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

NCT05370417 | Completed Phase 1

• 1 other identifier: PBMDHMI
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypomineralization Molar Incisor

Outcome Measures

Primary Outcomes (2)

• Changes in pain - Visual analog scale (VAS)

  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.

  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.

Secondary Outcomes (2)

• Changes in the Simplified Oral Hygiene Index (Greene and Vermillion)

  Baseline, 48 hours after the procedures and 1 month after.

• Sealant Assessment System

  Baseline, 48 hours after the procedures and 1 month after.

Study Arms (2)

Control Group

SHAM COMPARATOR

Participants in this group received toothpaste with fluoride concentration ≥ 1000 ppm (Parts Per Million), glass ionomer sealant and simulated low-level laser.

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

Study Group

ACTIVE COMPARATOR

Participants in this group received toothpaste with fluoride concentration ≥ 1000 ppm (Parts Per Million), glass ionomer sealant and active low-level laser.

Other: Use of fluoride toothpaste; Radiation: Photobiomodulation; Procedure: Sealant application

Interventions

Use of fluoride toothpaste OTHER

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.

Control Group; Study Group

Photobiomodulation RADIATION

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.

Study Group

Simulated Laser Therapy PROCEDURE

The same application described in the laser therapy group will be simulated, with the device turned off.

Control Group

Sealant application PROCEDURE

A glass ionomer sealant will be applied to the occlusal surface of the first permanent molar.

Control Group; Study Group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Sandra Bussadori

São Paulo, São Paulo, 01504-001, Brazil

Location

Related Publications (2)

• Fossati AL, Mandetta ARH, Sobral APT, Bruno LH, Viarengo NO, Sertaje MRF, Santos EM, Goncalves MLL, Mesquita-Ferrari RA, Fernandes KPS, Horliana ACRT, Motta LJ, Deana AM, Dos Santos-Pinto LAM, Bussadori SK. Randomized clinical trial of photobiomodulation and glass ionomer sealant for hypersensitivity in molar incisor hypomineralization. Sci Rep. 2025 Aug 29;15(1):31911. doi: 10.1038/s41598-025-17454-8.

  PMID: 40883469 DERIVED

• Fossati AL, Sobral APT, Hermida Bruno MLL, Viarengo NO, Sertaje MRF, Santos EM, Goncalves MLL, Ferrari RAM, Fernandes KPS, Horliana ACRT, Motta LJ, Bussadori SK. Photobiomodulation and glass ionomer sealant as complementary treatment for hypersensitivity in molar incisor hypomineralisation in children: protocol for a blinded randomised clinical trial. BMJ Open. 2023 Jun 14;13(6):e068102. doi: 10.1136/bmjopen-2022-068102.

  PMID: 37316315 DERIVED

MeSH Terms

Conditions

Molar Hypomineralization

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The application of low-intensity laser will be simulated in one of the groups, to maintain the study blind.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 11, 2022
• Study Start: July 19, 2022
• Primary Completion: March 20, 2023
• Study Completion: March 12, 2024
• Last Updated: October 3, 2024

Record last verified: 2024-10

Locations

BR (1)