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NCT Number: NCT07334509

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

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

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Key information

Conditions

Class II Dental Restorations

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Simplified Nano hybrid composite

Device

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

Conventional, multi shade nano, hybrid composite

Device

Traditional, multi shaded nano, hybrid, composite risen

Primary outcomes

  1. Marginal adaptation assessed using modified USPHS criteria

    Time frame: At baseline after six months after 1 year

    Marginal 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Acronym: FSC-HPC-GC

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 12, 2026
Registry last updated
Jan 12, 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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