A Comparative Evaluation of the Effects of Three Different Mouthwashes on Salivary pH of the Oral Cavity in Fixed Orthodontic Patients – A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
研究概览
简要总结
Title of the study: A Comparative Evaluation of the Effects of Three Different Mouthwashes on Salivary pH of the Oral Cavity in Fixed Orthodontic Patients – A Randomized Clinical Trial (SMILE Trial)
Participants were enrolled in the study, and they were randomly allocated to three different groups containing three different mouthwashes. Participants were asked to spit the saliva before mouthwash use, immediately after 5 minutes of mouthwash usage, and after 1 week of regularly using mouthwash. Salivary PH determined at the baseline (T0), after 5 min of mouthwash usage (T1), and after 1 week (T2). This study aimed to reduce demineralisation in enamel, which will cause white spot lesions and caries if an acidic oral environment is present in the oral cavity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 14.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 12–30 years undergoing fixed orthodontic treatment.
- •Patients with full-mouth fixed orthodontic appliances in both arches.
- •Patients who have been undergoing fixed appliance therapy for a minimum of 3 months.
- •Patients with good general health and no known systemic diseases affecting salivary secretion or pH.
- •Patients with normal salivary flow rate.
- •Patients with good oral hygiene and no active oral infections at the time of sample collection.
- •Patients willing to use the allocated mouthwash according to the study protocol.
- •Patients who provide written informed consent (and parental consent for minors).
排除标准
- •Patients with systemic diseases (e.g., diabetes, Sjögren’s syndrome) or conditions affecting salivary flow or composition.
- •Patients taking medications that alter salivary flow or pH (e.g., antidepressants, antihistamines).
- •Patients with active dental caries, periodontal disease, or oral lesions.
- •Patients using any mouthwash, probiotic, or fluoride rinse other than the study mouthwash during the study period.
- •Patients with removable orthodontic appliances or aligners.
- •Patients who have undergone professional oral prophylaxis within the previous 2 weeks.
- •Patients who are uncooperative or unwilling to comply with study instructions.
研究者
Dr Sruthi J
Adhiparasakthi Dental College and Hospital