NCT05550116

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

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)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Al-Azhar University · Academic / Other
• Sex: All
• Age: 19 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• White Spot Lesion

Interventions

Type	Name	Description
OTHER	Giomer	fluoride-releasing coating material containing surface reaction-type pre-reacted glass-ionomer (S-PRG) fillers
OTHER	Two composite resin sealants	Unfilled composite resin sealants

Timeline

• Start date: 2021-08-11
• Primary completion: 2022-08-30
• Completion: 2022-10-11
• First posted: 2022-09-22
• Last updated: 2022-09-26

Locations

1 site across 1 country: Egypt