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Completed

NCT Number: NCT05370417

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

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.

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Key information

Conditions

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

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Sandra Bussadori

São Paulo, 01504-001, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Simulated Laser Therapy

Procedure

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

Sealant application

Procedure

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

Primary outcomes

  1. Changes in pain - Visual analog scale (VAS)

    Time frame: 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.

  2. Changes in the Schiff Cold Air Sensitivity Scale (SCASS)

    Time frame: 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 outcomes

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

    Time frame: 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

  2. Sealant Assessment System

    Time frame: Baseline, 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.

Sponsors and collaborators

Lead sponsor

University of Nove de Julho

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
May 11, 2022
Registry last updated
Oct 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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