30 Participants Needed

PILP Treatment for Tooth Decay

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Overseen ByStefan Habelitz, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of California, San Francisco
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

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.12345

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.678910

Who Is on the Research Team?

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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?
3Treatment groups
Experimental Treatment
Active Control
Group I: PILP Conditioner and CementExperimental Treatment1 Intervention
PILP conditioner and cement placement prior to tooth restoration.
Group II: PILP ConditionerExperimental Treatment1 Intervention
PILP conditioner application prior to tooth restoration.
Group III: No interventionActive Control1 Intervention
Placement of traditional dental restoration without additional intervention.

Find a Clinic Near You

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

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.
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.
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.
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]

Citations

Shear Bond Strength Evaluation of Resin Composite Bonded to GIC Using Different Adhesives. [2020]
Clinical evaluation of three caries removal approaches in primary teeth: a randomised controlled trial. [2022]
Comparative Evaluation of Resin Infiltration and Remineralisation of Noncavitated Smooth Surface Caries Lesions: 6-month Results. [2021]
Antibacterial and mechanical properties of propolis added to glass ionomer cement. [2021]
Clinical and radiographic evaluation of Portland cement added to radiopacifying agents in primary molar pulpotomies. [2022]
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]
Assessment of push-out bond strength of post-surface pretreatment before salinization using hydrogen peroxide, aluminum trioxide, and natural photosensitizers to radicular dentin. [2022]
Adhesion of glass-ionomer cement sealers to bovine dentin conditioned with intracanal medications. [2019]
The microtensile bond strength of Fuji IX glass ionomer cement to antibacterial conditioned dentin. [2019]
Repair of glass ionomer cements--methods for conditioning the surface of the cement to achieve bonding. [2019]
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