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

NCT07334509 | Not Yet Recruiting

• 1 other identifier: CONS-3-7-5
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Marginal adaptation assessed using modified USPHS criteria

  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

Study Arms (2)

conventional multi shaded nano hybrid composite

ACTIVE COMPARATOR

This group will receive the conventional multi shaded nano hybrid composite

Device: Conventional, multi shade nano, hybrid composite

shaded nano hybrid composite

EXPERIMENTAL

Participants receive the simplified shaded nano hybrid composite restoration

Device: Simplified Nano hybrid composite

Interventions

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

shaded nano hybrid composite

Conventional, multi shade nano, hybrid composite DEVICE

Traditional, multi shaded nano, hybrid, composite risen

conventional multi shaded nano hybrid composite

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's Degree Candidate

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: January 12, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 15, 2027
• Last Updated: January 12, 2026

Record last verified: 2025-12