Child, Dental Caries, Fissure Sealants, Healthy Volunteers, Permanent Molars
Conditions
Keywords
Dental caries, Fissure sealant, Glass ionomer, Resin-based sealant, Moisture-tolerant, Retention, Permanent molar, Children, Split-mouth design, Randomized clinical trial, Marginal adaptation, USPHS criteria
Brief summary
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.
Detailed description
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.
Interventions
DEVICEGlass ionomer-based fissure sealant
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).
DEVICEResin-based fissure 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).
Sponsors
Gulcin Bulut
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
6 Years to 7 Years
Healthy volunteers
Yes
Inclusion criteria
* Children aged 6-7 years * Children who are systemically healthy and classified as ASA I and II16 * Children whose parents and themselves have agreed to attend the study and follow-up visits throughout the study period * Children who have established oral hygiene habits
Exclusion criteria
* Children whose caregivers did not sign the informed consent form, and patients who wished to withdraw or for whom the treatment protocol was not properly followed. * Children who have restorations, cavitated surfaces or developmental defects and hypoplasia on the permanent first molar teeth to be treated. * Medically compromised and children who need special treatment. * History of adverse reactions to any restorative materials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sealant retention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Marginal adaptation | 1, 6, 12, 18, and 24 months | Evaluation of the marginal adaptation of the sealant to the tooth structure using modified USPHS criteria. |
| Marginal discoloration | 1, 6, 12, 18, and 24 months | Assessment of any marginal discoloration of the sealant using modified USPHS criteria. |
| Presence of caries | 1, 6, 12, 18, and 24 months | Detection of carious lesions on sealed occlusal surfaces throughout the follow-up period. |
Countries
Turkey (Türkiye)
Outcome results
None listed