A Two-year Study Evaluating the Surface-sealed Cervical Resin Composite Restorations in Comparison With the Non-sealed Restorations
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PermaSeal™, Ultradent Products Inc., USA, OPTIGLAZE™, GC, Tokyo, Japan, Conventional finishing and polishing protocol.
- Who it may be relevant to
- Registry conditions: Marginal Discoloration, Color Stability. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Effectiveness of Using Surface Sealants on Cervical Resin Composite Restorations in Comparison With Non-sealed Restorations: A 2-year Randomized Clinical Trial
Overview
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
- Other PermaSeal™, Ultradent Products Inc., USA
Unfilled resin surface sealant - Other OPTIGLAZE™, GC, Tokyo, Japan
Unfilled resin surface sealant - Other Conventional finishing and polishing protocol
Restorations without resin surface sealants.
Primary outcome measures
- Marginal discoloration [Time frame: 2 years]
Secondary outcome measures (2)
- Color match, Secondary caries, Postoperative sensitivity, Surface texture , Marginal adaptation [Time frame: 2 years]
- Color stability [Time frame: 2 years]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- • Amin, A. H., Yaakob, M. H., Nasir, W. Z. W., & Al-Kadhim, A. H. A. (2018). Evaluation the correlation between age, gender, and the incidence of cervical lesions. Journal of Clinical Research in Dentistry, 1(1). • Attia, R. M., Sobhy, E. M., & Abd El Hameed, M. E. S. (2023). Micro-Hardness and Surface Roughness of Bulk-Fill Composite Resin: Effect of Surface Sealant Application and Two Bleaching
Identifiers
NCT: NCT07618013 · Surface sealants on composite