Clinical trial NCT03235960: Efficacy of Glass-ionomer Fissure Sealants
Official title: Clinical Efficacy of Glass-ionomer Fissure Sealants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fissure Sealant
Glass-ionomer Cement
Permanent Molar
Lead sponsor: Association of Paediatric and Preventive Dentists of Serbia
Sponsor class: OTHER
First posted: 2017-08-01
Enrollment: 500
Sex: ALL
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy children who appeared for a regular dental examination

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.

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

Primary outcomes:
measure: absence of caries
timeFrame: every 12 months during 13 years
measure: retention of sealant
timeFrame: every 12 months during 13 years
Secondary outcomes:
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: University of Belgrade, School of Dental Medicine
Study officials:
affiliation: University of Belgrade, School of Dental Medicine
name: Dejan Markovic, PhD
role: PRINCIPAL_INVESTIGATOR
References: