Not Yet RecruitingNot Applicable

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

25 participantsStarted 2026-07

Plain-language 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®.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Marginal discoloration

Timeframe: 2 years

Trial details

NCT IDNCT07618013

SponsorCairo University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-07

Contact for this trial

Nanees Ayman Hassan Aly

01210974750 nanees.ayman@dentistry.cu.edu.eg

View on ClinicalTrials.gov More Marginal Discoloration trials