Clinical Evaluation of White Spot Lesions Treated by S-PRG Material and Composite Sealants in Comparison With ICON

White Spot Lesions Clinical Trial

Official title:

Clinical Evaluation of White Spot Lesions Treated by Surface Pre-reacted Glass Filler Coating Material and Composite Sealants in Comparison With Icon Resin Infiltration by Using Laser Fluorescence and Spectrophotometer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05562856
• Other study ID #: 350/466/08/10/19
• Status: Completed
• Phase: N/A
• Start date: January 20, 2020
• Est. completion date: December 3, 2021

Study information

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

Clinical Trial Summary

Dental caries is the primary cause of tooth loss and oral diseases. Dental decay is a continuous pathological process with loss of tooth minerals, demineralization, which involves the destruction of tooth structure from acids. The first sign of early active demineralization is white spot lesions (WSLs) on the tooth surface, meanwhile, subsurface active mineral decomposition.

Description:

Deposition of minerals depends on the equilibrium between demineralization and remineralization which may happen as a natural repair mechanism. The aim of this trial is to comparatively evaluate the efficacy of surface pre-reacted glass filler (S-PRG) Barrier Coat coating material against the Icon resin infiltration in the ability to improve the caries lesion state of the WSLs along 1 year. Laser fluorescence was used to compare the two materials to evaluate the caries progression. PRG Barrier Coat group showed immediate significant improvement in LF scores in demineralization progress and inhibition of caries progression with a significant improved effect. S-PRG Barrier Coat was clinically successful strategy in inhibition of caries and improve remineralization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 3, 2021
• Est. primary completion date: December 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 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

• White Spot Lesions

Intervention

Combination Product:
• surface pre-reacted glass filler coating material
the ability to improve the aesthetic appearance (masking) and caries lesion state of the WSLs

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	Assessments of caries lesion state of WSLs:	Assessing of carious lesions state of WSLs, was performed by using Diagnodent pen to record the progression or regression of caries by time. The assessment of the WSLs demineralization condition took place before intervention (baseline) [T0], immediately after intervention [T1], 3 months later [T2] ,6 months later [T3] and 1 year later [T4].	1 year
Secondary	Assessment of color change of WSLs:	The difference in color of the WSLs were performed by Vita Easyshade V at the five distinct times: before intervention (baseline) [T0], immediately after intervention [T1], 3 months later [T2] ,6 months later [T3] and 1 year later [T4].	1 year