Photobiomodulation and New Restorative Material for Teeth With MIH on Control of Hypersensitivity and Longevity
NCT Number: NCT06538142
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hypomineralization Molar Incisor|Hypersensitivity Dentin
Interventions: PROCEDURE: Photobiomodulation + Restoration with Self-cure Composite Resin|PROCEDURE: Restoration with Self-cure Composite Resin|PROCEDURE: Photobiomodulation + Restoration with Photopolymerizable Bulk-fill Composite Resin
Sponsor: University of Nove de Julho
Sex: ALL
Age: CHILD
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-11-01
Completion Date: 2026-09-01

Summary:
Introduction: Molar incisor hypomineralization (MIH) is a qualitative defect of enamel development that occurs in the mineralization phase. MIH affects one or more permanent molars and, occasionally, permanent incisors.

Objective: The aim of the proposed study is to determine whether photobiomodulation combined with a new self-cure resin improves hypersensitivity in molars with MIH and caries. The clinical performance of the self-cure composite resin will also be assessed through an analysis of restoration longevity.

Methods and analysis: Permanent molars with MIH in patients eight to 12 years of age will be allocated to three groups. Group 1: photobiomodulation + self-cure composite resin restoration; Group 2: self-cure composite resin restoration; Group 3: photobiomodulation + restoration in bulk-fill photopolymerizable composite resin. Photobiomodulation will be performed in a single session involving low-level laser administered to four different points. The laser will be used at a wavelength of 808 nm, power of 100 mW and energy of 1 J per points; irradiance will be 3571 mW/cm², with a total radiant exposure of 35.7 J/cm². The data will be analyzed using descriptive statistics. Associations with age and sex will be tested using either the chi-square test or Fisher's exact test. Pearson's correlation coefficients will be calculated to determine the strength of correlations between variables. Kaplan-Meier survival analysis will be performed to assess the performance of the restorations.

Primary Outcome Measures: Hypersensitivity Assessment, The Visual Analogue Scale (VAS) will be used for the subjective assessment of hypersensitivity on the part of the volunteer and the Schiff Cold Air Sensitivity Scale (SCASS) will be used for the assessment of the operator and examiner. Following isolation of the neighboring teeth with gauze, compressed air will be applied to the tooth with MIH for three seconds. The SCASS is scored as follows: 0 (no reaction); 1 (no reaction, but patient reports discomfort); 2 (patient reacts and moves away from stimulus); and 3 (patient reacts and asks operator to stop)., Prior to the procedure, 48 hours after restorative treatment and at four-month intervals for the 12-month follow-up period.
Secondary Outcome Measures: Clinical Assessment, The criteria will be the retention of the restorative material in the cavity, rupture of the enamel adjacent to the restoration and the occurrence of secondary caries. The criteria of the modified USPHS index will be used for the assessment. The restoration will be characterized as a failure and the tooth will be excluded from the study if the C score is determined for any of the USPHS criteria. Photographs of the restorations will be taken using a digital single-lens reflex (DSLR) camera (Canon EOS 700D; Canon, Tokyo, Honshu, Japan) to complement the clinical data. The visual demonstration will contribute to any necessary clarifications and make the discussion and documentation of the cases more efficient., Clinical follow up after 48 hours and at four-month intervals for a period of 12 months