Impact of different restorative treatments for deep caries lesion in primary teeth (CEPECO 1) \u2013 study protocol for a noninferiority randomized clinical trial

Gabriela Seabra Quennehen Da Silva,Anna Carolina Volpi Mello-Moura,Tamara Kerber Tedesco,Thais Gimenez,Daniela Prócida Raggio,Gabriela Fernanda Ribeiro Machado,Isabela Floriano

doi:10.1186/s12903-018-0703-3

Gabriela Seabra Quennehen Da Silva, Anna Carolina Volpi Mello-Moura + Show 5 more

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https://doi.org/10.1186/s12903-018-0703-3

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Abstract

BackgroundDue to the lack of evidence to determine the best treatment for deep cavitated caries lesions in primary molars, the search for an effective restorative technique, which results in a minimal discomfort to patients, and reduce the time needed for the treatment, becomes relevant. The objective of this randomized clinical trial was to evaluate if high-viscosity glass ionomer cement (HVGIC) restorations is noninferior to restoration with calcium hydroxide cement associated with HVGIC for treatment of deep lesions in primary molars, as well as the impact of the treatments on cost and discomfort of the patient.MethodsA non-inferiority randomized clinical trial with two parallels arms (1:1) will be conducted. Children with 4 to 8 years will be selected at Clinic of Pediatric Dentistry at Ibirapuera University. 108 teeth will be randomized into two groups: (1) Calcium hydroxide cement associated with HVGIC and (2) HVGIC restoration. Primary outcome will be considered the pulp vitality and to be evaluated after 6, 12, 18 and 24 months by two calibrated examiners. Survival of restorations will also be evaluated in the equal intervals. The duration of dentals treatment and the cost of all materials used will be considered for estimating of cost-efficacy of each treatment. Individual discomfort will be measured after each dental procedure using the Wong-Baker’s Facial Scale. For the primary outcome, Kaplan-Meier survival and the long-rank test will be used to comparison between the groups. Cox regression will be performed to assess the influence of variables on the outcome. For all analyzes, the significance level is set at 5%.DiscussionBased on the philosophy of ART, our hypothesis is that the HVGIC restoration is a possible approach to restore the deep caries lesion with pulp vitality without the use of rubber dam and anesthesia.Trial registrationClinicaltrials.gov registration NCT02903979. Registered on June 9th 2016.

Highlights

Due to the lack of evidence to determine the best treatment for deep cavitated caries lesions in primary molars, the search for an effective restorative technique, which results in a minimal discomfort to patients, and reduce the time needed for the treatment, becomes relevant
Based on the technique of selective dentin caries removal, indirect pulp capping is performed in a single dental session and aims to use a biocompatible material to protect the dentin-pulp complex, such as calcium hydroxide cement [8], which would have as benefits the reduction of the number of remaining bacteria as well as a possible dentinal response leading to the formation of a reparative dentin [10]
This study aims as primary outcome to compare the pulp vitality of two types of treatment for deep caries lesions in primary molars (HVGIC restoration and restoration with calcium hydroxide cement associated with high-viscosity glass ionomer cement (HVGIC)) by a non-inferiority randomized clinical trial with two parallel arms

Summary

Introduction

Due to the lack of evidence to determine the best treatment for deep cavitated caries lesions in primary molars, the search for an effective restorative technique, which results in a minimal discomfort to patients, and reduce the time needed for the treatment, becomes relevant. With the better biological understanding of the disease, as well as the importance of the etiological and modifiers factors, new concepts were developed for treating of these lesions, especially those already cavitated, in order to use less invasive restorative techniques and preventive approaches [5]. These changes in the paradigms allow, the accomplishment of more conservative cavity preparations, with significant preservation of enamel and dentin, since it is possible only the removal of the irreversibly affected tissues by the caries lesion [6, 7]. Recent studies still have suggested the use of inert materials for this protection because they would have the capacity to arrest the caries process [11] or, even, the direct restoration of the cavity with adhesive systems associated with resin composite [12] or resin-modified glass ionomer cement [13]

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