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临床试验/NCT06666920
NCT06666920已完成不适用

Evaluation of Tooth Color Change and Sensitivity Following Laser-assisted In-office Tooth Bleaching Using Er,Cr:YSGG Laser: a Split-mouth Clinical Study

Aristotle University Of Thessaloniki2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Tooth color and whiteness changes

研究概览

简要总结

The aim of this split-mouth clinical study was to evaluate the tooth color (ΔΕab and ΔΕ00) and whiteness (ΔWID) changes, as well as tooth sensitivity (TS) induced after performing in-office tooth bleaching procedure with or without light-activation of the bleaching gel using Er,Cr:YSGG laser irradiation. Twenty patients with tooth shade A3 or darker were selected for this single-blinded, split-mouth study. The bleaching session was conducted with two 20-min sessions of a 40% hydrogen peroxide bleaching agent assisted by Er,Cr:YSGG laser (2780 nm) irradiation on one side (left) of the maxillary and mandibular teeth and without laser activation on the other hemiarch (right). ΔΕab, ΔΕ00 and ΔWID were evaluated in central incisors and canines using a clinical spectrophotometer immediately, 1 week and 1 month after the bleaching procedure. TS was evaluated pre-operatively and immediately post-operatively using a visual analogue scale (VAS).

详细描述

The study description adheres to the guidelines of the Consolidated Standards of Reporting Trials (CONSORT) statement. A factorial, single-blind, split-mouth design was employed in this study, with the following factors being examined:

  1. Bleaching treatment: two treatment protocols were used, Group 1 (control) - 40% H2O2 bleaching agent and Group 2 - 40% H2O2 bleaching agent + Er,Cr:YSGG laser.
  2. Evaluation time: three time points were used for the analysis of bleaching efficacy (T1 at immediately after the treatment, T2 at 7 days after the treatment and T3 at 30 days after the treatment). All color measurements were compared with the baseline values recorded prior to the start of the bleaching treatments. Additionally, tooth sensitivity was assessed at two time points: T1, just before the treatments began, and T2, immediately after the treatments were completed. Patients and the researchers administering the bleaching treatment were not blinded, as it was not possible to conceal whether the bleaching gel was exposed to laser irradiation. However, the evaluator responsible for recording color and sensitivity remained blinded to the treatment conditions.

Bleaching procedure

The study took place at the Postgraduate Dental Clinic of the Department of Operative Dentistry of Aristotle University of Thessaloniki. Initially, twenty volunteers (11 women and 9 men) between the ages of 22 and 48 (mean age 31.1±7.0 years) were enrolled. Patient selection was based on clinical and radiographic examinations, along with a detailed medical history, all conducted prior to the bleaching treatments. Participants were informed about the study's purpose, as well as the potential risks and benefits of the experimental treatment. Those who agreed to participate signed an informed consent form and were provided with both written and verbal instructions regarding hygiene, bleaching gel application, and diet. One week before the tooth bleaching treatment a periodontal treatment using an ultrasonic scaler type Cavitron (KaVo Dental GmbH, Biberach/Riss, Germany) was carried out to remove any external stains or calculus deposits.

All patients received a conventional in-office bleaching treatment using a red-colored bleaching agent with a neutral pH, consisting of 40% H2O2 (Opalescence Boost™ PF 40%, Ultradent Products, Inc., South Jordan, UT, USA). According to the manufacturer's instructions, the contents of the two syringes were blended 25 times and applied in a layer approximately 1 mm thick on the labial surface of the anterior teeth and buccal surface of premolars. After application of a light-cured liquid dam on the gingiva, the bleaching gel was applied on the surface for 20 min, with agitation every 5 min, and subsequently removed using a surgical suction tip. This procedure was repeated for another 20 min (40 min in total) and finally a thorough rinsing with water was followed.

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 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Good overall health
  • Healthy oral tissues
  • Vital upper and lower anterior teeth
  • No carious or non-carious lesions
  • Tooth shade A3 or darker

排除标准

  • Patients with direct or indirect restorations on their upper or lower anterior teeth.
  • Patients using orthodontic appliances.
  • Patients undergone previous bleaching treatments.
  • Patients with a history of adverse reactions to peroxides.
  • Patients taking opioid medications
  • Patients having pacemakers.
  • Patients with severe tooth discoloration due to tetracycline, trauma, fluorosis, or other causes.
  • Patients with clinically verifiable dentin exposure; or those with dental sensitivity or a history of treatment for dental sensitivity.
  • Pregnant or lactating women.
  • Patients with neurological disorders.
  • Individuals taking medications that could cause photosensitivity.
  • Patients with chronic or acute diseases.

结局指标

主要结局

Tooth color and whiteness changes

时间窗: The measurements were performed at four time points: a) before the bleaching treatment (baseline), b) immediately after the bleaching treatment, c) one week after the bleaching treatment (7 days) and d) one month after the bleaching treatment (30 days).

Tooth color and whiteness changes will be evaluated using a clinical spectrophotometer. According to Commission Internationale de l'Eclairage Lab (CIELAB) color space tooth color change (ΔEab) using the CIELAB system was determined using equation (1): ΔEab = \[(ΔL)2 + (Δa)2 + (Δb)2\]1/2 (1) Moreover, tooth color change using the CIEDE2000 system, employing the h (hue) and C (chroma) values was calculated using equation (2): ΔE00 = \[(ΔL'/KLSL)2 + (ΔC'/KCSC)2 + (ΔH'/KHSH)2 + RT × (ΔC'/KCSC) × (ΔH'/KHSH)\]1/2 (2) The Whiteness Index for Dentistry (WID) was evaluated based on CIELAB parameters before and after the bleaching treatments, using equations (3) and (4): WID= 0.511L - 2.324a - 1.100b (3) ΔWID= WIDi - WID0 (4)

次要结局

  • Tooth sensitivity(Measurements were carried out before and immediately after the bleaching procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dimitrios Dionysopoulos

Assistant Professor of the Department of Operative Dentistry of Aristotle University of Thessaloniki

Aristotle University Of Thessaloniki

研究点 (2)

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