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

U

University of Nove de Julho

Status and phase

Completed
Phase 2
Phase 1

Conditions

Hypomineralization Molar Incisor

Treatments

Radiation: Photobiomodulation
Procedure: Simulated Laser Therapy
Other: Use of fluoride toothpaste
Procedure: Sealant application

Study type

Interventional

Funder types

Other

Identifiers

NCT05370417
PBMDHMI

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

6 to 12 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy individuals (ASA I);
  • Children aged 6 to 12 years with at least one permanent first molar affected by MIH grades 3 and 4 (a and b) according to the MIH Treatment Needs Index (TNI), and with hypersensitivity score 2 or higher on the visual analog scale (VAS);
  • Molars with fractures and without pulp involvement or active caries;
  • Molars with eruption of the entire occlusal surface and at least one-third of the vestibular surface.

Exclusion criteria

  • Molars with hypersensitivity caused by carious lesions were excluded to avoid diagnostic confusion with pulpitis;
  • Teeth that had undergone desensitizing treatments in the previous three months, except for daily use toothpaste;
  • Those with fixed orthodontic appliances; Patients who experienced discomfort during the hypersensitivity test, or those unable to tolerate the procedure were also excluded.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

Control Group
Sham Comparator group
Description:
Participants in this group received toothpaste with fluoride concentration ≥ 1000 ppm (Parts Per Million), glass ionomer sealant and simulated low-level laser.
Treatment:
Procedure: Sealant application
Other: Use of fluoride toothpaste
Procedure: Simulated Laser Therapy
Study Group
Active Comparator group
Description:
Participants in this group received toothpaste with fluoride concentration ≥ 1000 ppm (Parts Per Million), glass ionomer sealant and active low-level laser.
Treatment:
Procedure: Sealant application
Other: Use of fluoride toothpaste
Radiation: Photobiomodulation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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