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Clinical Trial Summary

Background: Nowadays an increase in the incidence of teeth affected by molar incisor hypomineralisation (MIH) has been observed. There are several treatment modalities that depend on the degree of severity of the defect, such as preventive procedures, restorative and even dental extractions. However, these changes may affect the retention and longevity of restorative materials. Therefore, the aim of this study is to evaluate the use of diode laser irradiation for the treatment of occlusal surfaces of moderate lesions in permanent first molars affected with MIH as a preventive method for dental caries and occlusal wear, besides verifying the discomfort of the treatment by patients. Methods: For this, a controlled and randomized study, with parallel groups, will be conducted comparing the treatment with diode laser and sealing with high viscosity glass ionomer cement in the teeth affected by the MIH. Participants will be assessed at baseline and after 1 week, 1, 6, 12, 18 and 24 months. As the main outcome, the presence of dentin caries lesion and /or occlusal surface wear included in the study with dentin involvement will be evaluated. A visual examination for caries detection will be done using the ICDAS, using the index based on classification in the United States Public Health Service - Modified (USPH) for evaluation of sealed teeth and impression of impacted teeth for quantitative analysis of the lesions. Other outcomes such as patient satisfaction with treatment, patient discomfort, impact on quality of life and participant perception, as well as the duration and cost of treatment, as well as their cost-efficacy, will also be evaluated. Multilevel statistical analyzes will be performed to verify the efficacy of Diode laser treatment compared to sealing, in addition to possible factors associated with this efficacy.


Clinical Trial Description

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Study Design


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NCT number NCT03614819
Study type Interventional
Source University of Sao Paulo
Contact
Status Completed
Phase N/A
Start date August 30, 2018
Completion date August 30, 2022

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