Treatment of Intraosseous Periodontal Pockets by Non-surgical Therapy With Micro-instruments and Application of Amelogenins. A Randomized-controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Change of Clinical Attachment Level (CAL) gain (millimeters)
研究概览
简要总结
The aim of the present investigation will be evaluate the healing of periodontal intraosseous defects following Minimally Invasive Non Surgical Debridement (MINSD) and application of amelogenins, compared to MINSD alone.
A total of 22 patients will be enrolled, selected by inclusion and exclusion criteria and randomly divided in two groups: amelogenin (A) and no-amelogenin group (B).
详细描述
The objective of the study will be compare the healing of periodontal intraosseous defects following treatment with Minimally Invasive Non Surgical Debridement (MINSD) and application of amelogenins compared to MINSD alone.
Twenty-two patients with intraosseous periodontal defects will be randomly assigned to treatment with MINSD and application of amelogenins (A Group) or MINSD alone (B Group).
Primary outcome will be "Clinical Attachment Level" (CAL) gain, while the secondary outcomes will be "Probing Depth" (PD), "Gingival Recession" (GR) and "Radiographic Defect Angle" (RDA).
After local anesthesia, in A group MINSD will be performed using an ultrasonic scaler with fine tips and micro-curette; then, amelogenins in gel will be applied in the intraosseous periodontal pockets using a sterile syringe with plasticized needle.
In the B group, only subgingival mechanical debridement (MINSD) will be performed with an ultrasonic scaler with fine tips and micro-curette.
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
- Single (Participant)
盲法说明
Only patients will be unaware of the type of treatment performed, with prior written informed consent. So, they will be divided in the two groups of study after a process of randomization
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients diagnosed with periodontitis;
- •Age ≥ 18 years old;
- •Presence of at least 10 teeth per arch;
- •Presence of at least two teeth with Probing Depth (PD) ≥ 5 mm per quadrant;
- •Presence of at least one intraosseous pocket;
- •Single-rooted and multi-rooted teeth.
排除标准
- •Patients with systemic diseases;
- •Prolonged antibiotic or anti-inflammatory treatment within 4 weeks prior to periodontal therapy;
- •Pregnant or lactating;
- •Tobacco smokers (≥ 10 cigarettes per day);
- •Multi-rooted teeth with furcation involvement;
- •Third molars.
结局指标
主要结局
Change of Clinical Attachment Level (CAL) gain (millimeters)
时间窗: baseline and 6 months after periodontal therapy
Distance from the cementoenamel junction to the bottom of the pocket
次要结局
- Change of Probing Depth (PD) (millimeters)(baseline and 6 months after periodontal therapy)
- Change of Gingival Recession (GR) (millimeters)(baseline and 6 months after periodontal therapy)
- Change of Radiographic Defect Angle (RDA) (grade °)(baseline and 6 months after periodontal therapy)
研究者
Luca Ramaglia
Clinical Professor
Federico II University