Randomized Clinical Trial of Occlusal Sealant

University of Campinas, Brazil

Status and phase: Completed; Phase 2

Conditions: Dental Caries

Treatments: Device: Adhesive and Sealant; Device: Sealant

Study type: Interventional

Funder types: Other

Identifiers

NCT02589743

1

Details and patient eligibility

About

This study assessed long-term impact of tooth Eruption Stages (ES) on sealant retention on occlusal surfaces previously coated with intermediary bonding layer and it determined caries incidence outcome evolved. The treatment were (sealant/technique): Fluroshield; Helioseal Clear Chroma; Single Bond and Fluroshield; Excite and Helioseal Clear Chroma.

Full description

The greatest risk of sealant failure occurs soon after tooth eruption, when contamination with saliva and gingival fluid is almost inevitable. The use of an intermediate bonding layer between humidity contaminated enamel and sealant can improve bond strength, reduces microleakage, and enhances resin flow into fissures. The benefit of primer and adhesive layer beneath the sealant seems to be based on a combination of moisture-chasing effects of the hydrophilic primer, increased flow dispersion imparted by the less viscous primer and adhesive and increased flexibility of the combined and polymerized primer/adhesive/resin complex once reaction is complete.

Enrollment: 65 patients

Sex: All

Ages: 6 to 10 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Four caries-free erupted first molar permanent teeth; no systemic diseases and no dental material allergies.

Exclusion criteria

• Carious or absence first molar permanent teeth.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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65 participants in 4 patient groups

Fluroshield - F (Sealant)

Active Comparator group

Description:

Pit and fissure sealing using only sealant

Treatment:

Device: Sealant

Single Bond and F (Adhesive and Sealant)

Experimental group

Description:

Pit and fissure sealing using adhesive and sealant

Treatment:

Device: Adhesive and Sealant

Helioseal Clear Chroma - H (Sealant)

Active Comparator group

Description:

Pit and fissure sealing using only sealant

Treatment:

Device: Sealant

Excite and H (Adhesive and Sealant)

Experimental group

Description:

Pit and fissure sealing using adhesive and sealant

Treatment:

Device: Adhesive and Sealant