Photobiomodulation and New Restorative Material for Teeth With MIH on Control of Hypersensitivity and Longevity

Официальное название

Assessment of Photobiomodulation Combined With New Restorative Material for Teeth With Molar Incisor Hypomineralization on Control of Hypersensitivity and Longevity of Restorations: Randomized Controlled Blind Clinical Trial

Обзор

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 (primary outcome). Secondary outcomes include assessing the clinical performance of the self-cure composite resin in terms of restoration longevity and comparing the effectiveness of three interventions-photobiomodulation combined with self-cure resin, self-cure resin alone, and photobiomodulation combined with bulkfill photopolymerizable resin-in controlling hypersensitivity over time. 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. Data normality will be checked using the Shapiro-Wilk test, and variance homogeneity will be assessed with the Levene test. Descriptive statistics will be used to present the data, with continuous variables expressed as mean and standard deviation, and categorical variables by relative frequency. To compare the VAS and SCASS scales, repeated measures ANOVA will be employed, considering the 3 groups and 5 time points. Bonferroni adjustment will be applied for post-hoc comparisons. Sphericity will be tested with Mauchly's test, and if violated, Greenhouse-Geisser correction will be applied. A significance level of 0.05 will be adopted. Ethics and dissemination: This protocol received approval from the Human Research Ethics Committee of Nove de Julho University (certificate number: xxxxxxx). The legal guardians of the children will agree to participation by signing a statement of informed consent. The results will be published in a peer-review journal and the data will be made available upon request.

Вмешательства

• Процедура Photobiomodulation + Restoration with Self-cure Composite Resin
  1. Initial periapical radiograph; 2. Hypersensitivity reading (visual analogue scale for subjective pain of volunteer and SCASS for examiner's assessment); 3. Application of photobiomodulation; 4. Relative isolation (lip bumper, cotton roll and aspirator); 5. Selective removal of carious tissue with curette (only Code 6 of MIH-SSS criteria); 6. Cleaning with cotton and water; 7. Application of primer (Stela; SDI, Melbourne, Vic, Australia) on dentin and/or enamel, wait 5 seconds; 8. Application
• Процедура Restoration with Self-cure Composite Resin
  1. Initial periapical radiograph; 2. Hypersensitivity reading (visual analogue scale for subjective pain of volunteer and SCASS for examiner's assessment); 3. Relative isolation (lip bumper, cotton roll and aspirator); 4. Selective removal of carious tissue with curette (only Code 6 of MIH-SSS criteria); 5. Cleaning with cotton and water; 6. Application of primer (Stela; SDI, Melbourne, Vic, Australia) on dentin and/or enamel, wait 5 seconds; 7. Application of mild compressed air on adhesive for
• Процедура Photobiomodulation + Restoration with Photopolymerizable Bulk-fill Composite Resin
  1. Initial periapical radiograph; 2. Hypersensitivity reading (visual analogue scale for subjective pain of volunteer and SCASS for examiner's assessment; 3. Relative isolation; 4. Application of photobiomodulation; 5. Selective removal of carious tissue with curette (only Code 6 of MIH-SSS criteria); 6. Selective etching of enamel adjacent to demarcated opacities with 35% phosphoric acid for 20s; 7. Active application of universal adhesive (Ambar) on dentin and enamel for 20 seconds (repeat pro

Первичные конечные точки

• Hypersensitivity Assessment [Срок оценки: Prior to the procedure, 48 hours after restorative treatment and at four-month intervals for the 12-month follow-up period.]

Вторичные конечные точки (1)

• Clinical Assessment [Срок оценки: Clinical follow up after 48 hours and at four-month intervals for a period of 12 months]

Критерии участия

Критерии включения

• Male and female children;
• Eight to 12 years of age;
• At least one permanent first molar with MIH (codes 5 and 6 of molar-incisor hypomineralization severity scoring system \[MIH-SSS\])
• Presence of hypersensitivity
• Direct viewing and access.

Критерии исключения

• Clinically: signs or symptoms of pulp involvement;
• Radiographically: evidence of pulp involvement (initial periapical radiograph);
• Teeth with MIH with no indication for direct restorative treatment (multiple surfaces associated with large extensions);
• Partially erupted teeth;
• Previous restorative treatment.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Ribeiro CDPV, Mandetta ARH, Pernomiam FC, Camargo CCB, Romano IMF, Sobral APT, Leal ML, Mesquita-Ferrari RA, Fernandes KPS, Horliana ACRT, Motta LJ, Duran CCG, Bussadori SK. Assessment of photobiomodulation combined with new restorative material for teeth with molar incisor hypomineralization on control of hypersensitivity and longevity of restorations: Protocol for a randomized controlled blind c PMID 40802785

Идентификаторы

NCT: NCT06538142 · NewRestorativeMaterial

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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