The Effect of Non-surgical Periodontal Treatment on the Biomechanical Properties of the Periodontal Tissues, a Prospective Comparative Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Probing depth (PPD) at test tooth
研究概览
简要总结
Investigation of the biomechanical properties of the periodontal tissues in patients with periodontal disease. Non-surgical periodontal therapy will be assessed between baseline and 30 post-op by general clinical measurements (KT, PPD, CAL, BOP) as well as by biomechanical analysis and compared.
详细描述
The study is designed as a prospective single center comparative clinical trial to investigate the biomechanical properties of the periodontal tissues in 30 patients with periodontal disease.
Success of non-surgical periodontal therapy between baseline and 30 post-op will be assessed by general clinical measurements (KT, PD, CAL, BOP) as well as by biomechanical analysis. Besides assessment for regular treatment effectiveness, safety parameter such as wound healing and adverse events will be assessed.
Additionally 10 periodontally healthy persons without local inflammation and bone loss shall be monitored and used a control group for reference to the test teeth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Moderate/advanced/severe periodontitis
- •Intact anterior dentition upper yaw.
- •Expected performance of adequate oral hygiene
- •Subjects must have voluntarily signed the informed consent form before any study related procedures
- •Males and females with at least 18 years of age
- •Subjects must be committed to the study and the required follow-up visits
- •Subject must be judged in good general health as assessed by the investigator at time of non-surgical therapy
排除标准
- •Any contraindications for subgingival instrumentation
- •Uncontrolled diabetes or other uncontrolled systemic diseases
- •Disorders or treatments that compromise wound healing
- •Medical conditions requiring chronic high dose steroid therapy
- •Bone metabolic diseases
- •Radiation or other immuno-oppressive therapy
- •Chronic anti-inflammatory treatment (≥3 times per week) within 4 weeks prior to treatment
- •Presence of oral lesions (such as ulceration, malignancy)
- •Mucosal diseases (e.g., lichen planus, mouth ulcer)
- •History of malignant disease in the oral cavity or previous radiotherapy to the head or neck
- •Treatment with an investigational drug or device within the 30 day period immediately prior to therapy on study day 0
- •Female subjects who are nursing, pregnant, or plan to become pregnant
- •Antibiotic treatment
结局指标
主要结局
Probing depth (PPD) at test tooth
时间窗: 3 months
mean PPD (mm)
Biomechanical analysis
时间窗: 3 months
Tooth displacement (mm)
Clinical attachment level (CAL)
时间窗: 3 months
mean attachment level (mm)
Bleeding on Probing (BoP)
时间窗: 3 months
mean BoP (%)
次要结局
- 3.General Oral Health Assessments Indices (GOHAI)(3 months)
- 7.General Oral Health Assessments Indices (GOHAI)(3 months)
- 2.General Oral Health Assessments Indices (GOHAI)(3 months)
- 4.General Oral Health Assessments Indices (GOHAI)(3 months)
- 5.General Oral Health Assessments Indices (GOHAI)(3 months)
- 1.General Oral Health Assessments Indices (GOHAI)(3 months)
- 6.General Oral Health Assessments Indices (GOHAI)(3 months)
- 10.General Oral Health Assessments Indices (GOHAI)(3 months)
- Biotype/keratinized tissue width (KT)(3 months)
- 8.General Oral Health Assessments Indices (GOHAI)(3 months)
- 11.General Oral Health Assessments Indices (GOHAI)(3 months)
- 9.General Oral Health Assessments Indices (GOHAI)(3 months)
- 12.General Oral Health Assessments Indices (GOHAI)(3 months)
研究者
Karin Jepsen
Associated Professor
University of Bonn