Photobiomodulation and Glass Ionomer Sealant as Complementary Treatment for Hypersensitivity in Molars With MIH

Study Overview
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Brief Summary
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Photobiomodulation has been widely used as complementary treatment for dentin hypersensitivity, with reports of clinical success. However, the literature offers only one study in which photobiomodulation was used for the treatment of sensitivity in molars with molar incisor hypomineralization (MIH). The aim of the proposed study is to determine whether photobiomodulation enhances the results of treatment with glass ionomer sealant on molars with MIH that present sensitivity. Methods and analysis: The study involving 50 patients 6 to 12 years of age tha will be randomly allocated in two groups. Group 1 (control group) (n = 25): toothpaste with a concentration of fluoride, glass ionomer sealant and sham low-level laser (LLL) and Group 2 (n = 25): toothpaste with a concentration of fluoride, glass ionomer sealant and active low-level laser (LLL). The evaluations will involve MIH record, Simplified Oral Hygiene Index (OHI), Schiff Cold Air Sensitivity Scale (SCASS) and Visual analog scale (VAS) before the procedure. Immediately after the procedure hypersensitivity index (SCASS/VAS) will be register. Record of OHI and SCASS/VAS will be register 48 horas after and as well as 01 month after the procedure. It is expected that by the second consultation a decrease in sensitivity will be observed due to the treatments received in the two groups.

Official Title
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Photobiomodulation and Glass Ionomer Sealant as Complementary Treatment for Hypersensitivity in Molars With MIH in Children - Protocol for a Blinded Randomized Clinical Trial.

Conditions
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Hypomineralization Molar Incisor

Intervention / Treatment
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* Other: Use of fluoride toothpaste
* Radiation: Laser Therapy
* Procedure: Simulated Laser Therapy
* Procedure: Sealant application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a permanent molar primer with MIH; Present hypersensitivity equal to the highest 3 in the VAS Scale. Exclusion Criteria: Molars with caries activity (which can confuse the etiology of hypersensitivity with pulpitis); Desensitizing treatment during the last 3 months; Patients who use orthodontics on the first molars; Patients who, during the study, present an adverse reaction or discomfort to the hypersensitivity tests or do not tolerate the procedure will also be excluded.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Group<br>Participants in this group will receive fluoride toothpaste, simulated laser therapy and sealants. | Other: Use of fluoride toothpaste<br>* All participants will receive brushing instruction and will be provided with toothpaste with a concentration equal to or greater than 1000ppm of fluoride, indicating three daily brushings. With this generalized measure, all of them receive basic treatment for hypersensitivity.<br>Procedure: Simulated Laser Therapy<br>* The same application described in the laser therapy group will be simulated, with the device turned off.<br>Procedure: Sealant application<br>* A glass ionomer sealant will be applied to the occlusal surface of the first permanent molar.<br>|
| Active Comparator: Photobiomodulation Group<br>Participants in this group will receive fluoride toothpaste, active laser therapy and sealant simulation. | Other: Use of fluoride toothpaste<br>* All participants will receive brushing instruction and will be provided with toothpaste with a concentration equal to or greater than 1000ppm of fluoride, indicating three daily brushings. With this generalized measure, all of them receive basic treatment for hypersensitivity.<br>Radiation: Laser Therapy<br>* For laser application, the following dosimetric parameters will be used: Low level laser diode (infra red) wavelength 808nm with a power of 100mW. Applied in three perpendicular points and in contact with the surface. One in the vestibular, mesial and distal cervical third and the third in the center of the lesion. (6) Applied 10 seconds per point with an energy of 1 J.<br>Procedure: Sealant application<br>* A glass ionomer sealant will be applied to the occlusal surface of the first permanent molar.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in pain | Participants will use a Visual Analog Scale (VAS) to grade the pain they feel in the affected teeth. They will choose from zero (no pain) to ten (worst possible pain) according to the degree of discomfort they feel. | Baseline, 48 hours after the procedures and 1 month after. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in MIH record | For the determination of MIH according to the European Academy of Paediatric Dentistry, the following criteria will be considered: Tooth affected by demarcated opacity on occlusal or vestibular face. Defects may vary in shape, size and pattern. White, beige or brownish-yellow defects may be recognized. Defects may have different sizes (less than 1 mm is not registered). Presence of hypersensitivity Teeth with atypical restorations Permanent teeth suspected of having been extracted due to MIH. Combination of characteristics above. | Baseline, 48 hours after the procedures and 1 month after. | 
| Changes in the Simplified Oral Hygiene Index (Greene and Vermillion) | Analysis of soft plaque deposit: Code 0 = no deposits or pigmentation Code 1 = deposits covering less than 1/3 or presence of pigmentation Code 2 = deposits covering more than 1/3 but less than 2/3 Code 3 = deposits covering more than 2/3 of tooth surface | Baseline, 48 hours after the procedures and 1 month after. | 
| Changes in the Schiff Cold Air Sensitivity Scale (SCASS) | The (SCASS) will be used to assess subject response to this stimulus (0=no response to the stimulus; 1=no response to the stimulus, patient considers stimulus to be painful; 2= response to stimulus, patient moves from the stimulus; 3= response to the stimulus, patient moves from the stimulus and requests immediate discontinuation of the stimulus). | Baseline, 48 hours after the procedures and 1 month after. |