Effect on Oral Health, Phycosocial Impact and Esthetics Perception of Bleaching Teeth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Oral Health and quality of Life
研究概览
简要总结
58 patients between 18 and 76 years who attended the Operative Dentistry Clinic at Dental School, Universidad de Chile, were included in the study. Those patients were bleaching and included in this study and signed a consent form. The patients were treated with 10% carbamide peroxide (CP) gel (Whiteness Perfect, FGM) to each subject with verbal instructions for 3 weeks with daily applications of 1 hour according to manufacturers indications , before and after this procedure was applied again the OHIP-Esthetics , PIDAQ and OES questionnaire form, had 30 minutes to answer it, were completed before , immediately after and one month control post-bleaching procedure.
详细描述
This study was approved by the Ethics Committee of the Faculty of Dentistry (13/18a). This study included 58 patients aged between 18 and 76 years who attended the Operative Dentistry Clinic at the Dental School from the Local University and were eligible for bleaching (see eligibility criteria in the next item). Dental bleaching, free of charge, was suggested to the patients as a way to improve the patient's smile. The patients were informed about the benefits and possible side effects of the procedure in a standardized manner.
Eligibility criteria for dental bleaching Participants were evaluated in a dental chair and after prophylactic dental treatment with pumice and water. To be eligible for dental bleaching, participants should have good general and oral health. Each subject should have at least one central incisor shaded A2 or darker, assessed by comparison with a value-oriented shade guide (Vita classical; Vita Zahnfabrik, Bad Säckingen, Germany). Patients who had undergone previous dental bleaching procedures, under orthodontic treatment, who were pregnant or lactating, or who had bruxism habits were not eligible for dental bleaching. Participants with restorations on the labial surfaces of their anterior teeth, non-carious cervical lesions, veneers, full crowns, gingival recession, spontaneous tooth pain, internal tooth discoloration, and teeth with endodontic treatment or fluorosis were also not included as they could not be immediately eligible for dental bleaching.
Bleaching Procedure For the participants who were bleaching procedure, we made alginate impressions of each subject's maxillary and mandibular arches, and these were filled with dental stone. We did not apply block-out material to the labial surfaces. A 1-mm soft vinyl material, provided by the manufacturer (FGM Dental Products, Joinville, SC, Brazil) was used to fabricate the custom-fitted tray to hold the bleaching gel. The bleaching tray was trimmed 1 mm beyond the marginal gingiva and we delivered a 10% carbamide peroxide (CP) gel (Whiteness Perfect, FGM) to each participant. We give them verbal instructions to apply the product 1 hour daily for 3 weeks. After each application, the patient should remove the tray, wash it with water, and brush teeth as usual. Verbal instructions for oral hygiene were also given, encouraging regular brushing with fluoridated toothpastes that did not contain whitening components.
For these participants, the OHIP-Esthetics, PIDAQ and OES surveys were applied before , one week and one month after the end of the bleaching procedure, and the patient was also given 30 minutes to complete it.
Color Evaluation Color evaluations were performed using subjective and objective methods. For the subjective evaluation, the 16 tabs of the Vita shade Classical guide Vita classical (Vita Zahnfabrik, Bad Säckingen, Germany) were arranged from highest (B1) to lowest (C4) value and used to determine tooth color. Although this scale is not linear in the truest sense, it was treated as continuous with a linear ranking. Two calibrated evaluators with an agreement of at least 85% (using weighted kappa statistics) recorded the shade of the middle area of the labial surface of the upper central right incisor according to the American Dental Association guidelines. Color was registered at baseline and during treatment (after the first, second, and third week of bleaching), and one week and one month after the end of the bleaching protocol to corroborate the effectiveness of bleaching procedure. The color change between baseline and each recall time was calculated as the change in the number of shade guide units (ΔSGU), which occurred toward the lightest end of the value-oriented list of shade tabs. In case the operators disagreed on the color, a consensus was reached before dismissing the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy patients with Anterior teeth without restorations, previous bleaching procedures, cervical lesions, or dental pain
排除标准
- •Pregnant or lactating,
- •Had moderate or severe fluorosis,
- •Tetracycline stains,
- •Orthodontic treatment,
- •Periodontal disease,
- •Orofacial tumors,
- •Tooth malformation Were taking analgesic, anti-inflammatory, or antibiotic drugs
研究组 & 干预措施
bleaching teeth
Group of patients will be bleaching with 10% peroxide carbamide , and them will be assessed the impact on dental confidence , impact psychosocial and esthetic perception
干预措施: Bleaching teeth (Drug)
结局指标
主要结局
Oral Health and quality of Life
时间窗: 1 month
Assesed by OHIP-Esthetics survey
次要结局
- phycosocial impact(1 month)
- esthetics perception(1 month)
研究者
Eduardo Fernandez
Prof. Dr. Eduardo Fernández
University of Chile
