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This study aims to evaluate the effect of chlorhexidine digluconate (CRX) application in etched dentin on the retention of noncarious cervical lesions restorations.
A randomized controlled split-mouth and blind trial will be carried out. Patients with at least two non-carious cervical lesions (NCL) will be selected. NCL will be randomly assigned according the type of teeth (incisors, canine or pre-molars) into two groups: control or experimental group (application of 2% CRX for 60 seconds after the acid etching procedure). Class V restorations will be performed out with an etch-and-rinse adhesive system (Adper Single Bond 2-3M ESPE) and a composite resin (Filtek Z350-3M ESPE) according the manufacture instructions, by previously trained operators. The restorations will be evaluated by a calibrate examiner at 1 week (baseline), and 6-month, 12-month and 24-month, using the World Dental Federation (FDI) criteria. The outcome is retention of the restoration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chlorhexidine | Experimental | Dentin pre-treatment with a experimental solution (chlorhexidine), after the dentin acid etching |
|
| Water | Placebo Comparator | Application of water (placebo) after dentin acid etching. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment with chlorhexidine | Procedure | Application of 2% chlorhexidine digluconate (60 seconds) after the etching procedure and before the adhesive system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Retention rates of the restoration at 24 months | 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 and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Post-operative sensitivity at 6-month | At each time-point, patients will be recalled and interviewed regarding any symptom related to each restorations placed. | baseline and 6-month |
| Change from baseline in marginal staining rates at 6. 12 and 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maximiliano Cenci, PhD | School of Dentistry-UFPel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Dentistry, Federal University of Pelotas | Pelotas | Rio Grande do Sul | 96015-560 | 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. |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D002710 | Chlorhexidine |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Water pre-treatment | 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 and 24 months |