Clinical Evaluation of White Spot Lesions Treated by S-PRG and ICON

Al-Azhar University

Status: Invitation-only

Conditions: White Spot Lesion

Treatments: Other: Two composite resin sealants; Other: Giomer

Study type: Interventional

Funder types: Other

Identifiers

NCT05550116

2286488

Details and patient eligibility

About

Randomized with (1:1) prospective, double-blind, controlled trial. Subjects will be randomized to receive S-PRG and the control group receives ICON.

Full description

Interventions: - All the procedures will be performed by the same clinician. DIAGNOdent will be used to assess the fluorescence loss of WSLs and the adjacent sound enamel. WSLs in permanent teeth will be treated according to the manufacturer's instructions with:

• Group I (Control group): 20 teeth will be treated with ICON.
• Group II ( EXPERIMENTAL) : 20 teeth will be treated with PRG BarrierCoat.

Observation: - The treatment methods will be assessed immediately after the intervention, 3 months,6 months, and one year. The data will be collected for evaluation of the difference in color and fluorescence loss between the treatment groups, by using DIAGNOdent devices, over different time intervals.

Ethical considerations: The research protocol is approved by the ethical committee, Faculty of Dental Medicine, Al-Azhar University and the enrolled patients should sign a written consent form.

Enrollment: 20 estimated patients

Sex: All

Ages: 19 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients within 20-40 years of age.
• Each patient has 4 or more WSLs.
• Mild and moderate WSLs according to Gorelick's scale.
• Good oral hygiene and willing patients who can attend the study visits.
• a Symmetrical number of permanent teeth in each arch (mesial to second molars).

Exclusion criteria

• Active carious lesions.
• Facial surface restorations.
• Intrinsic and extrinsic stains.
• Patients who have a significant medical history or if they smoke.
• Criteria for discontinuation; Mortality and acquiring severe debilitating disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 4 patient groups

Icon resin infiltration material

Active Comparator group

Description:

Smooth surface resin infiltration comprises three steps for resin infiltration; Icon etch, Icon dry, and Icon infiltrant

Treatment:

Other: Giomer

Other: Two composite resin sealants

PRG Barrier Coat

Experimental group

Description:

fluoride-releasing coating material containing surface reaction-type pre-reacted glass-ionomer (S-PRG) fillers

Treatment:

Other: Two composite resin sealants

Permaseal composite resin sealant

Experimental group

Description:

Permaseal unfilled composite resin sealants

Treatment:

Other: Giomer

Optiguard

Experimental group

Description:

Optiguard unfilled composite resin sealant

Treatment:

Other: Giomer