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临床试验/NCT05605834
NCT05605834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 University1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2023年1月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
1
主要终点
Peroxide level in saliva

研究概览

简要总结

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

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. Several researches have focused on the problem of gel ingestion and potential peroxide release in saliva

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. 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. 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. 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 . 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
Double (Participant, 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
是

入选标准

  • •participants:
  • •Good general health.
  • •Adult patients aged 18-40 years.
  • •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

  • •participants:
  • •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.

研究组 & 干预措施

Hydrogen peroxide 9.5% bleaching using a tray with reservoir.

Experimental

9.5% hydrogen peroxide bleaching (POLA DAY advanced tooth whitening system, SDI) using a tray with reservoir.

干预措施: 9.5% hydrogen peroxide bleaching (POLA DAY advanced tooth whitening system, SDI) using a tray with reservoir (Other)

Hydrogen peroxide 9.5% bleaching using a tray without reservoir.

Active Comparator

9.5% hydrogen peroxide bleaching (POLA DAY advanced tooth whitening system, SDI) using a tray without reservoir.

干预措施: 9.5% hydrogen peroxide bleaching (POLA DAY advanced tooth whitening system, SDI) using a tray without reservoir. (Other)

结局指标

主要结局

Peroxide level in saliva

时间窗: T3: 30 min after tray application

Peroxide concentration in saliva (mg/ml)

Peroxide level in saliva

时间窗: T0: 1 min after beginning of the bleaching procedure and application of the tray

Peroxide concentration in saliva (mg/ml)

Peroxide level in saliva

时间窗: T1: 5 min after tray application

Peroxide concentration in saliva (mg/ml)

Peroxide level in saliva

时间窗: T2: 10 min after tray application

Peroxide concentration in saliva (mg/ml)

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

bachelor

Cairo University

研究点 (1)

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