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Impact of Different Restorative Treatments for Deep Caries Lesion in Primary Teeth

NCT02903979 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2020-06-11

No results posted yet for this study

Summary

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%.

Conditions

  • Deep Caries Lesion of Primary Teeth

Interventions

OTHER

HVGIC

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.

OTHER

Indirect pulp capping

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.

Sponsors & Collaborators

  • Universidade Ibirapuera

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2018-03-31
Completion
2020-05-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02903979 on ClinicalTrials.gov