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This study will verify the effect of the application of a substance (10% sodium hypoclorite -NaOCL) in dentin on noncarious cervical lesions, with the aim of increasing the longevity of the restorations performed in this type of lesion.
The hypothesis of the present study is that the application of deproteinization solution after acid etching does not influence the failure rate of the restorations.
The purpose of this study will be to evaluate the failure rates of composite restorations of non-carious cervical lesions (NCCL) performed with or without the pre-treatment with 10% sodium hypochlorite (NaOCl) on etched dentin.
A randomized controlled split-mouth and double blind clinical trial will be carried out. Patients with at least two NCCL will be selected. Each patient will be received at least one pair of composite restorations (Filtek Z350/3M ESPE), bonded either with 2 techniques: control (acid etching + placebo solution for 60 seconds + Adper Single Bond 2/3M ESPE) or experimental (acid etching + 10% NaOCl for 60 seconds + Adper Single Bond 2). A calibrated examiner will be evaluated the restorations (baseline, 6-, 12-, 24- and 36-month) using the FDI criteria. The primary outcome is retention of the restoration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium hypochlorite | Experimental | Dentin pre-treatment with a experimental solution (sodium hupochlorite), after the dentin acid etching |
|
| Water | Placebo Comparator | Application of water (placebo) after dentin acid etching |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium hypochlorite | Procedure | Application of 10% sodium hypochlorite (60 seconds) after the etching procedure and before the adhesive system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Retention rates of the restoration | Patients will be reevaluated at each specified time point and all restoration sites will be evaluated to check if the restoration will be still in place, or if it is missing, or if there is partial retention | 6, 12, 24, 36 and 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Post-operative sensitivity | At each time-point, patients will be recalled and interviewed regarding any symptom related to each restorations placed. | 6, 12, 24, 36 and 60 months |
| Change from baseline in marginal staining rates |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maximiliano Cenci, PhD | School of Dentistry, Federal University of Pelotas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of Pelotas - School of Dentistry | Pelotas | Rio Grande do Sul | 96015560 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20628774 | Background | Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14. | |
| 28237629 |
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| ID | Term |
|---|---|
| D012973 | Sodium Hypochlorite |
| D014867 | Water |
| ID | Term |
|---|---|
| D006997 | Hypochlorous Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D010087 | Oxides |
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Double Blind
| Water | Procedure | Treatment of acid etched dentin with sterilized water for 60 s before adhesive system application |
|
At each time-point, patients will be recalled and restorations will be reassessed in order to record changes in the rates of marginal staining, using the World Dental Federation (FDI) criteria for restorations assessment (Hickel et al 2010).
| 6, 12, 24, 36 and 60 months |
| Favetti M, Schroeder T, Montagner AF, Correa MB, Pereira-Cenci T, Cenci MS. Effectiveness of pre-treatment with chlorhexidine in restoration retention: A 36-month follow-up randomized clinical trial. J Dent. 2017 May;60:44-49. doi: 10.1016/j.jdent.2017.02.014. Epub 2017 Feb 22. |
| 35584331 | Derived | Favetti M, Schroeder T, Montagner AF, Moraes RR, Pereira-Cenci T, Cenci MS. NaOCl Application after Acid Etching and Retention of Cervical Restorations: A 3-Year Randomized Clinical Trial. Oper Dent. 2022 May 1;47(3):268-278. doi: 10.2341/20-166-C. |
| D017601 |
| Oxygen Compounds |
| D017670 | Sodium Compounds |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |