Dentin Caries and Polymer-induced Liquid Precursor System (PILP): Adult Safety Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Pulpal response
Study Overview
Brief 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 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •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
Arms & Interventions
PILP Conditioner and Cement
PILP conditioner and cement placement prior to tooth restoration.
Intervention: PILP Cement (Device)
PILP Conditioner
PILP conditioner application prior to tooth restoration.
Intervention: PILP Conditioner (Device)
No intervention
Placement of traditional dental restoration without additional intervention.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Dental pain/sensitivity(Tooth pain will be assessed at 48 hours, 1 month, 3 month and 6 months after placement of the restoration.)
- Gingival Inflammation(Gingival inflammation will be assed by intra-oral clinical exam at 3 and 6 months post restoration placement.)
- Periapical status(A dental radiograph of the tooth will be take at 3 and 6 months post restoration placement.)