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

Al-Azhar University

Status: Completed

Conditions: White Spot Lesions

Treatments: Combination Product: surface pre-reacted glass filler coating material

Study type: Interventional

Funder types: Other

Identifiers

NCT05562856

350/466/08/10/19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 4 patient groups

surface pre-reacted glass filler coating material

Experimental group

Description:

surface pre-reacted glass filler coating material used to remineralize WSLs

Treatment:

Combination Product: surface pre-reacted glass filler coating material

micro-invasive resin infiltration technique (Icon)

Active Comparator group

Description:

micro-invasive resin infiltration technique (Icon) in the ability to improve caries lesion state (LF scores) and making the WSLs

Treatment:

Combination Product: surface pre-reacted glass filler coating material

Permaseal resin

Experimental group

Description:

Permaseal composite resin sealant as micro-invasive resin infiltration technique in the ability to improve caries lesion state (LF scores) and making the WSLs

Treatment:

Combination Product: surface pre-reacted glass filler coating material

Optiguard resin

Experimental group

Description:

Optiguardcomposite resin sealant as micro-invasive resin infiltration technique in the ability to improve caries lesion state (LF scores) and making the WSLs

Treatment:

Combination Product: surface pre-reacted glass filler coating material