Interventions to Control Hypersensitivity Pain in Teeth With Insisive Molar Hypomineralization
NCT ID: NCT06426108
Last Updated: 2025-04-06
Study Results
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Basic Information
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COMPLETED
PHASE4
72 participants
INTERVENTIONAL
2024-07-01
2025-01-07
Brief Summary
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Detailed Description
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For the diagnosis of MIH, the investigators will employ the criteria outlined by the European Academy of Pediatric Dentistry, which includes assessment of demarcated opacities, post-eruptive enamel defects, atypical restorations, teeth lost due to MIH, and incompletely erupted teeth. The sample size was determined based on the anticipated outcome of pain reduction following treatment, with an expected 60% reduction. Calculation was conducted with a confidence level of 95% and a power of 80%.
Following the application of the inclusion and exclusion criteria, each group will consist of a total of 88 teeth, randomly assigned to one of four groups: GI, GII, GIII, and GIV. The interventions for each group will be as follows:
GI: Low-Intensity Laser 1J (10 seconds) + Fluoride Varnish. GII: Low-Intensity Laser 1J (10 seconds) + Placebo. GIII: Low-Intensity Laser 2J (20 seconds) + Fluoride Varnish. GIV: Low-Intensity Laser 2J (20 seconds) + Placebo.
To administer laser therapy, the investigators will utilize a low-intensity infrared diode laser (Therapy EC, DMC Equipamentos Ltda., São Carlos, Brazil) operating in continuous mode, emitting at a wavelength of 808 nm with a power output of 100 mW. The dosage will be set at either 1 or 2 Joules, with a fluence of 35 J/cm\^2. Both the operator and the patient will wear personal protective equipment (PPE) during the procedure. The tooth will be irradiated perpendicular to the tooth surface, targeting the cervical third of the buccal surface (both mesial and distal aspects), as well as the center of the lesion. Activation time will be either 10 or 20 seconds, corresponding to 1 or 2 Joules respectively, depending on the assigned group. To ensure consistency, even if the laser is activated for 1 Joule (equivalent to 10 seconds), the laser tip will be maintained in place for a standardized duration of 20 seconds, the maximum activation time, as confirmed by a stopwatch in all applications to ensure reliability.
As an adjunct to LBI, the investigators will use a fluoride varnish (FV) and a placebo varnish (PV) without the active ingredient, ensuring that they are in identical packaging with the same taste and texture. Both will maintain the same method of application. The FV used will be Duraphat® (22,600 ppm F, Colgate). The application of both FV and PV will be conducted according to each respective group. Application will be facilitated using a microbrush, spreading it over the entire lesion area for 30 seconds. After the interventions, patients will be instructed not to consume hard foods and to refrain from brushing their teeth for at least four hours following varnish application, adhering to the manufacturer's recommendations.
Following all tests, the data will undergo normality analysis (Shapiro-Wilk test) and homoscedasticity assessment (Levene's test) to determine the suitability of parametric statistics. Therefore, for all variables, one-way ANOVA will be employed, followed by Tukey's post-hoc test for group comparisons. Demographic data will be evaluated using Pearson's chi-square test. Friedman's test may be utilized for multiple comparisons (sensitivity assessments), and the Wilcoxon test for paired comparisons. Analyses will be conducted using the statistical software SPSS 12.0 (SPSS Inc., Chicago, IL, USA). All tests will be performed at a 95% confidence level (α = 0.05).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Low-Intensity Laser 1J + Fluoride Varnish
The tooth will undergo low-intensity laser irradiation in continuous mode, employing a wavelength of 808 nm, a power output of 100 mW, a dose of 1 Joule, and a fluence of 35 J/cm\^2. The laser will be positioned perpendicular to the tooth surface, targeting the cervical third of the vestibular surface (both mesial and distal aspects), as well as the center of the lesion, with an activation time of 1 Joule (equivalent to 10 seconds). In conjunction with the laser therapy, a fluoride varnish (Duraphat®, containing 22,600 ppm F, manufactured by Colgate) will be utilized as an adjuvant. Application will be facilitated using a microbrush, ensuring coverage over the entire extent of the lesion for 30 seconds. Following the interventions, patients will be advised to refrain from consuming hard foods and to postpone tooth brushing for at least four hours post-application of the varnish, adhering to the manufacturer's guidelines.
Fluoride Varnishes
the investigators will utilize a fluoride varnish with a concentration of 22,600 ppm F. The application will be facilitated using a microbrush, ensuring thorough coverage over the entire length of the lesion for a duration of 30 seconds. Following application, the varnish will be finished with water to create a film on the tooth surface. After completing the interventions, patients will receive instructions to refrain from consuming hard foods and to postpone tooth brushing for at least four hours, adhering to the manufacturer's recommendations.
