Efficacy of Regular Home Use of Dual-light Photodynamic Therapy on Oral Health in Adolescents Undergoing Fixed Orthodontic Treatment - Randomized, Controlled Clinical Study
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
- Change in Visible plaque index (VPI)
研究概览
简要总结
This study is designed to determine the efficacy of the Lumoral method on oral health in adolescents undergoing fixed orthodontic treatment. Improved supragingival plaque control can help to also sustain the subgingival plaque management in the long term. In addition, the device might have a photobiomodulation effect on periodontal tissues.
详细描述
Orthodontic treatment is one of the most common dental treatments in children and adolescents. The use of fixed orthodontic appliances makes it difficult for the patients to keep their oral hygiene to an optimum level of cleanliness. Poor oral hygiene attracts significant plaque accumulation around the fixed orthodontic treatment appliances, and subsequent white spot lesions can occur rapidly, usually on the cervical and middle third of the buccal surfaces of bracketed teeth. Patients with the fixed orthodontic treatment appliances have an increased risk of caries and gingivitis.
The Lumoral is a CE-marked medical device developed to provide a potent, targeted antibacterial action on dental plaque in a home environment. The device mechanism of action is antibacterial photodynamic therapy (aPDT). The device is used by swishing a mouth rinse, which has a strong adherence to dental plaque. The plaque-adhered photoactive mouth rinse can be activated by a simple to use light applicator. Preliminary results have shown a promising anti-inflammatory response in addition to plaque reduction.
Forty (40) subjects undergoing fixed orthodontic treatment are randomized to the Lumoral treatment group or the control group. All subjects shall receive polishing and oral hygiene instruction. All patients shall be assessed for the clinical measurements including visible plaque index (VPI), bleeding on probing (BOP), and orthodontic plaque index (OPI) at baseline and at 4 weeks and 12 weeks after baseline. In addition, microbiological analyses shall be performed at baseline and at 12 weeks after baseline.
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
盲法说明
The participants, care providers, and investigators shall be masked before the first measurements. The randomization will be conducted after the first measurements.
入排标准
- 年龄范围
- 15 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age of 15-18 years old
- •starting fixed orthodontic treatment
- •good oral hygiene according to the dentist's assessment
- •absence of periodontal disease and lack of oral lesion
- •signed a written consent form, including information to caregivers.
排除标准
- •any chronic diseases
- •medications that could influence the study (according to the dentists' assessment)
- •active caries or a supposed high risk of caries
- •gingivitis (bleeding on probing >10%)
- •use of antiseptic mouthwashes
- •use of antibiotics or anti-inflammatory therapy within 3 months before entering the study or during the study
- •unable to cooperate with the protocol.
- •pregnancy or lactation
结局指标
主要结局
Change in Visible plaque index (VPI)
时间窗: 12 weeks
* A full-mouth assessment, measured at six sites per tooth. * Dichotomous scoring to each site of the tooth as plaque "1 present" and "0 absent" * VPI is reported as the percentage (%) of sites with plaque. * Calculation formula: number of sites with plaque/ 6 times number of teeth
次要结局
- Change in Bleeding on probing (BOP)(12 weeks)
- Change in Orthodontic plaque index (OPI)(12 weeks)
- Change in periodontal microbiological flora(12 weeks)