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Sponsor study identifier
interventional
122
1 country
1
Study Start
August 30, 2018
Actual (reported)Primary Completion
June 30, 2021
Actual (reported)Study Completion
August 30, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 30, 2022
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 14, 2018
Actual (reported)August 3, 2018
Actual (reported)August 30, 2018
Actual (reported)June 30, 2021
Actual (reported)August 30, 2022
Actual (reported)Evaluation of clinical signs change in the progression of caries lesion and / or occlusal surface wear during the follow-up
The main outcome will be the presence of changes in clinical signs in relation to the progression of carious lesions and / or occlusal surface wear included in the study with dentin involvement through ICDAS, photographs, radiographic examination and the index based on the classification in the United States Public Health Service - Modified (USPH).
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
Satisfaction in relation the treatment using VAS scale
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.
Self-reported discomfort using Wong Backer face scale after the treatment
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]
Hypersensitivity to dentin
This evaluation will be performed before treatment, 1 week, 1, 6, 12, 18 and 24 months after inclusion
Evaluation of patient's perception of satisfaction regarding their oral health
For this, an external examiner will apply the questionnaire prior to randomization and on 1, 12 and 24 month return visits.
Costs of each consultation performed through study completion
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)
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.
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.
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.
Luciana Pion Antonio
Ribeirão Preto, São Paulo, 14040-904, Brazil
122 participants (actual enrollment reported by the registry).
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.
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First Submitted
June 14, 2018
First Posted
August 3, 2018
Study Start
August 30, 2018
Actual (reported)Primary Completion
June 30, 2021
Actual (reported)Study Completion
August 30, 2022
Actual (reported)Last Updated
May 12, 2023
Record last verified: 2023-05
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Source: ClinicalTrials.gov.
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