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

White Spot Lesion Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05550116
• Other study ID #: 2286488
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 11, 2021
• Est. completion date: October 11, 2022

Study information

• Verified date: September 2022
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: October 11, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Exanthema
• White Spot Lesion

Intervention

Other:
• Giomer
fluoride-releasing coating material containing surface reaction-type pre-reacted glass-ionomer (S-PRG) fillers
• Two composite resin sealants
Unfilled composite resin sealants

Locations

Country	Name	City	State
Egypt	Mohamed Wakwak	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patients tooth color change	Color change with Vita Easyshade When the Delta E increased, it consider esthetic improving	1 year
Secondary	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