NCT06884813 Clinical Evaluation of Color-Adjusting Composite Resin Following In-Office Dental Bleaching
| NCT ID | NCT06884813 |
| Status | Recruiting |
| Phase | — |
| Sponsor | King Abdullah University Hospital |
| Condition | Composite Resins |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-03-10 |
| Primary Completion | 2026-05-01 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
One challenge faced by dental professionals is that, unlike natural tooth structure, composite restorations do not lighten when exposed to bleaching agents. As a result, functional restorations may need replacement after bleaching to match the newly whitened teeth. However, replacing a composite restoration can lead to unnecessary removal of tooth structure, potentially weakening the tooth and increasing its susceptibility to further iatrogenic damage. This study will investigate the ability of Omnichroma restorations to shade-match tooth structure after bleaching. The null hypotheses will be: 1. Single-shade RBC will not exhibit similar shade and optical behavior to conventional RBC across all anterior restorations following bleaching. 2. Patient satisfaction regarding color blending between the restoration and tooth structure will not differ according to the type of material used. 3. Dentist satisfaction regarding color blending between the restoration and tooth structure will not differ according to the type of material used.
Eligibility Criteria
Inclusion Criteria: 1. Patients who are willing to come back for follow-up appointments. 2. Patients who are willing to sign an informed consent form. 3. Patients with well documented clinical records and have at least two anterior restorations (both Omnichroma and conventional multi-shade nanohybrid composite.) 4. Patients aged 18 years or older. 5. Patients with good oral hygiene 6. Patients with vital teeth. 7. Patients who are willing to have the restorations replaced later if necessary if there is a color mismatch after bleaching treatment. Exclusion Criteria: 1. Individuals with severe bruxism or periodontal disease. 2. Patients with non-vital teeth restored with composite fillings. 3. Patients with severe tooth discoloration. 4. Patients with fluorosis or tetracycline staining. 5. Heavy smokers. 6. Pregnant or nursing women. 7. Patients undergoing orthodontic treatment. 8. Patients with enamel or dentin deformations.