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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Cairo University
- Enrollment
- 50
- Primary Endpoint
- Marginal adaptation assessed using modified USPHS criteria
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Raoh Kareem
Master's Degree Candidate
Cairo University