, when left in situ, showed a significant reduction in bond strength compared to other tested conditions, indicating that while antibacterial agents can be beneficial, their concentration and application method are crucial for maintaining bond integrity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The microtensile bond strength of Fuji IX glass ionomer cement to antibacterial conditioned dentin. Botelho, MG.[2019]

Citations

1. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06727110

Polymer Induced Liquid Precursor (PILP) in Adults in With ... The goal of this clinical trial is to learn if polymer-induced liquid precursor (PILP) can be used safely to treat dentin caries (cavities) ...

2. withpower.com withpower.com/trial/phase-dental-caries-2025-31d6e

PILP Treatment for Tooth Decay All techniques resulted in high pulp survival rates (99% to 100%), indicating that partial soft caries removal is a safe and effective method comparable to ...

3. trial.medpath.com trial.medpath.com/clinical-trial/47dbb1662dab085e/nct06727110-dentin-caries-pilp-adult-safety

Polymer Induced Liquid Precursor (PILP) in Adults ... - MedPath 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.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9356590/

PILP remineralization of artificial and natural dentin carious ... The study evaluates the efficacy to remineralize artificial and natural dentin lesions through restorative dental procedures that include the Polymer-Induced ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9637592/

Clinical effectiveness of restorative materials for the ... To systematically search the available evidence and evaluate the clinical effectiveness of restorative materials for restoration of carious primary teeth.

6. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/tooth-decay

UCSF Tooth Decay Clinical Trials — San Francisco Bay Area 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.