Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05509920
Other study ID # Giomer based barrier coat
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 2022
Est. completion date December 2023

Study information

Verified date August 2022
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 58
Est. completion date December 2023
Est. primary completion date November 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
S-PRG barrier coat
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of caries arrest Evaluation 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). one year
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04822246 - Root Caries Excavation With Air Water/Powder Prophylaxis Device for ART Restorations N/A
Suspended NCT04432415 - Comparison of Silver Diamine Fluoride and Sodium Fluoride Varnish to Prevent and Arrest Root Caries in Older Adults N/A
Completed NCT02647203 - Non-invasive Treatment of Root Caries in Older Adults Phase 1/Phase 2
Active, not recruiting NCT03722758 - 36-Month Clinical Performance of Different Restorative Materials in the Treatment of Root Caries Lesions N/A
Completed NCT04370080 - Silver Diamine Fluoride Treatment of Active Root Caries Lesions in Older Adults: A Case Series N/A
Recruiting NCT06131957 - Root Caries Prevention Using Fluoride Varnish Fortified With SBGC N/A
Not yet recruiting NCT05765058 - The Efficacy of Tooth Mouse, SFD and NaF in Caries Activity in Root Caries. A Randomized Clinical Trial N/A
Active, not recruiting NCT03654820 - Effectiveness on SDF Solution and PVP-I Combined NaF Varnish in Preventing Root Caries in Elders N/A