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

NCT ID: NCT07334509

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-15
• Study Completion Date: 2027-01-15

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

Conditions

Class II Dental Restorations

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

conventional multi shaded nano hybrid composite

This group will receive the conventional multi shaded nano hybrid composite

Group Type: ACTIVE_COMPARATOR

Conventional, multi shade nano, hybrid composite

Intervention Type: DEVICE

Traditional, multi shaded nano, hybrid, composite risen

shaded nano hybrid composite

Participants receive the simplified shaded nano hybrid composite restoration

Group Type: EXPERIMENTAL

Simplified Nano hybrid composite

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Conventional, multi shade nano, hybrid composite

Traditional, multi shaded nano, hybrid, composite risen

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Raoh Kareem

Master's Degree Candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

CONS-3-7-5

Identifier Type: -

Identifier Source: org_study_id