Clinical trial NCT03614819: Laser Used in the Treatment of Hypomineralized Occlusal Lesions in Teeth Enamel Affected by MIH
Official title: Laser Used in the Treatment of Hypomineralized Occlusal Lesions in Teeth Enamel Affected by MIH: a Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Enamel Hypoplasia
Keywords: Lasers
Dental enamel hypoplasia
Preventive dentistry
Dental caries
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 122
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Diode laser group Prophylaxis of the selected region for the study and 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 and frequency of 10 Hz for 30 seconds, having an energy density of 222.82 J / cm2.

Glass Ionomer Sealing Group Prophylaxis of the selected region for the study, 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.
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Children who present at the first permanent molar with occlusal surface affected with light or moderate severity of MIH
* Children between 6 and 10 years old

Exclusion Criteria:

* Teeth that present restorations
* Teeth that presente sealants
* Enamel malformations that are specific to some syndromes
* Hypomineralized enamel affected by the ingestion of fluoride during enamel development

Primary outcomes:
measure: Evaluation of clinical signs change in the progression of caries lesion and / or occlusal surface wear during the follow-up
timeFrame: All surfaces will be examined after previous cleaning with prophylactic paste and water and a Robson brush, with lighting and after air drying and 1, 6, 12, 18 and 24 months after
Secondary outcomes:
measure: Satisfaction in relation the treatment using VAS scale
timeFrame: This evaluation will be applied after 1 week of treatment, 1, 12 and 24 months and will not be identified by name and will be done in the absence of the operators so as not to restrain the subject from expressing their actual opinion.
measure: Self-reported discomfort using Wong Backer face scale after the treatment
timeFrame: This evaluation will be performed before starting the treatment with laser or with high viscosity glass ionomer and 2 minutes after the treatment is performed]
measure: Hypersensitivity to dentin
timeFrame: This evaluation will be performed before treatment, 1 week, 1, 6, 12, 18 and 24 months after inclusion
measure: Evaluation of patient's perception of satisfaction regarding their oral health
timeFrame: For this, an external examiner will apply the questionnaire prior to randomization and on 1, 12 and 24 month return visits.
measure: Costs of each consultation performed through study completion
timeFrame: The time spent in each of the sessions will be timed by an external examiner not participating in the exams, who will also note the number of visits of each participant. The data will be collected at all return visits (1 week, 1, 6, 12, 18 and 24 months)
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Luciana Pion Antonio
state: SP
Study officials:
References: