Comparative Effectiveness in the Management of Irreversible Pulpitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Percentage of patients with a successful outcome of pulpotomy versus RCT
研究概览
简要总结
This project addresses a central question within the practice of dentistry: Is a pulpotomy procedure effective in the treatment of a tooth with symptomatic irreversible pulpitis and normal periapex? In addition, the project seeks to identify clinical and molecular biomarkers that are predictive of the success of pulpotomy.
详细描述
In this study, patients will be randomized to two groups. All patients will have a diagnosis of irreversible pulpitis with normal apical tissues. The groups will be root canal treatment and pulpotomy. The patients will be followed clinically and radiographically for 2 years following the treatment. Predictors of the outcome of pulpotomy will be clinical and laboratory-based parameters.
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
- None
入排标准
- 年龄范围
- 12 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Maxillary or mandibular first or second mature permanent molars with carious lesions or restorations (excluding crowns), with signs and symptoms of symptomatic irreversible pulpitis (defined as spontaneous pulpal pain and cold hyperalgesia >30 seconds), and normal apical tissues.
- •Tooth is responsive to cold and electrical pulp testing.
- •Patients aged ≥12 years for first molars and ≥16 years for second molars.
排除标准
- •Evidence of Pulp Necrosis or Apical Periodontitis, preoperatively or upon inspection of an exposure site
- •Teeth that are badly broken down and/or are not restorable.
- •Teeth with mechanical allodynia assessed by registering bite force that is at least 50N lower than the contralateral side.
- •Teeth with radiographic evidence of internal, or external cervical, inflammatory or replacement root resorption, or with complete pulp canal obliteration.
- •Radiographic evidence of PDL space wider than three times normal width
- •Clinical evidence of swelling or sinus tract
- •Periodontal pocket probing depth ≥5 mm in any site around the tooth.
- •Clinical evidence of cracks connecting mesial and distal surfaces and/or extending in pulp chamber or associated with periodontal pockets ≥ 5 mm.
- •History of taking centrally acting drugs (e.g., tricyclic antidepressants), which interfere with the release of pain mediators and/or modify pain experience, within the previous 6 months.
- •Use of medications that affect the host response such as methotrexate, corticosteroids or cyclosporin.
- •Patients on immunosuppressive agents, chronic corticosteroid use, autoimmune disease, or other immunocompromising diseases or medications.
- •Patients who require IV sedation or general anesthesia for their dental treatment.
- •Teeth with full coverage crowns.
- •Teeth undergoing active orthodontic movement.
- •Teeth that require elective RCTx to place a post for restorative purposes.
- •Teeth with no contralateral molars with normal pulp and periapical tissues for bite and pulp testing controls.
- •Teeth in the pulpotomy group in which, following complete pulpotomy, bleeding does not stop after 10 minutes with 3-4% hypochlorite cotton pellet. These will be considered treatment failure and treated with RCTx.
研究组 & 干预措施
Root canal treatment (RCT)
For cases with this diagnosis RCT is the standard of care and will be done according to clinically approved protocols
干预措施: RCT (Procedure)
Pulpotomy
Pulpotomy with tricalcium silicates has shown high clinical success in these cases. However, it is not known how this success compares to RCT under similar conditions and with an intent-to-treat study design, which will be employed here.
干预措施: Pulpotomy (Procedure)
结局指标
主要结局
Percentage of patients with a successful outcome of pulpotomy versus RCT
时间窗: From baseline through 2 years
A composite of clinical and radiographic findings and incidence of follow up procedures
次要结局
- Determine prognostic validity of preoperative hyperalgesia in determining the outcome of pulpotomy(From baseline to two years)
- Determine prognostic validity of a set of pulpal inflammatory proteins in determining the outcome of pulpotomy(From baseline to 2 years)
研究者
Ashraf Fouad
Professor and Chair
University of Alabama at Birmingham