Low-Intensity Laser 1J
The tooth will undergo low-intensity laser irradiation in continuous mode, employing a wavelength of 808 nm, a power output of 100 mW, a dose of 1 Joule, and a fluence of 35 J/cm\^2. The laser will be positioned perpendicular to the tooth surface, targeting the cervical third of the buccal surface (both mesial and distal aspects), as well as the center of the lesion.
Low-Intensity Laser 1J + Placebo
The tooth will be subjected to low-intensity laser irradiation in continuous mode, employing a wavelength of 808 nm, a power output of 100 mW, a dose of 1 Joule, and a fluence of 35 J/cm\^2. The laser will be positioned perpendicular to the tooth surface, targeting the cervical third of the vestibular surface (both mesial and distal aspects), as well as the center of the lesion, with an activation time of 1 Joule (equivalent to 10 seconds). As an adjunct to the laser therapy, a placebo varnish, devoid of the active ingredient (fluoride), will be utilized. The varnish will be applied with the assistance of a microbrush, ensuring coverage over the entire length of the lesion for 30 seconds. Following the interventions, patients will be advised to abstain from consuming hard foods and to postpone tooth brushing for at least four hours post-application of the varnish.
Varnishes placebo
the investigators will apply a placebo varnish without the active ingredient (fluoride), ensuring that it is packaged identically to the fluoride varnish and has the same taste and texture, thus maintaining consistency in application. The varnish will be applied using a microbrush, spreading it evenly over the entire length of the lesion for a duration of 30 seconds. Following the interventions, patients will receive instructions to avoid consuming hard foods and to delay tooth brushing for at least four hours after applying the varnish.
Low-Intensity Laser 1J
The tooth will undergo low-intensity laser irradiation in continuous mode, employing a wavelength of 808 nm, a power output of 100 mW, a dose of 1 Joule, and a fluence of 35 J/cm\^2. The laser will be positioned perpendicular to the tooth surface, targeting the cervical third of the buccal surface (both mesial and distal aspects), as well as the center of the lesion.
Low-Intensity Laser 2J + Fluoride Varnish
The tooth will undergo low-intensity laser irradiation in continuous mode, utilizing a wavelength of 808 nm, a power output of 100 mW, a dose of 2 Joules, and a fluence of 35 J/cm\^2. The laser will be positioned perpendicularly in contact with the tooth surface, targeting the cervical third of the vestibular surface (both mesial and distal aspects), as well as the center of the lesion, with an activation time of 2 Joules (equivalent to 20 seconds). As an adjunct to the laser therapy, a fluoride varnish (Duraphat®, containing 22,600 ppm F, manufactured by Colgate) will be utilized. The varnish application will be facilitated using a microbrush, ensuring coverage over the entire length of the lesion for 30 seconds. Following the interventions, patients will be instructed to refrain from consuming hard foods and to postpone tooth brushing for at least four hours after applying the varnish, in accordance with the manufacturer's recommendations.
Fluoride Varnishes
the investigators will utilize a fluoride varnish with a concentration of 22,600 ppm F. The application will be facilitated using a microbrush, ensuring thorough coverage over the entire length of the lesion for a duration of 30 seconds. Following application, the varnish will be finished with water to create a film on the tooth surface. After completing the interventions, patients will receive instructions to refrain from consuming hard foods and to postpone tooth brushing for at least four hours, adhering to the manufacturer's recommendations.
Low-Intensity Laser 2J
The tooth will undergo low-intensity laser irradiation in continuous mode, employing a wavelength of 808 nm, a power output of 100 mW, a dose of 2 Joules, and a fluence of 35 J/cm\^2. The laser will be positioned perpendicular to the tooth surface, targeting the cervical third of the buccal surface (both mesial and distal aspects), as well as the center of the lesion.
Low-Intensity Laser 2J + Placebo.
The tooth will undergo low-intensity laser irradiation in continuous mode, employing a wavelength of 808 nm, a power output of 100 mW, a dose of 2 Joules, and a fluence of 35 J/cm\^2. The laser will be positioned perpendicular to the tooth surface, targeting the third cervical region of the vestibular surface (both mesial and distal aspects), as well as the center of the lesion, with an activation time of 2 Joules (equivalent to 20 seconds). As an adjunct to the laser therapy, a placebo varnish, devoid of the active ingredient (fluoride), will be utilized.The varnish will be applied with the assistance of a microbrush, ensuring coverage over the entire length of the lesion for 30 seconds. Following the interventions, patients will be advised to abstain from consuming hard foods and to postpone tooth brushing for at least four hours post-application of the varnish.
