A Two-year Study Evaluating the Surface-sealed Cervical Resin Composite Restorations in Comparison With the Non-sealed Restorations

Cairo University (CU)

Status: Begins enrollment this month

Conditions: Marginal Discoloration; Color Stability

Treatments: Other: OPTIGLAZE™, GC, Tokyo, Japan; Other: Conventional finishing and polishing protocol; Other: PermaSeal™, Ultradent Products Inc., USA

Study type: Interventional

Funder types: Other

Identifiers

NCT07618013

Surface sealants on composite

Details and patient eligibility

About

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®.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Participant Inclusion Criteria:

• 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.

Teeth inclusion criteria:

• Vital posterior teeth with class V carious cavities.
• Moderate cavities (ICDAS 3 & 4).
• Free from signs and symptoms of irreversible pulpitis and pulpal necrosis.
• Teeth with no or grade 1 mobility.

Participant Exclusion Criteria:

• 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.
• Patients with TMJ problems.

Teeth Exclusion Criteria:

• Periodontal disease that may affect the prognosis of the restoration or the tooth itself.
• Fractured or visibly cracked teeth.
• Presence of any developmental or formative defects.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25 participants in 3 patient groups

Unfilled resin surface sealant group

Experimental group

Description:

Patients with carious cervical lesions (class V) in the esthetic zone receiving resin composite restorations covered by the Unfilled resin surface sealant

Treatment:

Other: PermaSeal™, Ultradent Products Inc., USA

Nano-filled resin surface sealant group

Experimental group

Description:

Patients with carious cervical lesions (class V) in the esthetic zone receiving resin composite restorations covered by the Nano-filled resin surface sealant

Treatment:

Other: OPTIGLAZE™, GC, Tokyo, Japan

Class V Restorations without resin surface sealants.

Active Comparator group

Description:

Patients with carious cervical lesions (class V) in the esthetic zone receiving resin composite restorations not covered by the resin surface sealant

Treatment:

Other: Conventional finishing and polishing protocol