Skip to content

Assessment of Arresting Root Surface Caries After the Application of PRG Bioactive Varnish

Assessment of Arresting Root Surface Caries After the Application of PRG Bioactive Varnish Versus SDF Varnish Over a Period of 1 Year Follow up

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05509920
Enrollment
58
Registered
2022-08-22
Start date
2022-10-31
Completion date
2023-12-31
Last updated
2022-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Root Caries

Brief summary

Guidelines proved that arresting and remineralization of the root surface caries is better than weakening the tooth structure and restoring it. Manufacturer claims that PRG Barrier Coat effectively treats dental hypersensitivity by providing immediate and long-lasting relief. Also has the effect of eliminating the activity and sur-vival of pathogenic bacteria and hardening the dentin tissue of the affected areas.

Detailed description

A light-cured varnish with extended protection time of up to 6 months, PRG barrier coat incorporates proprietary GIOMER tech-nology, Surface Pre-Reacted Glass for high fluoride release and re-charge, continuous release of fluoride, strontium, boron, sodium, aluminum, and zinc, acid neutralization and anti-plaque benefits with excellent self-adhesive abilities. The new material could be an alter-native to SDF varnish in root caries arrest to overcome its unfavor-able color and taste. Products containing S-PRG fillers have been developed in a wide variety of areas such as tooth surface coating materials, seal-ants, restoration resins and dentifrices. The use of these materials is also expected to have the effect of improving the properties of enamel. In this seminar, we will introduce a new caries prevention using S-PRG filler The eluted ions from the S-PRG filler containing materials exhibit various functions, such as prohibition of biofilm attachment, anti-demineralization, remineralization, modification of apatite crystal, and acid-buffering effect. Each ion was confirmed its function. Par-ticularly, Strontium, Borate and Fluoride ions were involved during calcium phosphate nucleation to form modified nano-hydroxyapatite. The acid buffering effect was shown with the borate ion. As the results of those effects of ions, the various materials with S-PRG technology were proven to con-tribute to increase the acid resistance and the caries prevention.

Interventions

S-PRG filler was the best composition of compressive strength and F- and B release acid buffering capacity. It was found to be the most promising for use as a novel cement.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* Teeth with primary root surface caries (active dentin carious le-sions) * Teeth with gum recession. * Teeth are vital according to pulp-sensitivity tests. * Controlled gingival or periodontal conditions.

Exclusion criteria

* Retained deciduous teeth; as the research is targeting only per-manent teeth. * Teeth with previous restorations which may add another varia-ble to the study (type of old restorative material, extent of re-current caries). * Spontaneous pain or prolonged pain after sensitivity tests (cold and electrical tests) indicating irreversible pulpitis. * Negative sensitivity tests, periapical radiolucencies, and sensi-tivity to axial or lateral percussion indicating pulp necrosis. * Teeth presenting external or internal resorption, with adverse pulpal reactions which may affect the outcome of the study.

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of caries arrestone yearEvaluation of caries arrest by visual tactile evaluation. (mean number of arrested carious lesions that become hard, smooth and free from plaque post application of both SDF and S-PRG varnishes).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026