Varnishes placebo
the investigators will apply a placebo varnish without the active ingredient (fluoride), ensuring that it is packaged identically to the fluoride varnish and has the same taste and texture, thus maintaining consistency in application. The varnish will be applied using a microbrush, spreading it evenly over the entire length of the lesion for a duration of 30 seconds. Following the interventions, patients will receive instructions to avoid consuming hard foods and to delay tooth brushing for at least four hours after applying the varnish.
Low-Intensity Laser 2J
The tooth will undergo low-intensity laser irradiation in continuous mode, employing a wavelength of 808 nm, a power output of 100 mW, a dose of 2 Joules, and a fluence of 35 J/cm\^2. The laser will be positioned perpendicular to the tooth surface, targeting the cervical third of the buccal surface (both mesial and distal aspects), as well as the center of the lesion.
Interventions
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Fluoride Varnishes
the investigators will utilize a fluoride varnish with a concentration of 22,600 ppm F. The application will be facilitated using a microbrush, ensuring thorough coverage over the entire length of the lesion for a duration of 30 seconds. Following application, the varnish will be finished with water to create a film on the tooth surface. After completing the interventions, patients will receive instructions to refrain from consuming hard foods and to postpone tooth brushing for at least four hours, adhering to the manufacturer's recommendations.
Varnishes placebo
the investigators will apply a placebo varnish without the active ingredient (fluoride), ensuring that it is packaged identically to the fluoride varnish and has the same taste and texture, thus maintaining consistency in application. The varnish will be applied using a microbrush, spreading it evenly over the entire length of the lesion for a duration of 30 seconds. Following the interventions, patients will receive instructions to avoid consuming hard foods and to delay tooth brushing for at least four hours after applying the varnish.
Low-Intensity Laser 1J
The tooth will undergo low-intensity laser irradiation in continuous mode, employing a wavelength of 808 nm, a power output of 100 mW, a dose of 1 Joule, and a fluence of 35 J/cm\^2. The laser will be positioned perpendicular to the tooth surface, targeting the cervical third of the buccal surface (both mesial and distal aspects), as well as the center of the lesion.
Low-Intensity Laser 2J
The tooth will undergo low-intensity laser irradiation in continuous mode, employing a wavelength of 808 nm, a power output of 100 mW, a dose of 2 Joules, and a fluence of 35 J/cm\^2. The laser will be positioned perpendicular to the tooth surface, targeting the cervical third of the buccal surface (both mesial and distal aspects), as well as the center of the lesion.
Eligibility Criteria
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Inclusion Criteria
* Teeth diagnosed with MIH, exhibiting at least one erupted permanent molar with the occlusal surface devoid of gingival tissue and showing sensitivity associated with MIH with sensitivity score ≤3 on the Visual Analogue Scale (VAS) and score ≤1 on the Self-Consensus Assessment scale symptoms and signs (SCASS).
* Children who have the cognitive ability to answer the tests.
* Children who obtained authorization from their parents or guardians, through a signed free and informed consent form.
Exclusion Criteria
* Teeth with other enamel defects, such as fluorosis, enamel hypoplasia, amelogenesis imperfecta or enamel malformations associated with syndromes, as well as those undergoing orthodontic treatment.
* Patients with cognitive impairments that prevent responsiveness to the test.
* Children who have undergone desensitizing treatment in the last 3 months.
* Children who use anti-inflammatory and/or analgesic medications before starting treatment.
* Teeth that have a sensitivity score \>3 on the visual analogue scale (VAS) and a score \>1 on the Schiff Cold Air Sensitivity Scale (SCASS).
6 Years
12 Years
ALL
Yes
Sponsors
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University of Sao Paulo
OTHER
Responsible Party
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Lucas Masaru Marubayashi
Clinical Professor
Locations
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Lucas Masaru Marubayashi
Ribeirão Preto, São Paulo, Brazil
Countries
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References
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Muniz RSC, Carvalho CN, Aranha ACC, Dias FMCS, Ferreira MC. Efficacy of low-level laser therapy associated with fluoride therapy for the desensitisation of molar-incisor hypomineralisation: Randomised clinical trial. Int J Paediatr Dent. 2020 May;30(3):323-333. doi: 10.1111/ipd.12602. Epub 2019 Dec 23.
Provided Documents
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Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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FORP-USP
Identifier Type: OTHER
Identifier Source: secondary_id
63035222.3.0000.5419
Identifier Type: -
Identifier Source: org_study_id
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