Evaluation of program in oral health education in children and adolescents with chronic kidney disease

Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2018
INTERVENTION: G17.035.250 I02.233.332.374 Procedure/surgery The oral health education program will be developed to treat patients with CKD and programmed to be performed using a humanoid robot (intervention group) and a dentist (control group) with a traditional approach. The 120 (n = 120) selected patients will be allocated randomly into two groups: Group 1 (G1): oral health education program to be administered by a dental surgeon (n = 60); Group 2 (G2): oral health education program that will be taught by a humanoid robot (n = 60). Before contacting the oral health education program, an evaluation form will be completed with patient data for the collection of sociodemographic data. Peds QL® 4.0 ‐ (Health related quality of life questionnaire) ‐ child / adolescent report and Peds® QL ‐ Quality of Life Questionnaire will be applied (a trained and previously calibrated evaluator for the intonation of the issues) related to oral health) ‐ child / adolescent report. Patients will undergo a clinical evaluation by a dentist trained and calibrated for the examinations, when dental evaluations will be performed. The dental surgeon will be blind to which oral health education program the patient will be allocated. Dental evaluations Gingival index (GI) It is an index by means of identifying the presence of gingival bleeding to reflect the presence of gingivitis. Assessments of gingival conditions of participants will be performed using the mm‐periodontal probe (Hu‐Friedy Colorvue® PerioScreen® probe, Chicago, IL, USA). Will the scores be recorded according to the Gingival Index in four categories? (0) = without inflammation; (1) = mild inflammation, no bleeding when probing, slight color change and texture; (2) = moderate inflammation, with flushing, edema and bleeding probing; (3) = severe inflammation, severe redness, edema, ulcerations in tissues prone to spontaneous bleeding. The periodontal probe will pass gently on the buccal and lingual surfaces of 6 deciduous teeth: 55 (vestibular), 65 (vestibular), 61 (vestib CONDITION: C05.116.198.816.750 Mineral and Bone Disorders in Chronic Kidney Disease ; C05.116.198.816.750 SECONDARY OUTCOME: secondary outcomes are not expected. INCLUSION CRITERIA: Children and adolescents aged 6 ‐18 years; cooperators in relation to the initial clinical examination and understanding of the questions and orientations presented; with possibility of follow‐up for 1 month. PRIMARY OUTCOME: Primary outcome is the prevalence of gingival inflammation. We expect an improvement in gingival inflammation after implementation of the oral health education program in children and adolescents with chronic kidney disease. The method to verify the expected outcome will be a clinical dental assessment using the gingival index using periodontal probe to see the degree of gingival inflammation. The parameters will be: 0.1 ‐ 1: mild gingivitis; 1.1 ‐ 2: moderate gingivitis; 2.1 ‐ 3: severe gingivitis.; The prevalence of gingival inflammation was based on work done in 2016 with the same population that found a prevalence of 89%. For the calculation, alfa= 5% (0.05), beta=20% (0.2) with a minimum significant difference = 1 and a standard deviation = 1.0 was considered. This gave us an estimate of 120 children and adolescents with disease renal disease.
Epistemonikos ID: 940d8d13c82be8dbdb10a47170b75eee9eac4316
First added on: Aug 24, 2024