Menu
Not yet recruiting NCT07334509

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

No phase Interventional Class II Dental 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: Simplified Nano hybrid composite, Conventional, multi shade nano, hybrid composite.
Who it may be relevant to
Registry conditions: Class II Dental Restorations. Basic parameters: 18 years — 64 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 →
Official 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

Overview

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

  • 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
  • Device Conventional, multi shade nano, hybrid composite
    Traditional, multi shaded nano, hybrid, composite risen

Primary outcome measures

  • Marginal adaptation assessed using modified USPHS criteria [Time frame: At baseline after six months after 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07334509 · CONS-3-7-5

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