An interventional study of HVGIC and Indirect pulp capping in Deep Caries Lesion of Primary Teeth, sponsored by Universidade Ibirapuera. Completed at 1 site in Brazil. Open to participants aged 4 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-11.
Sponsored by Universidade Ibirapuera · Not applicable, Interventional, and Treatment
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%.
Universidade Ibirapuera is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Restorations with only HVGIC in deep caries lesion of primary teeth.
Other: HVGIC
Indirect pulp capping with calcium hydroxide cement, restored with HVGIC:
Other: Indirect pulp capping
In experimental group, the researches will be performed a restoration, after partial caries removal, with high viscosity glass ionomer cement in the teeth with deep caries lesion.
In control group, the researches will be performed a indirect pulp capping with calcium hydroxide cement and high viscosity glass ionomer cement in the teeth with deep caries lesion.
Pulp Vitality
To evaluate the survival of different restorative treatments considering the pulp vitality.
Time frame: Up to 24 months
Wong-Baker scale to discomfort
To evaluate the discomfort of different restorative treatments by a Wong-Baker scale.
Time frame: Immediately to restoration procedure.
Cost-efficacy analysis by total value of treatment in relation to efficacy
To evaluate the cost-efficacy of different restorative treatments by total value in dollar of treatment in relation to efficacy. The researchers would like to analyze that a treatment of low cost show the similar efficacy of a high cost treatment.
Time frame: Up to 24 months
Restoration longevity
To evaluate the restoration longevity by clinical examination.
Time frame: Up to 24 months.
Caries progression
To evaluate the caries progression by radiography.
Time frame: Up to 24 months.
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Universidade Ibirapuera