Minimally invasive restorations in patients with intellectual disabilities

INTERVENTION: The study will be a randomized, prospective, parallel, double‐blind clinical trial (patient and evaluator), previously submitted to the Research Ethics Committee of the School of Dentistry of São Paulo State University “Júlio de Mesquita Filho” (FOA‐UNESP), with its initiation planned after approval. The parents or legal guardians of the patients will receive the research information letter, the statement of awareness and consent to participate in the research, and the informed consent form. The patients included in this study will be recruited from the Center for Dental Care for People with Disabilities (CAOE), an Auxiliary Unit of Comple XStructure of the School of Dentistry, Araçatuba Campus (FOA), São Paulo State University “Júlio de Mesquita Filho” (UNESP).Patients with intellectual disabilities, aged 6 to 20 years, who present at least one active carious lesion, Class I or Class II (ICDAS – International Caries Detection and Assessment System codes 3 to 6), in permanent teeth, with good periodontal health and no clinical history of allergy to dental products, will be eligible for participation. The exclusion criteria will be patients diagnosed with pulp exposure, fistula, pain, undergoing orthodontic treatment, or with endodontically treated teeth. Two minimally invasive techniques will be used by two calibrated operators. Thirty posterior teeth will be allocated to the control group and treated using the atraumatic restorative treatment (ART) technique with a hybrid glass ionomer cement (EQUIA Forte Fil, GC, Tokyo, Japan), followed by the application of a nanoparticulate surface coating (EQUIA Forte Coat, GC, Tokyo, Japan). Another 30 posterior teeth will be allocated to the test group and restored using an adhesive system (FL Bond II, Shofu, Kyoto, Japan) and a bulk‐fill composite resin (Beautiful Bulk Restorative, Shofu, Kyoto, Japan), resulting in a total of 60 restorations. Two calibrated operators with clinical experience, trained by faculty members specialized in restorative dentistry and dental care for patients with special needs, will perform the restorative procedures. Prior to the clinical procedures, they will undergo laboratory training consisting of theoretical and practical instruction on carious tissue removal techniques using the necessary instruments, as well as training in the restorative techniques according to the manufacturers' recommendations for the materials used, in order to standardize the operative procedures. Thirty typodont teeth will be used and proportionally divided between both protocols. The two minimally invasive techniques will be randomly assigned to each tooth using stratified randomization. Tooth type (premolar and molar) and cavity classification (Class I and Class II) will be used as stratification variables during the randomization process to minimize selection bias. The teeth will be considered the experimental units, and those eligible for inclusion will be recorded in an Excel® spreadsheet (Microsoft Office 2020) according to tooth type and cavity classification. To ensure a homogeneous CONDITION: C10.597.606.360 Dental Caries ; intellectual disabilities PRIMARY OUTCOME: We will evaluate the survival of restorations performed with different restorative materials in patients with intellectual disabilities using the Kaplan–Meier survival curve. All tests will be performed at a significance level of 5% (a = 0.05). SECONDARY OUTCOME: Comparisons between the techniques will be assessed using Fisher’s exact test. Comparisons between the evaluation periods will be analyzed using McNemar’s test. All tests will be performed at a significance level of 5% (a = 0.05). INCLUSION CRITERIA: Patients included in this study will belong to the Dental Care Center for People with Disabilities (CAOE), a Comple XStructure Auxiliary Unit of the School of Dentistry at the Araçatuba campus (FOA) of São Paulo State University “Júlio de Mesquita Filho” (UNESP); patients with intellectual disabilities; aged 6 to 20 years; who, upon clinical examination, present at least one active carious lesion, Class I or Class II (ICDAS – International Caries Detection and Assessment System codes 3 to 6) in permanent teeth; with good periodontal health and no clinical history of allergy to dental products