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The purpose of this study is to evaluate the clinical effectiveness of non-carious cervical lesions (NCCLs) restored with two self-etching adhesive systems applied with or without selective enamel etching.
The purpose of this study is to evaluate the clinical effectiveness of non-carious cervical lesions (NCCLs) restored with two self-etching adhesive systems: Clearfil SE Bond (Kuraray Noritake, Japan) and Xeno V + (Dentsply De Trey, Germany) applied with or without 36% phosphoric acid enamel etching. Assessments were at baseline, 3, 6, 12, 18 and 24 months of clinical service.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clearfil SE Bond Etch (CSE-E) | Active Comparator | CSE-E (n=28): After shade selection, teeth were restored under relative isolation. Lesions were cleaned with pumice and water in a rubber cup followed by rinsing and drying. An enamel bevel of 1-2 mm was prepared with a diamond bur operated in a high-speed handpiece under air-water spray. Enamel margins were selectively etched with 36% phosphoric acid for 15s and subsequently thoroughly rinsed and air-dried. Adhesive system was applied according to manufacturers' instructions and light-cured with an LED for 10s. NCCLs were restored incrementally with a microhybrid composite resin. Increments were light cured for 20s. Afterwards, retraction cord was removed and finishing and polishing were performed with rubber points. Selective enamel etching with 36% phosphoric acid |
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| Xeno V+ Etch (XV-E) | Active Comparator | XV-E (n=28): After shade selection, teeth were restored under relative isolation. Lesions were cleaned with pumice and water in a rubber cup followed by rinsing and drying. An enamel bevel of 1-2 mm was prepared with a diamond bur operated in a high-speed handpiece under air-water spray. Enamel margins were selectively etched with 36% phosphoric acid for 15s and subsequently thoroughly rinsed and air-dried. Adhesive system was applied according to manufacturers' instructions and light-cured with an LED for 10s. NCCLs were restored incrementally with a microhybrid composite resin. Increments were light cured for 20s. Afterwards, retraction cord was removed and finishing and polishing were performed with rubber points. Selective enamel etching with 36% phosphoric acid |
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| Clearfil SE Bon Non-etch (CSE-NE) | Active Comparator | CSE-NE (n=28): After shade selection, teeth were restored under relative isolation. Lesions were cleaned with pumice and water in a rubber cup followed by rinsing and drying. An enamel bevel of 1-2 mm was prepared with a diamond bur operated in a high-speed handpiece under air-water spray. Adhesive system was applied according to manufacturers' instructions and light-cured with an LED for 10s. NCCLs were restored incrementally with a microhybrid composite resin. Increments were light cured for 20s. Afterwards, retraction cord was removed and finishing and polishing were performed with rubber points. No selective enamel etching with 36% phosphoric acid |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selective enamel etching with 36% phosphoric acid | Drug | Etch: selective 36% phosphoric acid enamel etching |
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| Measure | Description | Time Frame |
|---|---|---|
| Restoration retention rate as measured by modified U.S. Public Health Service evaluation criteria at baseline, 3, 6, 12, 18 and 24 months | Baseline, 3, 6, 12, 18 and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Restoration marginal integrity as measured by modified U.S. Public Health Service evaluation criteria at baseline, 3, 6, 12, 18 and 24 months | Baseline, 3, 6, 12, 18 and 24 months | |
| Restoration marginal staining as measured by modified U.S. Public Health Service evaluation criteria at baseline, 3, 6, 12, 18 and 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| André F Reis | University of Guarulhos | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15668328 | Background | De Munck J, Van Landuyt K, Peumans M, Poitevin A, Lambrechts P, Braem M, Van Meerbeek B. A critical review of the durability of adhesion to tooth tissue: methods and results. J Dent Res. 2005 Feb;84(2):118-32. doi: 10.1177/154405910508400204. | |
| 15765956 | Background | De Munck J, Vargas M, Iracki J, Van Landuyt K, Poitevin A, Lambrechts P, Van Meerbeek B. One-day bonding effectiveness of new self-etch adhesives to bur-cut enamel and dentin. Oper Dent. 2005 Jan-Feb;30(1):39-49. |
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| ID | Term |
|---|---|
| C030242 | phosphoric acid |
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| Xeno V+ Non-etch (XV-NE) | Active Comparator | XV-NE (n=28): After shade selection, teeth were restored under relative isolation. Lesions were cleaned with pumice and water in a rubber cup followed by rinsing and drying. An enamel bevel of 1-2 mm was prepared with a diamond bur operated in a high-speed handpiece under air-water spray. Adhesive system was applied according to manufacturers' instructions and light-cured with an LED for 10s. NCCLs were restored incrementally with a microhybrid composite resin. Increments were light cured for 20s. Afterwards, retraction cord was removed and finishing and polishing were performed with rubber points. No selective enamel etching with 36% phosphoric acid |
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| No selective enamel etching with 36% phosphoric acid | Drug | Non-etch: without phosphoric acid selective enamel etching |
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| Clearfil SE Bond | Device |
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| Xeno V | Device |
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| Baseline, 3, 6, 12, 18 and 24 months |
| Secondary caries as measured by modified U.S. Public Health Service evaluation criteria at baseline, 3, 6, 12, 18 and 24 months | Baseline, 3, 6, 12, 18 and 24 months |
| Post-operative sensitivity as measured by modified U.S. Public Health Service evaluation criteria at baseline, 3, 6, 12, 18 and 24 months | Baseline, 3, 6, 12, 18 and 24 months |
| Pulp vitality as measured by modified U.S. Public Health Service evaluation criteria at baseline, 3, 6, 12, 18 and 24 months | Baseline, 3, 6, 12, 18 and 24 months |
| 12638771 | Background | Perdigao J, Geraldeli S. Bonding characteristics of self-etching adhesives to intact versus prepared enamel. J Esthet Restor Dent. 2003;15(1):32-41; discussion 42. doi: 10.1111/j.1708-8240.2003.tb00280.x. |
| 17432395 | Background | Peumans M, De Munck J, Van Landuyt K, Lambrechts P, Van Meerbeek B. Five-year clinical effectiveness of a two-step self-etching adhesive. J Adhes Dent. 2007 Feb;9(1):7-10. |
| 15766585 | Background | Van Meerbeek B, Kanumilli P, De Munck J, Van Landuyt K, Lambrechts P, Peumans M. A randomized controlled study evaluating the effectiveness of a two-step self-etch adhesive with and without selective phosphoric-acid etching of enamel. Dent Mater. 2005 Apr;21(4):375-83. doi: 10.1016/j.dental.2004.05.008. |
| 17302950 | Background | Reis AF, Bedran-Russo AK, Giannini M, Pereira PN. Interfacial ultramorphology of single-step adhesives: nanoleakage as a function of time. J Oral Rehabil. 2007 Mar;34(3):213-21. doi: 10.1111/j.1365-2842.2006.01656.x. |
| 16315023 | Background | Cvar JF, Ryge G. Reprint of criteria for the clinical evaluation of dental restorative materials. 1971. Clin Oral Investig. 2005 Dec;9(4):215-32. doi: 10.1007/s00784-005-0018-z. No abstract available. |