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

NCT05306691 | Unknown Early Phase 1 DMC FDA Drug

• 1 other identifier: Giomer Bioative varnish
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Caries, Dental; Remineralization; White Spot Lesion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Caries lesion activity assessment

  Baseline, 1 month, 3 months

Study Arms (2)

Bio-smart Light Cured Protective Shield with bioactive S-PRG filler technology (PRG Barrier Coat)

EXPERIMENTAL

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

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).

5% NaF varnish (Proflourid Varnish VOCO America Inc.).

ACTIVE COMPARATOR

The gold standard remineralizing agent recommended by the guidelines

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).

Interventions

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). DRUG

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.

5% NaF varnish (Proflourid Varnish VOCO America Inc.).; Bio-smart Light Cured Protective Shield with bioactive S-PRG filler technology (PRG Barrier Coat)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Dental Caries

Interventions

PRG Barrier Coat

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master degree student, Conservative Dentistry Department Principal investigator

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: April 1, 2022
• Study Start: May 15, 2022
• Primary Completion: August 15, 2022
• Study Completion: September 15, 2022
• Last Updated: April 1, 2022

Record last verified: 2022-03