The Role of Green Tea Mouthwash in Managing Halitosis, Periodontal Health and Stress: A Comprehensive Study in Orthodontic Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in Halitosis Level Measured by Halimeter
研究概览
简要总结
This randomized, double-blind, four-arm clinical trial evaluates the effects of green tea mouthwash on halitosis, periodontal health, salivary stress biomarkers, and oxidative stress in patients undergoing fixed orthodontic treatment. Participants aged 15-25 years are assigned to one of four mouthwash groups: two green tea mouthwashes, a fluoride mouthwash, or normal saline. Outcomes are assessed before treatment and during follow-up using halitosis measurements, periodontal assessments, salivary biomarkers, and microbiological analysis.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and outcome assessors are blinded to group allocation. Mouthwashes are provided in opaque bottles, and laboratory analyses are performed without knowledge of treatment allocation.
入排标准
- 年龄范围
- 15 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 15-25 years. Patients requiring or wearing upper and lower fixed orthodontic appliances in the initial phase of treatment.
- •No craniofacial anomalies. Good oral hygiene according to the plaque index criterion stated in the study protocol.
排除标准
- •Current use of antibiotics or medications that may affect oral microbiota.
- •Extensive dental caries. Severe periodontal disease. Mouth breathing. Systemic conditions. Pregnancy or breastfeeding. Unable to adhere to the study protocol or attend follow-up appointments.
研究组 & 干预措施
Green Tea Mouthwash A
Participants receive green tea mouthwash A during fixed orthodontic treatment
干预措施: Green Tea Mouthwash A (Other)
Green Tea Mouthwash B
Participants receive green tea mouthwash B during fixed orthodontic treatment
干预措施: Green Tea Mouthwash B (Other)
Fluoride Mouthwash
Participants receive a fluoride-containing mouthwash during fixed orthodontic treatment
干预措施: Fluoride Mouthwash (Other)
Placebo
Participants receive normal saline mouthwash during fixed orthodontic treatment
干预措施: Normal Saline Mouthwash (Other)
结局指标
主要结局
Change in Halitosis Level Measured by Halimeter
时间窗: Baseline, 4 months, 5 months, and 6 months
Halitosis is assessed using a Halimeter. Two readings are obtained at each assessment and averaged. Results are recorded in parts per billion (ppb)
次要结局
- Change in Salivary Cortisol Level(Baseline, 4 months, 5 months, and 6 months)
- Change in Malondialdehyde (MDA) Level(Baseline, 4 months, 5 months, and 6 months)
- Change in Salivary Total Antioxidant Capacity (TAC)(Baseline, 4 months, 5 months, and 6 months)
- Self-Perceived Halitosis and Oral and Dental Health(day 0 and after 3 months)
研究者
Hind Hadi Enad
PhD Candidate
Universiti Sains Malaysia