Dual-light Antibacterial Photodynamic Therapy as an Adjunctive Treatment to Topical Corticosteroid Treatment in Patients With Gingival Involvement of Oral Lichen Planus - a Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Pain score symptom diary (based on Visual Analogue Scale - VAS)
研究概览
简要总结
This study is designed to investigate the effectiveness of plaque control intervention by home-use dual-light aPDT Lumoral -device as an adjunctive or alternative treatment to triamcinolone acetonide (TCA) mouth rinse or other topical corticosteroid treatment on the symptoms and clinical appearance of symptomatic gingival involvement of oral lichen planus (OLP).
详细描述
Oral Lichen Planus (OLP) is a relatively common, chronic immune-mediated mucocutaneous disease,that usually occurs on the oral mucosa surfaces. Oral lesions are commonly multiple with a bilateral and symmetrical localization. Most affected sites in the oral cavity are the buccal and lingual mucosa, and the gingiva. Approximately 10% of patients with OLP present manifestations in the gingiva.
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. Use of the device can improve supragingival plaque control. Preliminary results have shown a promising anti-inflammatory response in addition to plaque reduction.
A total of 60 subjects with histologically confirmed diagnosis of OLP with gingival involvement are enrolled to the study. The subjects are randomized to a study group and a control group. Both groups will use topical corticosteroid treatment for two weeks. In addition, the study group will use Lumoral-device initially once a day.
All the subjects shall be assessed for desquamative gingivitis clinical score (DGCS), Escudier Index (EI), visible plaque index (VPI), bleeding on probing index (BOP), pain score (VAS), aMMP-8 inflammation marker and oral candidosis. These analyses shall be performed at baseline and at 4 week, 3, 6 and 12 months after the treatment started.
In addition, psychosocial factors shall be assessed by the graded chronic pain scale (GCPS), the oral health impact profile (OHIP-14) and the generalized anxiety disorder (GAD-7) questionnaires at baseline and at 6 and 12 months after the treatment initiation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
A sealed envelope system shall be used for randomization.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of OLP with bilateral symmetrical lesions and gingival involvement
- •Able to provide a written consent
- •Willing and able to complete questionnaires
- •Able to co-operate with the treatment protocol and avoid any other oral hygiene measures outside of the study protocol
排除标准
- •Lichenoid lesions suspected to be induced by contact allergy or drugs
- •Any treatment for OLP in two weeks prior to the study/ a history of topical therapy for OLP in the past 2 weeks or systemic therapy in the past 4 weeks;
- •Pregnant or lactating
- •Photosensitivity
- •Use of antibiotics within 2 weeks prior the study
研究组 & 干预措施
Study group
Subjects in the study group will use the Lumoral device five to seven times a week according to the verbal and written instructions provided to them. In addition, they will brush their teeth twice daily in their customary manner while using the provided sonic toothbrush and regular toothpaste.
干预措施: Lumoral treatment (Device)
Study group
Subjects in the study group will use the Lumoral device five to seven times a week according to the verbal and written instructions provided to them. In addition, they will brush their teeth twice daily in their customary manner while using the provided sonic toothbrush and regular toothpaste.
干预措施: Standard oral hygiene self care (Other)
Control group
Subjects in the control group will brush their teeth in their customary manner twice daily while using the provided sonic toothbrush and regular toothpaste. They will not receive any additional intervention.
干预措施: Standard oral hygiene self care (Other)
结局指标
主要结局
Pain score symptom diary (based on Visual Analogue Scale - VAS)
时间窗: 12 months
Improvement in average Pain score (VAS) symptom diary during the 12 month study period. Assessments: 1. '365 Average pain score' (VAS) is determined by calculating the average of the pain scores marked in the diary during the total surveillance period of one year; 2. '52 Average pain score' (VAS) is determined by calculating the average of the pain scores of calendar weeks during the total surveillance period of one year; 3. 'Positive 52 Average pain score' (VAS) is determined by including the '52 Average pain scores' of those calendar weeks, which have VAS average over 2.
次要结局
- Graded chronic pain scale (GCPS) questionnaire (authors: Von Korff M et al. 1992)(12 Months)
- Oral Health Impact Profile (OHIP-14) questionnaire (author: Slade 1997)(12 Months)
- aMMP-8(12 Months)
- Bleeding on probing index (BOP)(12 Months)
- Oral Lichen Planus (OLP) relapse(12 Months)
- Escudier Index (EI)(12 Months)
- Visual Analogue Scale - VAS(3 Months)
- Generalized anxiety disorder (GAD-7) questionnaire (authors: Spitzer RL et al. 2006)(12 Months)
- Use of corticosteroid treatment(6 Months)
- Desquamative gingivitis clinical score (DGCS)(12 Months)
- Visible plaque index (VPI)(12 Months)
- Oral candidosis(12 Months)
- Visual Analogue Scale - VAS(12 Months)
- Visual Analogue Scale - VAS(6 Months)