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

Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE

Original Publication: [London] : BioMed Central, 2006-

Anti-Bacterial Agents/*therapeutic use ; Dental Bonding/*methods ; Dental Caries/*therapy ; Dental Cements/*therapeutic use ; Dental Pulp Capping/*methods ; Dentin/*drug effects ; Dentin/*surgery ; Pulp Capping and Pulpectomy Agents/*therapeutic use ; Pulpectomy/*methods; Acid Etching, Dental/adverse effects ; Adolescent ; Adult ; Aged ; Aged, 80 and over ; Anti-Bacterial Agents/adverse effects ; Child ; Clinical Protocols ; Dental Bonding/adverse effects ; Dental Caries/diagnostic imaging ; Dental Caries/microbiology ; Dental Cements/adverse effects ; Dental Pulp Capping/adverse effects ; Dentin/diagnostic imaging ; Dentin/microbiology ; Female ; France ; Humans ; Male ; Middle Aged ; Pulp Capping and Pulpectomy Agents/adverse effects ; Pulpectomy/adverse effects ; Radiography, Dental ; Sample Size ; Time Factors ; Treatment Outcome ; Young Adult

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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Keywords: Cavity preparation; Composite resins; Deep carious lesion; Dental adhesives; Partial caries removal; Permanent dentition; Pulp capping; Randomized controlled trial

ClinicalTrials.gov NCT02286388

0 (Anti-Bacterial Agents)
0 (Dental Cements)
0 (Pulp Capping and Pulpectomy Agents)

Date Created: 20160817 Date Completed: 20180206 Latest Revision: 20220410

20250114

PMC4986347

10.1186/s13063-016-1484-0

27527342