Evaluation of the Treatment of Halitosis With Photodynamic Therapy in Older Patients With Complete Denture: Protocol for a Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Halimetry (Gas Chromatography test)
研究概览
简要总结
Halitosis is the term used to define an unpleasant odor emanating from the mouth. Some lung diseases and diabetes are among the extra-oral causes of this condition. However, no studies have evaluated the causes and treatment of halitosis in the population of older adults with denture. A randomized, controlled trial is proposed. The patients will be divided into 2 groups: G1: older adults who wear complete dentures and will be treater with tongue scraper (n = 20); G2 older adults who wear complete dentures and will be treater with PDT (n = 20). If the halitosis persists, the participants will be submitted to hygiene procedures for the mucosa and dentures. The evaluation of halitosis will be repeated. If the halitosis is resolved, the participants will return after one week for an additional evaluation. This protocol will determine the effectiveness of photodynamic therapy regarding the reduction of halitosis in older adults with complete denture.
详细描述
Methods:
A single-center, randomized, controlled, single-blind clinical trial was designed in accordance with the criteria recommended for interventional trials in the SPIRIT Statement. The project for the proposed study received approval from the Human Research Ethics Committee of Universidade Nove de Julho.
Selection of individuals - characterization of sample - Two groups will be composed of older adults (60 years or older) in treatment at the dental clinic of Universidade Nove de Julho. After verbal and written explanations of the study, those who agree to participate will sign a statement of informed consent approved by the Human Research Ethics Committee of Universidade Nove de Julho. The study will be conducted in compliance with the precepts stipulated in the Declaration of Helsinki (revised in Fortaleza, Brazil, 2013).
Calculation of sample size - Initially an error err=|(x_1 ) ̅-(x_2 ) ̅ | was established, where the mean values of groups G1 and G2 whose variances are σ_1^2e σ_2^2, respectively. The effect size was calculated by:
effect size=err/√(σ_1^2+σ_2^2 ) If the normal distribution hypothesis is rejected, the sample size should be corrected by approximately 5%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged 60 years or older using complete dentures
- •• Halitosis positive: ≥ 112 ppbin the gas chromatography test
排除标准
- •Dentate patients and edentulous with no complete denture hypersensitivity to the photosensitizing agent used in PDT, H2S < 112ppb
结局指标
主要结局
Halimetry (Gas Chromatography test)
时间窗: study completion an average of 1 year]
The portable Oral ChromaTM will be used for the assessment of halitosis. A syringe will be placed in the patient's mouth with the plunger completely inserted and the participant will breathe through the nose with the mouth closed for one minute.The plunger will then be withdrawn to fill the chamber with air. This procedure will be repeated. The gas injection needle will be placed on the syringe and the plunger will be adjusted to 0.5 ml. This air will be injected into the input of the device in a single motion. This procedure will be done before and immediately after treatment.
次要结局
未报告次要终点
研究者
Anna Carolina Ratto Tempestini Horliana
Principal Investigator
University of Nove de Julho