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Completed

NCT Number: NCT05562856

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

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.

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Key information

Conditions

White Spot Lesions

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mohamed Wakwak

Cairo, 11768, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

surface pre-reacted glass filler coating material

Combination Product

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

Primary outcomes

  1. Assessments of caries lesion state of WSLs:

    Time frame: 1 year

    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].

Secondary outcomes

  1. Assessment of color change of WSLs:

    Time frame: 1 year

    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].

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 3, 2022
Registry last updated
Oct 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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