Assessment of Photodynamic Therapy With Annatto and Led for the Treatment of Halitosis in Mouth-Breathing Children: Randomized Controlled Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Changes in Halimetry Results
研究概览
简要总结
Objective: To assess the effectiveness of antimicrobial photodynamic therapy (aPDT) employing an annatto-based (20%) dye combined with blue LED for the treatment of halitosis in mouth-breathing children. Methods: Fifty-two children six to twelve years of age with diagnoses of mouth breathing and halitosis (score of ≥ 3 on Breath Alert® portable breath meter) were randomly allocated to two groups (n = 26). Group 1: brushing, dental floss and aPDT applied to middle third of the dorsum of the tongue. Group 2: brushing, dental floss and tongue scraper. Breath meter results before, immediately after treatment as well as seven and 30 days after treatment were compared. The normality of the data will be determined using the Shapiro-Wilk test. Parametric data will be submitted to analysis of variance and nonparametric data will be compared using the Kruskal-Wallis test. The results of each treatment in the different periods of the study will be compared using the Wilcoxon test.
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
- Single (Outcomes Assessor)
盲法说明
The Breath Alert, as the device that will be used to determine the presence of halitosis, is blinded to groups/participants.
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of mouth breathing (performed using the calibrated Glatzel mirror test, water retention test and a questionnaire);
- •Halitosis presenting a score equal or greater than 2, in the Breath Alert analysis.
排除标准
- •Nasal breathers;
- •Dentofacial anomalies (such as cleft lip, cleft palate and nasopalatine);
- •Undergoing orthodontic and/or orthopedic treatment;
- •Undergoing cancer treatment;
- •Systemic alterations (gastrointestinal, renal, hepatic);
- •Under antibiotic treatment for up to 1 month before the research;
- •Fissured or grooved tongue.
结局指标
主要结局
Changes in Halimetry Results
时间窗: Baseline, immediately after treatment, after 7 days and after 30 days.
The Breath Alert® device was used following the manufacturer's instructions and disinfected after each use. The device was shaken four or five times prior to each use to eliminate any residual odors. A "beep" was emitted upon opening the upper compartment of the device and a second "beep" was emitted when the participant blew into the frontal air input (air flow passage). After a third "beep", breath odor was measured and scored on a scale of 0 to 8 points. If the letter ''C'' appeared, indicating an error, the procedure was repeated. A score ≥ 2 points was considered indicative of halitosis.
次要结局
未报告次要终点
研究者
Sandra Kalil Bussadori
Principal Investigator
University of Nove de Julho