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

January 9, 2026 updated by: Raoh Kareem, Cairo University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: conventional multi shaded nano hybrid composite
This group will receive the conventional multi shaded nano hybrid composite
Device: Conventional, multi shade nano, hybrid composite
Traditional, multi shaded nano, hybrid, composite risen
Experimental: shaded nano hybrid composite
Participants receive the simplified shaded nano hybrid composite restoration
Device: Simplified 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline after six months after 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 15, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

January 15, 2027

Study Registration Dates

First Submitted

December 17, 2025

First Submitted That Met QC Criteria

January 9, 2026

First Posted (Estimated)

January 12, 2026

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 9, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • CONS-3-7-5

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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