Laboratory and Clinical Evaluation of an Innovative Mouthwash in School-Aged Children With Fixed Orthodontic Appliances
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Orthodontic Plaque Index (OPI)
研究概览
简要总结
Fixed metal orthodontic appliances create additional plaque-retentive areas around brackets, archwires and ligatures, making mechanical plaque control more difficult in children and adolescents. Increased plaque accumulation may contribute to gingival inflammation, bleeding, halitosis and early enamel changes. Therefore, adjunctive preventive agents, including mouthwashes, may be clinically useful as part of a comprehensive oral hygiene program during fixed orthodontic treatment.
The aim of the study is to evaluate the clinical effectiveness and tolerability of a test mouthwash in children and adolescents with fixed orthodontic appliances by monitoring plaque accumulation, gingival inflammation, gingival bleeding and halitosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged 12 to 17 years.
- •Presence of fixed metal orthodontic appliances placed at least 6 months before enrollment.
- •Generalized plaque-induced gingivitis.
- •Full Mouth Bleeding Score greater than 30%.
- •Gingival Index greater than 0.95 according to Loe and Silness.
- •Written informed consent obtained from a parent or legal guardian.
- •Participant willingness to comply with the study protocol.
排除标准
- •Refusal to participate or withdrawal of informed consent.
- •Non-compliance with the intervention regimen or inability to attend follow-up visits.
- •Development of an adverse reaction or condition requiring discontinuation.
- •Antibiotic or antimicrobial therapy during follow-up if it may affect the study outcomes.
- •Presence of concomitant systemic diseases.
- •Current systemic medication intake that could influence oral health or inflammatory status.
- •Use of systemic or local antimicrobial agents during the previous 3 months, including mouthwashes, gels, chewing gums or other local oral agents.
- •Known allergy or hypersensitivity to any component of the tested mouthwash formulations.
- •Use of removable orthodontic appliances only. Inability or unwillingness to follow the study instructions.
结局指标
主要结局
Orthodontic Plaque Index (OPI)
时间窗: Baseline, day 7, day 21, and 3 months
The Orthodontic Plaque Index focuses on the areas around the bracket, which represents an additional plaque-retentive factor. The dentition is divided into sextants and plaque accumulation is scored from 0 to 4. The mesial, distal, incisal and cervical areas around each bracket are evaluated. The highest score among all sextants defines the oral hygiene level and identifies the need for preventive measures. Registry field data Code 0 No plaque accumulation is detected. Code 1 Plaque accumulation is detected on one tooth surface around the bracket base. Code 2 Plaque accumulation is detected on two tooth surfaces around the bracket base. Code 3 Plaque accumulation is detected on three tooth surfaces around the bracket base; increased risk of caries and gingivitis is assumed. Code 4 Plaque accumulation is detected on all tooth surfaces around the bracket base and/or gingival inflammation is present.
Gingival Index (Loe & Silness)
时间窗: Baseline, day 7, day 21, and 3 months
The index evaluates color, contour and bleeding of the gingival tissues. A World Health Organization (WHO) 621 periodontal probe is used to examine the gingival sulcus, and bleeding is recorded within 10 seconds. Code 0 Normal gingiva. Code 1 Mild inflammation: slight color change and slight edema, without bleeding on probing. Code 2 Moderate inflammation: redness, edema and glazing, with bleeding on probing. Code 3 Severe inflammation: marked redness and edema, ulceration and tendency to spontaneous bleeding.
Full Mouth Bleeding Score (FMBS)
时间窗: Baseline, day 7, day 21, and 3 months
FMBS assesses provoked bleeding from the gingival sulcus using a WHO 621 periodontal probe. Bleeding is recorded within 10 seconds and marked as present (+) or absent (-). The index is calculated as the percentage of gingival sites with provoked bleeding from all examined sites for each child.
Full Mouth Plaque Score (FMPS)
时间窗: Baseline, day 7, day 21, and 3 months
Dental plaque accumulation was assessed using the Full Mouth Plaque Score. The presence of visible plaque was recorded on tooth surfaces, and the result was expressed as the percentage of plaque-positive sites. Lower percentages indicate improved plaque control.
次要结局
- Halitosis Assessment(Baseline, day 7, day 21, and 3 months)