Dokuz Eylul University, Faculty of Dentistry, Department of Pediatric Dentistry
Izmir, İzmir, 35340, Turkey (Türkiye)
NCT Number: NCT07115290
This clinical study aims to compare the clinical performance of two different fissure sealant materials-glass ionomer and resin-based-when applied to newly erupted permanent first molars in children. The study evaluates which material provides better retention, marginal adaptation, and protection against dental caries over a 24-month period.
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Notify Me6 year–7 year
All sexes
Interventional
Not applicable
Izmir, İzmir, 35340, Turkey (Türkiye)
This randomized, split-mouth, clinical study was designed to compare the clinical effectiveness of two different fissure sealant materials-glass ionomer-based (Fuji Triage™ Capsule) and moisture-tolerant resin-based (UltraSeal XT® Hydro)-in newly erupted permanent first molars in children aged 6-7 years.
The study evaluates the retention rates, marginal adaptation, marginal discoloration, and the ability of each material to prevent dental caries over a 24-month follow-up period. A total of 70 teeth from 35 children were sealed using a split-mouth design, ensuring that each participant received both types of sealants on contralateral molars. Clinical evaluations were performed at 1, 6, 12, 18, and 24 months using modified United States Public Health Service (USPHS) criteria.
The goal of the study is to determine whether the moisture-tolerant resin-based material offers a clinical advantage in terms of sealant retention and caries prevention in a partially erupted, moisture-challenged clinical environment.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A high-viscosity, self-curing glass ionomer sealant used for the occlusal surfaces of newly erupted permanent molars. This material releases fluoride and is moisture-tolerant during application. The product used in this study was Fuji Triage™ Capsule (GC Corporation, Japan).
Other names: Fuji Triage, Glass ionomer fissure sealant, GC Fuji Triage, GIC sealant
A moisture-tolerant, light-cured resin-based fissure sealant designed for application to occlusal surfaces in partially erupted permanent molars. The material exhibits strong adhesion in moist conditions and forms a durable barrier against caries. The product used in this study was UltraSeal XT® Hydro (Ultradent Products Inc., USA).
Other names: UltraSeal XT Hydro, Moisture-tolerant resin sealant, Hydrophilic sealant
Time frame: 1, 6, 12, 18, and 24 months
Assessment of the retention of the fissure sealant material on the occlusal surface of the first permanent molars using modified USPHS criteria. Evaluated at 1, 6, 12, 18, and 24 months.
Time frame: 1, 6, 12, 18, and 24 months
Evaluation of the marginal adaptation of the sealant to the tooth structure using modified USPHS criteria.
Time frame: 1, 6, 12, 18, and 24 months
Assessment of any marginal discoloration of the sealant using modified USPHS criteria.
Time frame: 1, 6, 12, 18, and 24 months
Detection of carious lesions on sealed occlusal surfaces throughout the follow-up period.
Gulcin Bulut
Other
Acronym: FISSURE24
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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