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NCT Number: NCT07618013

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

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®.

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Key information

Conditions

Marginal Discoloration Color Stability

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PermaSeal™, Ultradent Products Inc., USA

Other

Unfilled resin surface sealant

OPTIGLAZE™, GC, Tokyo, Japan

Other

Unfilled resin surface sealant

Conventional finishing and polishing protocol

Other

Restorations without resin surface sealants.

Primary outcomes

  1. Marginal discoloration

    Time frame: 2 years

    Modified USPHS criteria

Secondary outcomes

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

    Time frame: 2 years

    Modified USPHS criteria

  2. Color stability

    Time frame: 2 years

    by VITA Easyshade®

Study contacts

Contact information is provided by the study sponsor or research team.

Nanees Ayman Hassan Aly

CONTACT

[email protected]

01210974750

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Clinical Effectiveness of Using Surface Sealants on Cervical Resin Composite Restorations in Comparison With Non-sealed Restorations: A 2-year Randomized Clinical Trial

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 1, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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