A Prospective, Multicenter Study Comparing Healing After Treatment With the Sonendo GentleWave™ System as Compared to a Traditional Root Canal Therapy Literature Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 3
- 主要终点
- Number of Participants With a PAI Score of < 3, = 3, or = 4 or 5
研究概览
简要总结
A prospective, literature controlled, clinical study evaluating healing rates for the Sonendo GentleWave System in the treatment of 1st and 2nd molars indicated for root canal therapy.
详细描述
A prospective, non-significant risk device, literature controlled, study evaluating healing rates for the Sonendo GentleWave System in the treatment of 1st and 2nd molars indicated for root canal therapy.
All patients will receive root canal therapy with the Sonendo GentleWave System. All patients will be followed for 24 months post procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 75 years of age
- •Indicated for root canal therapy
- •First or second molar
- •Signed informed consent form
排除标准
- •Poor oral hygiene
- •Class II or III mobility
- •Open or incompletely formed root apices
- •Vertical fracture, horizontal fracture, or perforation below the Cemento-Enamel Junction (CEJ)
- •Previous pulpectomy or root canal therapy
- •Note: Additional exclusion criteria may apply.
研究组 & 干预措施
Sonendo GentleWave™ System
The Sonendo GentleWave System is intended to prepare, clean, and irrigate 1st and 2nd molar teeth indicated for root canal therapy.
干预措施: Sonendo GentleWave™ System (Device)
结局指标
主要结局
Number of Participants With a PAI Score of < 3, = 3, or = 4 or 5
时间窗: 12 months
The periapical index: A scoring system for radiographic assessment of apical periodontitis. Score of 1: Normal. Score of 2: Small changes in bone structure. Score of 3: Changes in bone structure with some mineral loss (bone loss). Score of 4: Periodontitis with well-defined radiolucent area (apical periodontitis). Score of 5: Severe Periodontitis with exacerbating features (apical periodontitis). Healed is defined by absence of a radiographic indication of apical periodontitis (PAI \<3) and absence of clinical signs and symptoms other than tenderness to percussion. Healing is defined by a reduction of radiolucency (if radiolucency is present at Baseline) combined with the absence of clinical signs and symptoms other than tenderness to percussion.
Periradicular Diagnosis
时间窗: 12 months
Symptomatic Apical Periodontitis: Inflammation, with clinical symptoms. Asymptomatic Apical Periodontitis: Inflammation with apical radiolucent area, does not produce clinical symptoms. Acute Apical Abscess: Inflammation characterized by rapid onset of clinical symptoms and swelling. Chronic Apical Abscess: Inflammation characterized by gradual onset, little or no discomfort, presence of a sinus tract. Condensing Osteitis: Diffuse radiopaque lesion representing a localized bony reaction to inflammation. Healed is defined by absence of a radiographic indication of apical periodontitis (PAI \<3) and absence of clinical signs and symptoms other than tenderness to percussion. Healing is defined by a reduction of radiolucency (if radiolucency is present at Baseline) combined with the absence of clinical signs and symptoms other than tenderness to percussion.
次要结局
未报告次要终点