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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07618013
Enrollment
25
Registered
2026-06-01
Start date
2026-07-01
Completion date
2028-08-01
Last updated
2026-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Color Stability, Marginal Discoloration

Brief summary

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®.

Interventions

OTHERPermaSeal™, Ultradent Products Inc., USA

Unfilled resin surface sealant

OTHEROPTIGLAZE™, GC, Tokyo, Japan

Unfilled resin surface sealant

OTHERConventional finishing and polishing protocol

Restorations without resin surface sealants.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Marginal discoloration2 yearsModified USPHS criteria

Secondary

MeasureTime frameDescription
Color match, Secondary caries, Postoperative sensitivity, Surface texture , Marginal adaptation2 yearsModified USPHS criteria
Color stability2 yearsby VITA Easyshade®

Contacts

CONTACTNanees Ayman Hassan Aly
nanees.ayman@dentistry.cu.edu.eg01210974750

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 6, 2026