Clinical trial NCT05370417: Photobiomodulation and Glass Ionomer Sealant as Complementary Treatment for Hypersensitivity in Molars With MIH
Official title: Photobiomodulation and Glass Ionomer Sealant as Complementary Treatment for Hypersensitivity in Molars With MIH in Children - Protocol for a Blinded Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hypomineralization Molar Incisor
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2022-05-11
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in pain - Visual analog scale (VAS)
timeFrame: Baseline, 48 hours after the procedures and 1 month after.
measure: Changes in the Schiff Cold Air Sensitivity Scale (SCASS)
timeFrame: Baseline, 48 hours after the procedures and 1 month after.
Secondary outcomes:
measure: Changes in the Simplified Oral Hygiene Index (Greene and Vermillion)
timeFrame: Baseline, 48 hours after the procedures and 1 month after.
measure: Sealant Assessment System
timeFrame: Baseline, 48 hours after the procedures and 1 month after.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Sandra Bussadori
state: SP
Study officials:
References: