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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the PILP Treatment for Tooth Decay?

Research on glass ionomer cement (GIC), a component similar to PILP Cement, shows it is effective in dental restorations, as it bonds well with other materials and has antibacterial properties when combined with substances like propolis. ^{1 2 3 4 5}

How does the PILP treatment for tooth decay differ from other treatments?

The PILP treatment for tooth decay is unique because it potentially uses a novel approach involving the infiltration of a polymer-induced liquid precursor to remineralize tooth enamel, which is different from traditional methods that often involve drilling and filling cavities. This method aims to restore the natural structure of the tooth without invasive procedures. ^{6 7 8 9 10}

Research Team

Stefan Habelitz, PhD

Principal Investigator

Stefan Habelitz, PhD

Eligibility Criteria

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

I am between 18 and 64 years old.

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

Exclusion Criteria

Known allergic reactions to components of the study device

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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 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]

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 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]

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]

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]

References

1. India pubmed.ncbi.nlm.nih.gov

Shear Bond Strength Evaluation of Resin Composite Bonded to GIC Using Different Adhesives. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Clinical evaluation of three caries removal approaches in primary teeth: a randomised controlled trial. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Comparative Evaluation of Resin Infiltration and Remineralisation of Noncavitated Smooth Surface Caries Lesions: 6-month Results. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Antibacterial and mechanical properties of propolis added to glass ionomer cement. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Clinical and radiographic evaluation of Portland cement added to radiopacifying agents in primary molar pulpotomies. [2022]

6. Netherlands 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. [2022]

7. Netherlands 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Adhesion of glass-ionomer cement sealers to bovine dentin conditioned with intracanal medications. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

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

10. England pubmed.ncbi.nlm.nih.gov

Repair of glass ionomer cements--methods for conditioning the surface of the cement to achieve bonding. [2019]