Clinical Performance of Universal Adhesive with and Without Acid Resistant Silane Coupling Agent in Carious Cervical Lesions :A Randomized Controlled Trial
| Registry | NCT06572124 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 80 (Estimated) |
| Sponsor | Cairo University (Other) |
| Conditions | Carious Lesion, Cervical Caries |
| Interventions | universal adhesive without Acid resistant silane coupling agent, universal adhesive with Acid resistant silane coupling agent (Procedure) |
| Dates | start 2024-09-01 (estimated), primary completion 2026-04-30 (estimated), completion 2026-04-30 (estimated), first posted 2024-08-26, last updated 2024-09-04 |
| Locations | 1 site in Egypt |
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Evaluation of composite restorations done in carious cervical lesions restored by a conventional universal adhesive in comparison to a universal adhesive that contains and resistant silane coupling agent according to the Modified United States Public Health Service (USPHS) criteria over 18 months.
The presence of acidic monomers in the bottle during storage can lead to the hydrolysis of silane contained in universal adhesives, potentially reducing its effectiveness and causing instability,The acid resistant silane coupling agent has a protective structure against attacks from acidic monomers. Therefore, long-term storage stability can be expected by suppressing hydrolysis. The protective structure is removed when the concentration of acidic monomers increases by air drying after application. This activates ARS, exerting the silane coupling effect.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Universal adhesive without acid resistant silane coupling agent | Active comparator | Procedure: universal adhesive without Acid resistant silane coupling agent | Universal adhesive with normal silane (comparator) After the acid etching and rinsing and drying step, the universal adhesive with normal silane will be actively applied for 20 second , then light cured for 20 seconds then the restoration will be placed |
| Universal adhesive with acid resistant silane coupling agent | Experimental | Procedure: universal adhesive with Acid resistant silane coupling agent | Universal adhesive with acid resistant silane coupling agent (Intervention) After the acid etching and rinsing and drying step, the universal adhesive with acid resistant silane coupling agent will be actively applied for 20 second , then light cured for 20 seconds then the restoration will be placed |
Sex: All, ages: 21 Years to 67 Years, accepts healthy volunteers
Inclusion Criteria: * Participants Inclusion: • Adults aging from 21-67 years old who were in need of restoration of at least one notch-shaped cervical lesion * Teeth Inclusion: * Vital teeth with carious cervical lesions in incisors , canines ,premolars\& molars Exclusion Criteria: * Participants Exclusion: * Patients with fewer than 20 teeth * Poor oral hygiene * Uncontrolled periodontal disease * Xerostomia * Known allergy to resin-based materials * Medically compromised, pregnant, or breast-feeding * Teeth Exclusion: * Non vital teeth * Teeth that are out of occlusion * Previously restored teeth
| Facility | City | Country | Status |
|---|---|---|---|
| Cairo University | Cairo | Egypt |