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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05550116
Enrollment
20
Registered
2022-09-22
Start date
2021-08-11
Completion date
2022-10-11
Last updated
2022-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

White Spot Lesion

Keywords

white spot lesions, ICON, S-PRG, DIAGNOdent

Brief 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.

Interventions

OTHERGiomer

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

OTHERTwo composite resin sealants

Unfilled composite resin sealants

Sponsors

Al-Azhar University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
19 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
patients tooth color change1 yearColor change with Vita Easyshade When the Delta E increased, it consider esthetic improving

Secondary

MeasureTime frameDescription
patients tooth caries lesion state1 yearLaser 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026