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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorCairo University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • PermaSeal™, Ultradent Products Inc., USA

    Other intervention

    Unfilled resin surface sealant

  • OPTIGLAZE™, GC, Tokyo, Japan

    Other intervention

    Unfilled resin surface sealant

  • Conventional finishing and polishing protocol

    Other intervention

    Restorations without resin surface sealants.

Treatment groups

25 Participants
are divided into 3 treatment groups
Group A: Unfilled resin surface sealant groupExperimental treatment 1 intervention
Group B: Nano-filled resin surface sealant groupExperimental treatment 1 intervention
Group C: Class V Restorations without resin surface sealants.Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Marginal discoloration

Modified USPHS criteria

Time frame
2 years

Secondary outcomes

1

Color match, Secondary caries, Postoperative sensitivity, Surface texture , Marginal adaptation

Modified USPHS criteria

Time frame
2 years
2

Color stability

by VITA Easyshade®

Time frame
2 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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