Efficacy of Glass-ionomer Fissure Sealants

Sponsor
Association of Paediatric and Preventive Dentists of Serbia (Other)
Overall Status
Unknown status
CT.gov ID
NCT03235960
Collaborator
(none)
500
1
163
3.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: glass-ionomer fissure sealant

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Clinical Efficacy of Glass-ionomer Fissure Sealants
Actual Study Start Date :
Jan 1, 2004
Anticipated Primary Completion Date :
Aug 1, 2017
Anticipated Study Completion Date :
Aug 1, 2017

Outcome Measures

Primary Outcome Measures

  1. absence of caries [every 12 months during 13 years]

    absence of caries on sealed tooth surfaces

  2. retention of sealant [every 12 months during 13 years]

    complete or partial retention

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 14 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Belgrade, School of Dental Medicine Belgrade Serbia

Sponsors and Collaborators

  • Association of Paediatric and Preventive Dentists of Serbia

Investigators

  • Principal Investigator: Dejan Markovic, PhD, University of Belgrade, School of Dental Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dejan Markovic, professor, Association of Paediatric and Preventive Dentists of Serbia
ClinicalTrials.gov Identifier:
NCT03235960
Other Study ID Numbers:
  • 001-04
First Posted:
Aug 1, 2017
Last Update Posted:
Aug 1, 2017
Last Verified:
Jul 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No

Study Results

No Results Posted as of Aug 1, 2017