Efficacy of Glass-ionomer Fissure Sealants

Fissure Sealant Clinical Trial

Official title:

Clinical Efficacy of Glass-ionomer Fissure Sealants

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03235960
• Other study ID #: 001-04
• Status: Active, not recruiting
• Phase: N/A
• First received: July 18, 2017
• Last updated: July 31, 2017
• Start date: January 1, 2004
• Est. completion date: August 1, 2017

Study information

• Verified date: July 2017
• Source: Association of Paediatric and Preventive Dentists of Serbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: August 1, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Fissure Sealant
• Glass-ionomer Cement
• Permanent Molar

Intervention

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

Locations

Country	Name	City	State
Serbia	University of Belgrade, School of Dental Medicine	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
Association of Paediatric and Preventive Dentists of Serbia

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	absence of caries	absence of caries on sealed tooth surfaces	every 12 months during 13 years
Primary	retention of sealant	complete or partial retention	every 12 months during 13 years