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| ID | Type | Description | Link |
|---|---|---|---|
| TÄ°TCK-2023-067 | Other Identifier | Turkish Medicines and Medical Devices Agency |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glass Ionomer Sealant Arm | Active Comparator | In this arm, a high-viscosity glass ionomer-based fissure sealant (Fuji Triageâ„¢ Capsule, GC Corporation, Tokyo, Japan) was applied to one of the newly erupted permanent first molars of each participant using a split-mouth design. |
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| Resin-Based Sealant Arm | Active Comparator | In this arm, a moisture-tolerant resin-based fissure sealant (UltraSeal XT® Hydro, Ultradent Products Inc., South Jordan, UT, USA) was applied to the contralateral newly erupted permanent first molar of the same participant, using the split-mouth method. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glass ionomer-based fissure sealant | Device | 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 Triageâ„¢ Capsule (GC Corporation, Japan). |
| Measure | Description | Time Frame |
|---|---|---|
| Sealant retention | 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. | 1, 6, 12, 18, and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Marginal adaptation | Evaluation of the marginal adaptation of the sealant to the tooth structure using modified USPHS criteria. | 1, 6, 12, 18, and 24 months |
| Marginal discoloration | Assessment of any marginal discoloration of the sealant using modified USPHS criteria. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gulcin F Bulut, DDS, PhD | Dokuz Eylul University, Faculty of Dentistry, Department of Pediatric Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dokuz Eylul University, Faculty of Dentistry, Department of Pediatric Dentistry | Izmir | İzmir | 35340 | Turkey (Türkiye) |
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This study employed a split-mouth crossover design in which each participant received both interventions. One first permanent molar on the right or left side of the same dental arch was sealed with a glass ionomer-based sealant, while the contralateral molar on the opposite side of the same arch received a moisture-tolerant resin-based sealant. This design minimizes inter-subject variability and allows for a direct comparison within the same oral environment.
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| Resin-based fissure sealant | Device | 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). |
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| 1, 6, 12, 18, and 24 months |
| Presence of caries | Detection of carious lesions on sealed occlusal surfaces throughout the follow-up period. | 1, 6, 12, 18, and 24 months |
| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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