Category
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Primary study
Registry of Trials»Brazilian Registry of Clinical Trials
Year
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2020
INTERVENTION: Device Group 1 (Control Group) ‐ 13 patients will be submitted to 3 dental whitening sessions, with an interval of 7 days between sessions. At the beginning and at the end of each session, the patient will be submitted to intraoral photographs to register the color of the teeth, as well as they will be submitted to the use of the digital spectrophotometer (EasyShade ‐ Vita) to measure the color of the 6 upper anterior teeth, using a transparent silicone matrix is ??used to allow measurement at the same location of the tooth. Before starting the procedure, the patient will be dressed in Personal Protective Equipment (goggles / cap and apron), dental prophylaxis will be performed with pumice paste and water, washing the dental surface with water and applying a gingival barrier (Top Dam ‐ FGM) and photoactivation for 30 seconds with a light curing device (Raddi ‐ SDI). In this group, only the bleaching gel with 35% hydrogen peroxide (Whiteness HP ‐ FGM), with an applicator brush, will be used on the buccal surface of the upper and lower teeth, for a period of 45 minutes, with the gel changing every 15 minutes. , totaling two exchanges of the same. At the end of the established time, the excess of the whitening gel (aspiration cannula) will be aspirated and the dental surface washed with water (triple syringe), removing the gingival barrier. The patient will receive oral hygiene guidelines. Group 2 (intervention) ‐ 13 patients will be submitted to 3 dental whitening sessions, with an interval of 7 days between sessions. At the beginning and at the end of each session, the patient will be submitted to intraoral photographs to register the color of the teeth, as well as they will be submitted to the use of the digital spectrophotometer (EasyShade ‐ Vita) to measure the color Light Tooth Bleaching CONDITION: Tooth Bleaching Tooth Bleaching ; Tooth Bleaching PRIMARY OUTCOME: ‐Expected outcome: The primary outcome to be observed is the effectiveness of tooth whitening; ‐ Outcome analysis method: through objective analysis in a digital spectrophotometer (Easy Shade ‐ Vita), in which the tooth color variation can be quantified on the CIEL * a * b scale, as well as by the value information referring to the scale Vita, also measured by the same device. This scale provides an assessment of tooth color variation. The teeth analyzed for this parameter will be the 6 upper anterior teeth. A plaster model of the upper dental arch was obtained and, from this, a silicone plate was made in a vacuum machine. A hole was made in the vestibular face, corresponding to the middle third of the canine to canine, in order to have a standardization in the color measurement. This variable was evaluated by an examiner, previously calibrated, using the spectrophotometer (VITA EasyShade®, VITA Zahnfabrik, Germany); ; ‐ Parameters analyzed: To standardize the evaluation of tooth color, only the upper anterior teeth were evaluated, for which an average was determined. The color variation was determined in two ways: 1) Color variation on the Vita scale, where by obtaining the color from the Vita scale, on the spectrophotometer, where a numerical value is assigned to the hue and saturation of the tooth (B1 = 1; A1 = 2; B2 = 3; D2 = 4; A2 = 5; C1 = 6; C2 = 7; D4 = 8; A3 = 9; D3 = 10; B3 = 11; A3.5 = 12; B4 = 13; C3 = 14; A4 = 15; C4 = 16) 2) Through the color decomposition by the CIEL * ab system, calculating the variations of the axes L * (?L *), a * (?a *), b ( ?b *) and the total color difference (?E = [(?L *) 2 + (?a *) 2 + (?b *) 2] 1/2) For both evaluations, the times were used: baseline, immediately after the last session, 7 days and 1 month For each of the evaluation times, the color variation was carried out, always comparing with the baseline. SECONDARY OUTCOME: ‐Expected outcome: Another expected secondary outcome is assessment of the patient's level of satisfaction with the bleaching techniques employed. ; ; ‐ Outcome analysis method: Individuals, at the end of treatment, will provide data on the level of satisfaction with the whitening technique used, in a specific form, which covers four topics: time spent in the session, comfort of the technique, number of sessions and final result of the bleaching procedure. ; ; ‐ Parameters analyzed: For each item of the satisfaction questionnaire, the answers attributed could be: very satisfied, very dissatisfied, indifferent, satisfied and very satisfied. The analysis carried out was through the sum by group of the concept attributed to each technique. ‐Expected outcome: The expected secondary outcome is tooth sensitivity after tooth whitening. ; ‐ Outcome analysis method: Dental sensitivity will be analyzed using a visual analog scale in which the patient will identify the perception of pain, ranging from none (0), mild (1), moderate (2), considerable (3) and severe (4), in the interval: during whitening sessions and at times 24 and 48h, after the whitening procedure. ; ; ‐ Parameters analyzed: variation of the grade assigned on the visual analog scale (VAS). INCLUSION CRITERIA: Both gender; Aged between 18 and 35 years old; Who have good overall and oral health; Caries‐free upper anterior teeth; Absence of cervical lesions; Absence of restorations on the buccal surface; Periodontal health must be preserved; Center incisors should be C2 or darker according to a value oriented color scale (Vita Lumin, Vita Zahnfabrik, Bad Säckingen, Germany)
Epistemonikos ID: 33923f40e113e3bb15d6183550de3467853ff694
First added on: Aug 24, 2024