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Clinical Trials/NCT03235960
NCT03235960
Unknown
Not Applicable

Clinical Efficacy of Glass-ionomer Fissure Sealants

Association of Paediatric and Preventive Dentists of Serbia1 site in 1 country500 target enrollmentJanuary 1, 2004

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fissure Sealant
Sponsor
Association of Paediatric and Preventive Dentists of Serbia
Enrollment
500
Locations
1
Primary Endpoint
absence of caries
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2004
End Date
August 1, 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Association of Paediatric and Preventive Dentists of Serbia
Responsible Party
Principal Investigator
Principal Investigator

Dejan Markovic

professor

Association of Paediatric and Preventive Dentists of Serbia

Eligibility Criteria

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

Outcomes

Primary Outcomes

absence of caries

Time Frame: every 12 months during 13 years

absence of caries on sealed tooth surfaces

retention of sealant

Time Frame: every 12 months during 13 years

complete or partial retention

Study Sites (1)

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