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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05562856
Enrollment
20
Registered
2022-10-03
Start date
2020-01-20
Completion date
2021-12-03
Last updated
2022-10-04

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

Conditions

White Spot Lesions

Brief 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.

Detailed 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.

Interventions

COMBINATION_PRODUCTsurface pre-reacted glass filler coating material

the ability to improve the aesthetic appearance (masking) and caries lesion state of the WSLs

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
20 Years to 40 Years
Healthy volunteers
No

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
Assessments of caries lesion state of WSLs:1 yearAssessing 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 \[T4\].

Secondary

MeasureTime frameDescription
Assessment of color change of WSLs:1 yearThe 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 \[T4\].

Countries

Egypt

Outcome results

None listed

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