One-step partial or complete caries removal and bonding with antibacterial or traditional self-etch adhesives: study protocol for a randomized controlled trial

Abstract Background Current concepts in conservative dentistry advocate minimally invasive dentistry and pulp vitality preservation. Moreover, complete removal of carious dentin in deep carious lesions often leads to pulp exposure and root canal treatment, despite the absence of irreversible pulp inflammation. For years, partial caries removal has been performed on primary teeth, but little evidence supports its effectiveness for permanent teeth. Furthermore, the recent development of new antibacterial adhesive systems could be interesting in the treatment of such lesions. The objectives of this study are to compare the effectiveness of partial versus complete carious dentin removal in deep lesions (primary objective) and the use of an antibacterial versus a traditional two-step self-etch adhesive system (main secondary objective). Methods/Design The DEep CAries Treatment (DECAT) study protocol is a multicenter, randomized, controlled superiority trial comparing partial versus complete caries removal followed by adhesive restoration. The minimum sample size required is 464 patients. Two successive randomizations will be performed (allocation ratio 1:1): the first for the type of excavation (partial versus complete) and the second (if no root canal treatment is required) for the type of adhesive (antibacterial versus traditional). For the two objectives, the outcome is the success of the treatment after 1 year, measured according to a composite outcome of five FDI criteria: material fracture and retention, marginal adaptation, radiographic examination (including apical pathologies), postoperative sensitivity and tooth vitality, and carious lesion recurrence. Discussion The study will investigate the interest of a conservative approach for the management of deep carious lesions in terms of dentin excavation and bioactive adhesive systems. The results may help practitioners achieve the most efficient restorative procedure to maintain pulp vitality and increase the restoration longevity. Trial registration ClinicalTrials.gov Identifier NCT02286388 . Registered in November 2014.

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PID https://www.doi.org/10.6084/m9.figshare.c.3634952
PID https://www.doi.org/10.6084/m9.figshare.c.3634952.v1
URL https://dx.doi.org/10.6084/m9.figshare.c.3634952
URL https://dx.doi.org/10.6084/m9.figshare.c.3634952.v1
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Author Villat, Cyril, 0000-0001-8282-0624
Author Attal, Jean-Pierre
Author Brulat, Nathalie
Author Decup, Franck
Author Doméjean, Sophie
Author Dursun, Elisabeth
Author Fron-Chabouis, Hélène
Author Jacquot, Bruno
Author Bolla, Michèle Muller
Author Plasse-Pradelle, Nelly
Author Roche, Laurent
Author Maucort-Boulch, Delphine, 0000-0003-0042-7787
Author Nony, Patrice
Author Gritsch, Kerstin
Author Millet, Pierre
Author Gueyffier, François
Author Grosgogeat, Brigitte
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Collected From Datacite
Hosted By figshare
Publication Date 2019-10-24
Publisher figshare
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keyword FOS: Biological sciences
system:type dataset
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Source https://science-innovation-policy.openaire.eu/search/dataset?datasetId=dedup_wf_001::97a92ba0ca28d25974e296d679ce509a
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Last Updated 7 January 2021, 20:21 (CET)
Created 7 January 2021, 20:21 (CET)