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临床试验/NCT05612516
NCT05612516已完成不适用

Assessment of Peroxide Level in Saliva During Teeth Bleaching With 9.5% Hydrogen Peroxide Gel Using a Tray With Reservoir Versus a Tray Without Reservoir. A Randomized Clinical Trial

Cairo University2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2024年1月10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
34
试验地点
2
主要终点
Hydrogen peroxide level in saliva

研究概览

简要总结

The aim of the study is to clinically assess the peroxide levels in saliva during bleaching with 9.5% hydrogen peroxide using a tray with or without reservoir.

详细描述

Statement of the Problem There is more concern about the possible adverse effect of bleaching agent, patients report gastrointestinal mucosal irritation e.g. a burning palate, throat and minor upsets in the stomach and intestine. Some adverse effects of hydrogen peroxide as a dental bleaching agent include dentin sensitivity and/or gingival irritation led by unstable and reactive H+ free radicals and low pH from prolonged use. Peroxide is a highly reactive substance which can damage oral soft tissues and hard tissues when present in high concentrations and with exposures of prolonged duration. (Alqahtani, 2014). Several researches have focused on the problem of gel ingestion and potential peroxide release in saliva (Dahl et al, 2003; Watt et al, 2004; Bernardon et al, 2010; Goldberg et al, 2010).

Rationale

Reservoirs are modifications in the tray molds to increase the amount of bleaching material carried by the bleaching tray, seeking greater bleaching efficacy. The use of reservoirs in the bleaching trays was initially seen as positive, since higher accumulation of material could provide the patient with greater treatment efficacy. Martini et al, 2020 stated that there is no significant difference between groups whitened with and without reservoirs for gingival irritation or tooth sensitivity. Most authors and bleaching gel manufacturers recommend the use of reservoirs to increase the amount of product available for bleaching and to allow for complete seating of the bleaching tray, although that the reservoirs decrease tray retention and increase lab fabrication time and cost (Javaheri et al, 2000). The presence of reservoirs decreases the retention of the tray, allowing more room for the gel but also reducing the adaptation of the tray. That may cause more leakage of the material, which may lead to more peroxide level in saliva. (Haywood et al, 1992).

A major concern for clinicians was the potential toxicological effect of hydrogen peroxide contacting soft tissues. A safe hydrogen peroxide exposure level (no observed effect level) was determined with catalase-deficient mice, reporting a maximum dose of 26 mg/kg/d. This corresponds to the dose level in humans, considering the conventional uncertainty factor of 100-fold, of 0.26 mg/kg/d (IGHRC, 2003; Hannig et al, 2005; Li et al, 2011). The safety of hydrogen peroxide products used for at home bleaching regarding peroxide release in saliva has not been fully proven.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Good general health.
  • Absence of non-carious cervical lesions, active caries, gingival recession, or periodontal disease.
  • Do not use orthodontics appliance or removable prosthesis.
  • Maxillary anterior teeth without caries, restorations and/or endodontic treatment.
  • Mild generalized staining.

排除标准

  • Smoking or alcohol dependent patients.
  • Pregnancy and lactating women.
  • Parafunctional habits or pathologies.
  • Periapical alterations.
  • Use of medicaments that alter salivary flow.
  • Patients who had already undergone tooth bleaching
  • Patients with severe internal tooth discoloration as tetracycline stain, fluorosis or endodontic treatment.
  • Tooth hypersensitivity.
  • Presence of cracks or fractures.
  • Periodontal affection sign and symptoms.

结局指标

主要结局

Hydrogen peroxide level in saliva

时间窗: T3: 30 min after tray application

A spectrophotometry method based on the reaction of 4-aminoantipyrine and phenol with hydrogen peroxide will be adopted. This method will allow the oxidation of peroxide by peroxidase enzyme, resulting in solution color change from transparent to pink. The amount of hydrogen peroxide in saliva will be quantified by an analytic spectrophotometer, which will relate light absorbance with peroxide concentration of each sample.

次要结局

未报告次要终点

研究者

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

Anas Yousef Mohammad

Master Degree student- Faculty of Dentistry

Cairo University

研究点 (2)

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