Impact of Non-Surgical Periodontal Therapy on Awake and Sleep Bruxism in Patients With Stage III-IV Periodontitis
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 Bruxism Episodes
研究概览
简要总结
This controlled pre-post study evaluates the effect of non-surgical periodontal therapy on awake and sleep bruxism in patients with Stage III and IV periodontitis. Bruxism activity and periodontal status will be assessed at baseline and three months after treatment.
详细描述
This is a non-randomized controlled pre-post clinical study designed to investigate the impact of periodontal treatment on awake and sleep bruxism in individuals with advanced periodontitis. Two groups will be included: a periodontitis group undergoing full non-surgical periodontal therapy (step 1 and 2), and a healthy control group receiving supragingival plaque removal and polishing. All participants will receive standardized oral hygiene instructions and motivation. Bruxism activity will be recorded using portable electromyography (EMG) devices at baseline and after three months, evaluating both sleep and awake bruxism through Bruxism Work Index (BWI) and Bruxism Time Index (BTI). Clinical periodontal parameters will also be collected at both time points to assess potential correlations with bruxism variation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 25 and 50 years
- •Good general health (ASA I or II)
- •Signed informed consent
- •Willingness to attend all study visits and follow instructions
- •For periodontitis group: diagnosis of Stage III or IV periodontitis according to the 2017 classification
- •For healthy control group: no clinical signs of periodontitis
排除标准
- •Systemic diseases or medications affecting the periodontium (e.g., diabetes, immunosuppressants)
- •Antibiotic or anti-inflammatory therapy within the last 3 months
- •Periodontal treatment in the last 6 months
- •Smoking more than 10 cigarettes/day
- •Use of occlusal splints or bruxism-targeted therapy in the past 6 months
- •Pregnancy or lactation
- •Any condition impairing the ability to cooperate or comply with the study protocol
结局指标
主要结局
Change in Bruxism Episodes
时间窗: Baseline and 3 months
Number of bruxism events measured using portable electromyographic (EMG) devices, at baseline and after periodontal/prophylactic treatment
Change in Bruxism Episodes
时间窗: Baseline and 3 months
Number of bruxism events measured using portable electromyographic (EMG) devices, at baseline and after periodontal/prophylactic treatment
次要结局
未报告次要终点
研究者
Nicola Discepoli
Associate Professor
University of Siena