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Clinical Evaluation of a Simplified-Shade Nano-Hybrid Composite With Full-Coverage Silane Coating and High-Performance Pulverized Fillers

Clinical Evaluation of a Simplified-Shade Nano-Hybrid Composite With Full-Coverage Silane Coating and High-Performance Pulverized Fillers Versus Conventional Multi-Shade Nano- Hybrid Composite in Direct Restoration of Posterior Proximal Carious Lesions After a 12- Month Follow-Up Period Using USPHS Criteria: A Randomized Controlled Clinical Trial

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07334509
Acronym
FSC-HPC-GC
Enrollment
50
Registered
2026-01-12
Start date
2026-01-15
Completion date
2027-01-15
Last updated
2026-01-12

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

Conditions

Class II Dental Restorations

Brief summary

The goal of this clinical trial is to evaluate simplified, shade, non-hybrid composite versus conventional multi Shade nano hybrid composite in class two restorations and reevaluate after one year follow up It's aim to answer Which composite has superior, anatomic form, color, match marginal, integrity, postoperative sensitivity, surface texture, and recurrent caries Researcher will compare the two composites And the participants will Have the restorations in posterior teeth and get a follow up after 12 months

Interventions

DEVICESimplified Nano hybrid composite

It's a simplified shade system for dental composite that is nano hybrid with full coverage saline coating and high performance pulverized fillers

DEVICEConventional, multi shade nano, hybrid composite

Traditional, multi shaded nano, hybrid, composite risen

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes

Inclusion criteria

* healthy human * age ranging from18-64 years with a class two posterior restoration * a fairly good oral hygiene * teeth should be indicated for direct composite restoration * teeth with vital pulp no symptoms of irreversible pulpitis * patient who are willing to follow up after 12 months * patient who have signed the informed consent

Exclusion criteria

* people under 18 years old or over 64 years old * people with disabilities * people with bad oral hygiene * patient with systematic disease that could be affecting oral health * cavities reaching the pulp * people with periodontal diseases * patient with parafunctional habits such as bruxism * patient who are allergic to the restoration * patients who are unwilling to follow after 12 months

Design outcomes

Primary

MeasureTime frameDescription
Marginal adaptation assessed using modified USPHS criteriaAt baseline after six months after 1 yearMarginal adaptation of the restorations will be clinically evaluated using the Modified United States Public Health Service (USPHS) criteria by a calibrated examiner. The scoring system includes the following categories: * Alpha (Score = 1): Excellent marginal adaptation, no visible gap * Bravo (Score = 2): Clinically acceptable marginal discrepancy * Charlie (Score = 3): Clinically unacceptable marginal defect requiring replacement The minimum score is 1 (best outcome) and the maximum score is 3 (worst outcome). Lower scores indicate better marginal adaptation, while higher scores indicate poorer marginal adaptation.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026