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Efficacy of Glass-ionomer Fissure Sealants

Clinical Efficacy of Glass-ionomer Fissure Sealants

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03235960
Enrollment
500
Registered
2017-08-01
Start date
2004-01-01
Completion date
2017-08-01
Last updated
2017-08-01

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

Conditions

Fissure Sealant, Glass-ionomer Cement, Permanent Molar

Brief summary

Despite numerous techniques for enamel protection, occlusal caries still remains a problem. Sealing pits and fissures is considered to be an effective way of preventing caries development. Glass-ionomer cements are mainly recommended for pits and fissures sealing for two reasons. First, they are less susceptible to moisture which allows their use in noncooperable children or in partially erupted teeth where isolation could be a problem, and secondly, due to their potential to act as a fluoride reservoir making enamel more resistant to demineralisation. The purpose of the study is to clinically examine the caries-preventive effect of a glass-ionomer material for fissure protection in newly erupted permanent molars in children with low, moderate, and high caries-risk.

Detailed description

Despite numerous techniques for enamel protection, such as topical fluorides, calcium phosphate-based remineralization systems, xylitol, etc., occlusal caries still remains a problem. A carious lesion occurs in pits and fissures of occlusal surfaces primarily due to their specific anatomy, which is considered to be an ideal site for the retention of bacteria and food remnants rendering mechanical means of debridement inaccessible. Sealing pits and fissures is considered to be an effective way of preventing caries development. Today, there is a wide spectrum of available sealing materials. Glass-ionomer cements are mainly recommended for pits and fissures sealing for two reasons. First, they are less susceptible to moisture which allows their use in noncooperable children or in partially erupted teeth where isolation could be a problem, and secondly, due to their potential to act as a fluoride reservoir making enamel more resistant to demineralisation. During last decades, glass-ionomer cements of different physical and chemical properties were used for pits and fissure sealing which probably contributed to variances in their clinical efficacy. The purpose of the study is to clinically examine the caries-preventive effect of a glass-ionomer material for fissure protection in newly erupted permanent molars in children with low, moderate, and high caries-risk.

Interventions

DEVICEglass-ionomer fissure sealant

The encapsulated glass-ionomer cement for fissure protection was applied onto the selected permanent molar according to the manufacturer's instruction

Sponsors

Association of Paediatric and Preventive Dentists of Serbia
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
5 Years to 14 Years
Healthy volunteers
Yes

Inclusion criteria

* at least one recently erupted permanent molar with sound pits and fissures * healthy patients * possibility to perform a dental treatment * willing to participate in the study

Exclusion criteria

* teeth with an obvious cavity, with a restoration or a sealant completely or partially presented in the fissure system * medically compromised patients * non cooperative patients * not willing to participate in the study

Design outcomes

Primary

MeasureTime frameDescription
absence of cariesevery 12 months during 13 yearsabsence of caries on sealed tooth surfaces
retention of sealantevery 12 months during 13 yearscomplete or partial retention

Countries

Serbia

Outcome results

None listed

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