About this trial
After finishing and polishing are completed, the tooth surface may exhibit microcracks and micro-irregularities that create a roughened surface, which may lead to plaque retention, gingival inflammation, and discoloration. The surface-penetrating sealant was introduced to fill micro-irregularities by capillary action, providing a uniform, regular surface and enhancing the surface smoothness. The application of unfilled low-viscosity surface sealants aims to enhance the luster, smoothness, and color stability of esthetic restorations and decrease stain absorption. They have low viscosity that enables them to easily spread and penetrate over these finished and polished surfaces, which may affect the life of the restoration positively. Additionally, it decreases surface porosity and creates a surface that is more thoroughly cured, improving the composite's stain resistance.
This prospective, parallel-group, randomized clinical study aims to compare the clinical effectiveness of using surface sealants on cervical resin composite restorations versus non-sealed restorations. Restorations will be assessed at baseline, 6, 12, 18, and 24 months using modified USPHS criteria. The primary outcome will be assessing marginal discoloration, and the secondary outcomes will be assessing color match, secondary caries, postoperative sensitivity, surface texture, and marginal adaptation. Color stability will be assessed by VITA Easyshade®.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients aged 18-55 years.
Patients with good oral hygiene (mild to moderate plaque accumulation).
Patients with asymptomatic class V cavities in permanent teeth.
Vital posterior teeth with class V carious cavities.
Disqualifiers
Patients who are unable to return for recall appointments.
Patients with poor oral hygiene.
Presence of abnormal oral, medical, or mental condition
Presence of any parafunctional habits.
Trial design
Parallel
Treatments tested in this trial
PermaSeal™, Ultradent Products Inc., USA
Other interventionUnfilled resin surface sealant
OPTIGLAZE™, GC, Tokyo, Japan
Other interventionUnfilled resin surface sealant
Conventional finishing and polishing protocol
Other interventionRestorations without resin surface sealants.
Treatment groups
Trial outcomes
Primary outcomes
Marginal discoloration
Modified USPHS criteria
Secondary outcomes
Color match, Secondary caries, Postoperative sensitivity, Surface texture , Marginal adaptation
Modified USPHS criteria
Color stability
by VITA Easyshade®
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: