NCT05370417

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Nove de Julho · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Accepted

Summary

Introduction: Photobiomodulation (PBM) shows promising results for the complementary treatment of dentin hypersensitivity; however, few studies have evaluated this treatment specifically for teeth affected by molar incisor hypomineralization (MIH). The aim of this study was to assess the effects of photobiomodulation combined with glass ionomer sealant on hypersensitivity in molars with MIH. Methods: Forty-nine children six to twelve years of age with a molar affected by MIH (Grade 3, 4a or 4b) of the MIH-TNI (Treatment Needs Index) criteria were randomly allocated to two groups - Group 1 (control group) (n = 25): toothpaste with fluoride concentration ≥ 1000 ppm (Parts Per Million) twice per day, glass ionomer sealant and simulated PBM; Group 2 (study group) (n = 24): toothpaste with fluoride concentration ≥ 1000 ppm twice per day, glass ionomer sealant and active PBM. Data collection involved the record of MIH, Schiff cold air sensitivity scale (SCASS), visual analog scale (VAS), the simplified oral hygiene index (OHI) and the colour, coverage, caries (CCC) sealant evaluation system. Results: Forty-six children completed the study and were evaluated one month after the onset of treatment. A significant reduction in the Schiff Cold Air Sensitivity Scale (SCASS) was found only in the active PBM group. Reductions in Visual Analog Scale (VAS) scores were observed in both groups, with a statistically significant difference between the groups at the 48-hour and 1-month assessments following PBM application. Similarly, significant differences in the Oral Hygiene Index (OHI) were found only in the active PBM group when comparing baseline values to those after 48 hours and one month. A significant difference between the groups was noted for sealant durability at one month, with better scores in the active PBM group. Conclusion: The administration of photobiomodulation combined with glass ionomer cement improves hypersensitivity and oral hygiene in molars with MIH. The improvement in oral hygiene increases the quantity of remaining sealant on teeth with MIH.

Conditions

• Hypomineralization Molar Incisor

Interventions

Type	Name	Description
OTHER	Use of fluoride toothpaste	The participants received oral hygiene instructions - routine brushing twice per day with toothpaste containing 1000 ppm of fluoride. All participants received a toothbrush and toothpaste to ensure standardization. The aim of this intervention was to assess whether the participants' brushing technique would improve with desensitization.
RADIATION	Photobiomodulation	For laser application, the following dosimetric parameters will be used: Low level laser diode (infra red) wavelength 808nm with a power of 100mW. Three sessions: initial session, after 48 hours and after one month. LLL was applied to three perpendicular points in contact with the surface on the mesial vestibular and distal cervical faces and in the center of the occlusal face. An energy of 1 J was applied for 10 seconds at each point.
PROCEDURE	Simulated Laser Therapy	The same application described in the laser therapy group will be simulated, with the device turned off.
PROCEDURE	Sealant application	A glass ionomer sealant will be applied to the occlusal surface of the first permanent molar.

Timeline

• Start date: 2022-07-19
• Primary completion: 2023-03-20
• Completion: 2024-03-12
• First posted: 2022-05-11
• Last updated: 2024-10-03

Locations

1 site across 1 country: Brazil