Randomized Clinical Trial of Occlusal Sealant

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.

Completed

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Key information

Conditions

Dental Caries Exanthema Skin Diseases Skin and Connective Tissue Diseases Stomatognathic Diseases Tooth Demineralization Tooth Diseases Van der Woude syndrome

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Sealant

Device

Application of preventive agent

Adhesive and Sealant

Device

Application of preventive agent and technique for control moisture

Primary outcomes

Sealant retention and prevention of dental caries assessed by defined clinical scoring system

Time frame: 6-mouth

Clinical scoring system: adapted criteria proposed by Feigal et al. (2000)

Sponsors and collaborators

Lead sponsor

University of Campinas, Brazil

Other

Collaborators

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Registry information

Official study title

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

Important dates

Study start: 2003
Primary completion: 2003
Study completion: 2005
First posted: Oct 28, 2015
Registry last updated: Oct 28, 2015

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.

Published trials that share one or more normalized conditions with this study.

Completed