Oral Health Outcomes With Amphion Mouthwash as an Adjunct to Non-Surgical Periodontal Therapy
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean full-mouth Plaque Index (PI)
研究概览
简要总结
Periodontitis is a chronic inflammation caused by dental plaque that can destroy periodontal tissues. Current primary treatments include mechanical removal methods such as supragingival scaling and subgingival curettage. However, issues like microbial recolonization leading to inflammation recurrence exist, often necessitating the use of antimicrobial agents. Prolonged antibiotic use, however, can easily lead to bacterial resistance.
Amphion oral rinse is a novel biomimetic material mouthwash. It inhibits plaque regrowth by forming a long-lasting physical barrier and avoids flora imbalance. Compared with traditional antibiotics, this product has shown unique advantages in the adjuvant treatment of periodontal diseases. This study aims to evaluate the efficacy of Amphion rinse combined with conventional periodontal therapy in patients with stage I-IV periodontitis, including plaque control and inflammation improvement. Additionally, it will analyze its impact on the oral microbiome and collect user experience feedback to provide a reference for its clinical application.
详细描述
Periodontitis is a chronic inflammatory disease initiated by dental plaque biofilm as the primary etiological factor. Its main pathological feature is the progressive destruction of periodontal supporting tissues. Currently, mechanical removal of dental calculus and plaque remains the foundational treatment for periodontitis, primarily consisting of supragingival scaling, subgingival curettage, and root planing. However, such treatments have certain limitations: microorganisms from other areas in the oral cavity can recolonize the periodontal pockets, leading to disease recurrence. Therefore, the adjuvant use of antimicrobial agents is often necessary. Nevertheless, long-term or extensive use of antibiotics can easily induce bacterial resistance, resulting in the gradual evolution of various pathogenic bacteria associated with human diseases into multidrug-resistant strains.
Amphion oral rinse is a mouthwash developed based on cell membrane-mimicking polymer materials, with its core breakthrough being its "zero immunogenicity" property. By forming a long-lasting physical barrier on the oral surface, this product effectively inhibits plaque regrowth and avoids side effects such as flora imbalance caused by broad-spectrum antimicrobial activity. The duration of its barrier effect can exceed 7 days. Consequently, in the treatment of periodontal diseases, Amphion oral rinse demonstrates potential advantages over traditional antibiotic-based medications. It is expected to serve as an effective means of plaque control, complementing mechanical therapies and other approaches to eliminate periodontal pathogenic microorganisms, reduce or eliminate local inflammatory responses, and thereby achieve the goal of adjuvant treatment for periodontitis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 65 years old.
- •At least 20 natural teeth (excluding root remnants) present in the oral cavity.
- •Diagnosed with Stage I-IV periodontitis according to the 2018 new classification of periodontal diseases.
- •No impairment in vision, motor function, or cognitive ability, capable of understanding and cooperating with the study.
- •Not undergoing any orthodontic treatment and not wearing removable partial dentures during the study period.
- •Fully informed and voluntarily signed a written informed consent form.
排除标准
- •Individuals allergic to any component used in the study.
- •Pregnant or lactating women.
- •Those who have undergone periodontal treatments such as scaling, root planing, or used antimicrobial mouthwash within the past 3 months.
- •Those with a history of systemic hormone or antibiotic use within the past 3 months, or who are assessed as requiring adjunctive use of such medications during periodontal treatment.
- •Individuals with underlying systemic diseases that may affect the evaluation of periodontal status, including but not limited to: abnormal liver function, renal insufficiency, hematological diseases, neurological or psychiatric disorders, systemic bone diseases, diabetes, coronary heart disease, malignant tumors, etc.
- •Current or former smokers (including active or passive smoking), or users of other nicotine and tobacco products (such as e-cigarettes, chewing tobacco).
研究组 & 干预措施
Amphion® Mouthwash Group
Receives non-surgical periodontal therapy followed by irrigation and daily rinsing with Amphion® Mouthwash containing the active ingredient.
干预措施: Amphion® Mouthwash (Drug)
Placebo Mouthwash Group
Receives non-surgical periodontal therapy followed by irrigation and daily rinsing with a placebo mouthwash identical in appearance, odor, and taste but containing no active ingredient.
干预措施: Placebo Mouthwash (Drug)
结局指标
主要结局
Mean full-mouth Plaque Index (PI)
时间窗: Before treatment (baseline), and at 6 weeks and 3 months after treatment.
The PI assesses the thickness of plaque at the gingival margin. Four sites per tooth (mesial, distal, buccal, lingual) are scored from 0 (no plaque) to 3 (abundance of plaque). A lower score indicates better oral hygiene. The outcome will be reported as the mean PI score per patient across all examined sites.
次要结局
- Mean full-mouth Bleeding Index (BI)(Pre-treatment (baseline), 6 weeks post-treatment, and 3 months post-treatment)
- Mean Pocket Probing Depth (PPD)(Pre-treatment (baseline), 6 weeks post-treatment, and 3 months post-treatment)
- Mean Clinical Attachment Level (CAL)(Pre-treatment (baseline), 6 weeks post-treatment, and 3 months post-treatment)
- Microbial composition of subgingival plaque (relative abundance of key periodontal pathogens)(Pre-treatment (baseline), 6 weeks post-treatment, and 3 months post-treatment)
- Microbial composition of salivary plaque (total bacterial load and diversity)(Baseline (pre-treatment), 6 weeks, and 3 months post-treatment)
- Root surface hypersensitivity assessed by a Visual Analogue Scale (VAS)(Pre-treatment (baseline), 6 weeks post-treatment, and 3 months post-treatment)
- Alteration in taste sensation assessed by a 5-point Likert scale(6 weeks and 3 months post-treatment (during rinsing period).)
- Patient adherence to rinsing regimen (days of rinsing completed)(Through study completion, an average of 6 weeks)
- Periodontitis Staging and Grading(Baseline.)
- Medication History(Baseline)
- Oral Health-Related Quality of Life (OHRQoL)(Baseline, 3 months post-treatment)
- Age(Baseline)
- Gender(Baseline)
- Body Mass Index (BMI)(Baseline.)
- Tooth Brushing - Frequency(Before treatment (baseline), and at 6 weeks and 3 months after treatment.)
- Tooth Brushing - Method(Before treatment (baseline), and at 6 weeks and 3 months after treatment.)
- Tooth Brushing - Duration(Before treatment (baseline), and at 6 weeks and 3 months after treatment.)
- Use of Dental Floss/Interdental Cleaners(Before treatment (baseline), and at 6 weeks and 3 months after treatment.)