title: One-step partial or complete caries removal and bonding with antibacterial or traditional self-etch adhesives: study protocol for a randomized controlled trial.
abstract: 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).
  
  
  
  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.
  
  
  
  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.
  
  
  
  ClinicalTrials.gov Identifier NCT02286388 . Registered in November 2014.
authors.affiliation: Université Lyon 1 and Hospices Civils de Lyon, LMI UMR CNRS, 5615, Lyon, France. cyril.villat@univ-lyon1.fr.|Université Lyon 1. UFR d'Odontologie, 11 rue Guillaume Paradin, 69372, Lyon Cedex 08, France. cyril.villat@univ-lyon1.fr.
authors.forename: Cyril
authors.identifier: 0000-0001-8282-0624
authors.initials: C
authors.lastname: Villat
authors.affiliation: Université Paris Descartes and Assistance Publique des Hôpitaux de Paris, URB2i, EA 4462, Paris, France.
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Attal
authors.affiliation: Université de Nice Sophia Antipolis and CHU de Nice, Mines Paris Tech, CEMEF, UMR, CNRS 7635, Nice, France.
authors.forename: Nathalie
authors.initials: N
authors.lastname: Brulat
authors.affiliation: Université Paris Descartes and Assistance Publique des Hôpitaux de Paris, EA 2496, Paris, France.
authors.forename: Franck
authors.initials: F
authors.lastname: Decup
authors.affiliation: Université d'Auvergne Clermont-Ferrand and CHU de Clermont-Ferrand, CROC, EA 4847, Clermont-Ferrand, France.
authors.forename: Sophie
authors.initials: S
authors.lastname: Doméjean
authors.affiliation: Université Paris Descartes and Assistance Publique des Hôpitaux de Paris, URB2i, EA 4462, Paris, France.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Dursun
authors.affiliation: Université Paris Descartes and Assistance Publique des Hôpitaux de Paris, URB2i, EA 4462, Paris, France.
authors.forename: Hélène
authors.initials: H
authors.lastname: Fron-Chabouis
authors.affiliation: Université d'Aix-Marseille and Assistance Publique des Hôpitaux de Marseille, BioSanté, EA 4203, Marseille, France.
authors.forename: Bruno
authors.initials: B
authors.lastname: Jacquot
authors.affiliation: Université de Nice Sophia Antipolis and CHU de Nice, URB2i, EA 4462, Nice, France.
authors.forename: Michèle
authors.initials: M
authors.lastname: Muller Bolla
authors.affiliation: Université Paris Diderot and Assistance Publique des Hôpitaux de Paris, LMI UMR CNRS, 5615, Paris, France.
authors.forename: Nelly
authors.initials: N
authors.lastname: Plasse-Pradelle
authors.affiliation: Université Lyon 1 and Hospices Civils de Lyon, LBBE UMR CNRS, 5558, Lyon, France.
authors.forename: Laurent
authors.initials: L
authors.lastname: Roche
authors.affiliation: Université Lyon 1 and Hospices Civils de Lyon, LBBE UMR CNRS, 5558, Lyon, France.
authors.forename: Delphine
authors.initials: D
authors.lastname: Maucort-Boulch
authors.affiliation: Université Lyon 1 and Hospices Civils de Lyon, LBBE UMR CNRS, 5558, Lyon, France.
authors.forename: Patrice
authors.initials: P
authors.lastname: Nony
authors.affiliation: Université Lyon 1 and Hospices Civils de Lyon, LMI UMR CNRS, 5615, Lyon, France.
authors.forename: Kerstin
authors.initials: K
authors.lastname: Gritsch
authors.affiliation: Université de Reims Champagne Ardenne and CHU de Reims, LISM, EA4695, Reims, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Millet
authors.affiliation: Université Lyon 1 and Hospices Civils de Lyon, LBBE UMR CNRS, 5558, Lyon, France.
authors.forename: François
authors.initials: F
authors.lastname: Gueyffier
authors.affiliation: Université Lyon 1 and Hospices Civils de Lyon, LMI UMR CNRS, 5615, Lyon, France.
authors.forename: Brigitte
authors.initials: B
authors.lastname: Grosgogeat
mesh_terms: D000134:Acid Etching, Dental / Q000009:adverse effects; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002985:Clinical Protocols; D001840:Dental Bonding / Q000009:adverse effects / Q000379:methods*; D003731:Dental Caries / Q000000981:diagnostic imaging / Q000382:microbiology / Q000628:therapy*; D003738:Dental Cements / Q000009:adverse effects / Q000627:therapeutic use*; D003785:Dental Pulp Capping / Q000009:adverse effects / Q000379:methods*; D003804:Dentin / Q000000981:diagnostic imaging / Q000187:drug effects* / Q000382:microbiology / Q000601:surgery*; D005260:Female; D005602:France; D006801:Humans; D008297:Male; D008875:Middle Aged; D057872:Pulp Capping and Pulpectomy Agents / Q000009:adverse effects / Q000627:therapeutic use*; D011670:Pulpectomy / Q000009:adverse effects / Q000379:methods*; D011861:Radiography, Dental; D018401:Sample Size; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D003738:Dental Cements; D057872:Pulp Capping and Pulpectomy Agents
keywords: Cavity preparation; Composite resins; Deep carious lesion; Dental adhesives; Partial caries removal; Permanent dentition; Pulp capping; Randomized controlled trial