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.

Abstract

Introduction: Photobiomodulation has been widely used as a complementary treatment for dentin hypersensitivity, with reports of clinical success. However, the literature offers only one study, in which photobiomodulation was used for the treatment of sensitivity in molars with molar incisor hypomineralisation (MIH). The aim of the proposed study is to determine whether photobiomodulation enhances the results of treatment with glass ionomer sealant on molars with MIH that present sensitivity.

Methods and analysis: The study involves 50 patients from 6 to 12 years of age that will be randomly allocated in two groups. Group 1 (control group) (n=25): toothpaste with a concentration of fluoride ≤1000 ppm two times a day, glass ionomer sealant and sham low-level laser (LLL) and group 2 (n=25): toothpaste with a concentration of fluoride ≤1000 ppm two times a day, glass ionomer sealant and active LLL. The evaluations will involve MIH record, Simplified Oral Hygiene Index (OHI), Schiff Cold Air Sensitivity Scale (SCASS) and visual analogue scale (VAS) before the procedure. Immediately after the procedure, the hypersensitivity index (SCASS/VAS) will be registered. Records of OHI and SCASS/VAS will be registered after 48 hours as well as 1 month after the procedure. The persistence of the sealant will also be registered. It is expected that by the second consultation, a decrease in sensitivity will be observed due to the treatments received in the two groups.

Ethics and dissemination: This protocol has been approved by the local medical ethical committee (certificate: CEUCU 220516). The findings will be published in a peer-reviewed journal.

Trial registration number: NCT05370417.

Keywords: COMPLEMENTARY MEDICINE; Laser therapy; PAEDIATRICS; PAIN MANAGEMENT.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Child
  • Fluorides* / therapeutic use
  • Humans
  • Molar Hypomineralization*
  • Randomized Controlled Trials as Topic
  • Research Design
  • Toothpastes / therapeutic use

Substances

  • Fluorides
  • glass ionomer
  • Toothpastes

Associated data

  • ClinicalTrials.gov/NCT05370417