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

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

Detailed Description
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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.

Official Title
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Clinical Evaluation of White Spot Lesions Treated by S-PRG Coating Material and Resin Sealants in Comparison With Resin Infiltration by Using Spectrophotometer and Laser Fluorescence. (A Randomized Controlled Trial) (WSLs)

Conditions
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White Spot Lesion

Intervention / Treatment
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* Other: Giomer
* Other: Two composite resin sealants


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Icon resin infiltration material<br>Smooth surface resin infiltration comprises three steps for resin infiltration; Icon etch, Icon dry, and Icon infiltrant | Other: Giomer<br>* fluoride-releasing coating material containing surface reaction-type pre-reacted glass-ionomer (S-PRG) fillers<br>* Other names: PRG Barrier Coat;Other: Two composite resin sealants<br>* Unfilled composite resin sealants<br>* Other names: Permaseal and Optiguard;|
| Experimental: PRG Barrier Coat<br>fluoride-releasing coating material containing surface reaction-type pre-reacted glass-ionomer (S-PRG) fillers | Other: Two composite resin sealants<br>* Unfilled composite resin sealants<br>* Other names: Permaseal and Optiguard;|
| Experimental: Permaseal composite resin sealant<br>Permaseal unfilled composite resin sealants | Other: Giomer<br>* fluoride-releasing coating material containing surface reaction-type pre-reacted glass-ionomer (S-PRG) fillers<br>* Other names: PRG Barrier Coat;|
| Experimental: Optiguard<br>Optiguard unfilled composite resin sealant | Other: Giomer<br>* fluoride-releasing coating material containing surface reaction-type pre-reacted glass-ionomer (S-PRG) fillers<br>* Other names: PRG Barrier Coat;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patients tooth color change | Color change with Vita Easyshade When the Delta E increased, it consider esthetic improving | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patients tooth caries lesion state | Laser fluorescence score Assessing of carious lesions state of the lesions by Diagnodent Minimum score is 0, while maximum score is 20 When score is decreased it consider positive results | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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white spot lesions, ICON, S-PRG, DIAGNOdent