NCT03614819

Laser Used in the Treatment of Hypomineralized Occlusal Lesions in Teeth Enamel Affected by MIH

Laser Used in the Treatment of Hypomineralized Occlusal Lesions in Teeth Enamel Affected by MIH: a Randomized Controlled Clinical Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 6 Years – 10 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dental Enamel Hypoplasia

Interventions

Type	Name	Description
PROCEDURE	Diode laser group	Prophylaxis of the selected region for the study with Robson brush and prophylactic paste, washing and drying, followed by application of diode laser (Sirolaser, Sirona Dental Systems GmbH, Bensheim, Germany) with wavelength of 970 nm +/- 10 nm, maximum power of 7 W CW, 1mW guide beam and 320μm optical fiber. Irradiation will be performed on the entire occlusal surface in contact mode, with power of 0.7 W (energy of 70 mJ) and frequency of 10 Hz for 30 seconds, having an energy density of 222.82 J / cm2. The FieldMaxII-TOP power meter (Coherent, Inc, USA) will be used prior to and after the applications. The laser will be applied in a sweeping motion throughout the affected surface, the fiber being maintained positioned perpendicular to the occlusal surface throughout the movement. The irradiation time will be standardized in 30 seconds.
PROCEDURE	Glass Ionomer Sealing Group	Prophylaxis of the selected region for the study with Robson brush and prophylactic paste, washing and drying with cotton balls, followed by relative insulation with cotton rollers of the tooth in question, application of acid polyacrylic for 15 seconds throughout the surface, light drying with cotton ball, insertion of the high viscosity glass ionomer (Equia Forte in capsule - GC) through a specific applicator, after loss of the gloss of the digital pressure material with Vaseline for due drainage and surface protection of the material, removal of the excess, checking the occlusion with carbon paper, occlusal adjustments if necessary, superficial protection with petroleum jelly.

Timeline

• Start date: 2018-08-30
• Primary completion: 2021-06-30
• Completion: 2022-08-30
• First posted: 2018-08-03
• Last updated: 2023-05-12

Locations

1 site across 1 country: Brazil