Caries, Dental, Remineralization, White Spot Lesion
Conditions
Brief summary
To evaluate the remineralizing capability of biosmart S-PRG barrier coat varnish and its employment in clinical practice
Interventions
DRUGBio-smart Light Cured Protective Shield with bioactive S-PRG (Surface Pre- Reacted Glass ionomer) filler technology (PRG Barrier Coat) by (By SHOFU Inc., Japan).
Surface reaction-type pre-released glass ionomer (S-PRG) fillers containing dental materials are now commercially available. It was shown that PRG filler is an active ingredient with the ability to release and recharge fluoride ions. In addition, S-PRG fillers release five other active ions, Sr2þ, SiO3 2, Naþ, BO3 3, and Al3þ. S-PRG filler has a modulation effect on acidic conditions, causing the surrounding environment to become weakly alkaline upon contact with water or acidic solutions. This effect was thought to be brought by Sr, B, Na, and F ions released from S-PRG filler. A fluoride-releasing coating material containing S-PRG filler (PRG BarrierCoat®, SHOFU, Japan) was manufactured as a coating material to suppress dentin hypersensitivity and prevent caries on smooth surface areas.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* • Age range between 18 and 40 years. * Patients with no systemic diseases, syndromic abnormalities, or proven/suspected milk protein allergy and/or sensitivity * Patients with fair oral hygiene (mild to moderate plaque accumulation). * Patients with non-cavitated initial carious lesions grade 0 or 1 caries in accordance with The Nyvad caries diagnostic criteria. * The patient did not receive any remineralizing agent other than the regular toothpaste during the past three months.
Exclusion criteria
* • Severe or active periodontal disease. * Patients had received therapeutic irradiation to the head and neck region. * Patients had participated in a clinical trial within 6 months before commencement of this trial. * Patients unable to return for recall appointments * Presence of abnormal oral, medical, or mental condition. * Presence of dentin caries or enamel hypoplasia on maxillary anterior teeth. * Patients with glass ionomer restorations because the glass ionomer restoration release fluoride in the oral cavity, potentially impacting the results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Remineralization efficacy. | Baseline, 1 month, 3 months | Determination of lesion level by DIAGNOdent which provides a laser fluorescence feedback to give a numerical readout reflecting the amount of demineralization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Caries lesion activity assessment | Baseline, 1 month, 3 months | Visual- tactile. The Nyvad criteria is a visual-tactile caries classification system designed to detect the activity and severity of caries lesions, the diagnostic criteria reflect the entire continuum of caries, ranging from clinically sound surfaces to non-cavitated and microcavitated caries lesions in enamel to frank cavitation into the dentine |
Outcome results
None listed