Remineralizing Efficacy of Giomer Varnish vs. Fluoride Varnish in Management of White Spot Lesions in Adult Patients

White Spot Lesion Clinical Trial

Official title:

Comparative Remineralizing Efficacy of Giomer Bioactive Barrier Varnish vs. Fluoride Varnish in Management of White Spot Lesions in Adult Patients: Randomized Controlled Tria

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05306691
• Other study ID #: Giomer Bioative varnish
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: May 15, 2022
• Est. completion date: September 15, 2022

Study information

• Verified date: March 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the remineralizing capability of biosmart S-PRG barrier coat varnish and its employment in clinical practice

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 26
• Est. completion date: September 15, 2022
• Est. primary completion date: August 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Caries, Dental
• Dental Caries
• Remineralization
• White Spot Lesion

Intervention

Drug:
• Bio-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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Remineralization efficacy.	Determination of lesion level by DIAGNOdent which provides a laser fluorescence feedback to give a numerical readout reflecting the amount of demineralization	Baseline, 1 month, 3 months
Secondary	Change in Caries lesion activity assessment	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	Baseline, 1 month, 3 months