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

Sponsor

Cairo University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05306691

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Caries, Dental Remineralization White Spot Lesion	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).	Early Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

May 15, 2022

Anticipated Primary Completion Date :

Aug 15, 2022

Anticipated Study Completion Date :

Sep 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bio-smart Light Cured Protective Shield with bioactive S-PRG filler technology (PRG Barrier Coat) 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). 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.
Active Comparator: 5% NaF varnish (Proflourid Varnish VOCO America Inc.). 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). 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.

Arm

Intervention/Treatment

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

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).

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

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).

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hisham Amr Mohamed Kotb, Master degree student, Conservative Dentistry Department Principal investigator, Cairo University

ClinicalTrials.gov Identifier:

NCT05306691

Other Study ID Numbers:

Giomer Bioative varnish

First Posted:

Apr 1, 2022

Last Update Posted:

Apr 1, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Dental Caries

Study Results

No Results Posted as of Apr 1, 2022