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

Phase 1
Completed
Conditions
Hypomineralization Molar Incisor
Interventions
Other: Use of fluoride toothpaste
Procedure: Simulated Laser Therapy
Radiation: Photobiomodulation
Procedure: Sealant application
Registration Number
NCT05370417
Lead Sponsor
University of Nove de Julho
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
50
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Control GroupUse of fluoride toothpasteParticipants in this group received toothpaste with fluoride concentration ≥ 1000 ppm (Parts Per Million), glass ionomer sealant and simulated low-level laser.
Control GroupSimulated Laser TherapyParticipants in this group received toothpaste with fluoride concentration ≥ 1000 ppm (Parts Per Million), glass ionomer sealant and simulated low-level laser.
Control GroupSealant applicationParticipants in this group received toothpaste with fluoride concentration ≥ 1000 ppm (Parts Per Million), glass ionomer sealant and simulated low-level laser.
Study GroupUse of fluoride toothpasteParticipants in this group received toothpaste with fluoride concentration ≥ 1000 ppm (Parts Per Million), glass ionomer sealant and active low-level laser.
Study GroupPhotobiomodulationParticipants in this group received toothpaste with fluoride concentration ≥ 1000 ppm (Parts Per Million), glass ionomer sealant and active low-level laser.
Study GroupSealant applicationParticipants in this group received toothpaste with fluoride concentration ≥ 1000 ppm (Parts Per Million), glass ionomer sealant and active low-level laser.
Primary Outcome Measures
NameTimeMethod
Changes in pain - Visual analog scale (VAS)Baseline, 48 hours after the procedures and 1 month after.

The perception of pain in children was assessed using the Wong-Baker Faces Pain Rating Scale. This scale facilitates communication, allowing for a more accurate assessment of the pain reported by the child.

Changes in the Schiff Cold Air Sensitivity Scale (SCASS)Baseline, 48 hours after the procedures and 1 month after.

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).

Secondary Outcome Measures
NameTimeMethod
Changes in the Simplified Oral Hygiene Index (Greene and Vermillion)Baseline, 48 hours after the procedures and 1 month after.

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

Sealant Assessment SystemBaseline, 48 hours after the procedures and 1 month after.

The retention of the sealant was evaluated after 1 month using the CCC Sealant Evaluation System. For statistical purposes, the following classification was considered: A: sealant present; B: Sealant present on 50% of fissure pattern but some missing; C: Sealant present on 50% of fissure pattern.; D: no sealant present.

Trial Locations

Locations (1)

Sandra Bussadori

🇧🇷

São Paulo, SP, Brazil

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