Randomized Clinical Trial of Occlusal Sealant

Impact of the Intermediary Layer on Sealant Retention: A Randomized 24-month Clinical Trial

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02589743

Enrollment

Registered

2015-10-28

Start date

2003-04-30

Completion date

2005-06-30

Last updated

2015-10-28

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

Conditions

Dental Caries

Keywords

clinical trial, pit and fissure sealants, tooth eruption, retention, adhesive system, intermediary layer

Brief summary

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.

Detailed 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.

Interventions

DEVICESealant

Application of preventive agent

DEVICEAdhesive and Sealant

Application of preventive agent and technique for control moisture

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

6 Years to 10 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Sealant retention and prevention of dental caries assessed by defined clinical scoring system	6-mouth	Clinical scoring system: adapted criteria proposed by Feigal et al. (2000)

Outcome results

None listed

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