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More info
You can access this
clinical trial
if you have
Deep Caries Lesion of Primary Teeth
and you are
between 4 and 8
years old
The phase for this study is not defined.
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The purpose

In front of a lack of evidence to determine the best treatment for deep cavitated carious lesions, the search for an effective restorative technique, which results in a least possible discomfort to patients, and reduce the time needed for the restorative treatment, if becomes relevant. The objective of this randomized clinical trial to evaluate the efficacy of high viscosity glass ionomer cement restorations (HVGIC) compared to restoration with calcium hydroxide restoration associated with high viscosity glass ionomer cement (HVGIC) for treatment of deep lesions in primary molars, as well as the impact of treatment in the criteria focused on the patient as well as cost-efficacy of the techniques . Children with 4 to 8 years will be selected randomly at the Clinic for Children at the University Ibirapuera of Dentistry. 108 teeth will be randomized into two groups: (1) restoration with calcium hydroxide cement associated with HVGIC and (2) HVGIC restoration. The restorations will be evaluated after 6, 12 and 24 months by two trained examiners blinded to the treatments. The efficacy of each treatment is measured by four main outcomes, which are: (1) criteria related to the effectiveness of the restorative treatment (2) criteria focused on the patient and (3) cost-efficacy. For comparison between the two groups will be used the Kaplan-Meier survival and the long-rank test. Cox regression is performed the assessment of the influence of some other variable results. For all analyzes, the significance level is set at 5%.

Provided treatments

  • Other: HVGIC
  • Other: Indirect pulp capping

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT02903979. The sponsor of the trial is Universidade Ibirapuera and it is looking for 108 volunteers for the current phase.
Official trial title: