Outcome of Complete Pulpotomy in Healthy and Type 2 Diabetic Patients in Permanent Teeth with Irreversible Pulpitis - a Preliminary Prospective Interventional Study.
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
- Treatment outcome
研究概览
简要总结
Endodontic research on the effects of DM on pulp tissues is scarce. Diabetic human and animal histological research demonstrated a decreased reparatory response in the pulp, resulting in chronic pulp inflammation and reduced dentin bridge formation. To date, there is no human clinical trial examining the impact of diabetes mellitus on teeth with irreversible pulpitis. As a result of the paucity of data in the literature, there is a clinical dilemma whether to recommend vital pulp therapy techniques or root canal treatment in diabetic patients with irreversible pulpitis.
To the best of our knowledge, no prospective study has evaluated the outcome of complete pulpotomy in T2DM patients and healthy controls with irreversible pulpitis. The aim of this preliminary study is to compare and evaluate the success rates of pulpotomy in healthy and type 2 diabetes mellitus patients in mature permanent teeth presenting with clinical symptoms of irreversible pulpitis.
详细描述
Introduction:
Endodontic disease can affect both the pulp and the periapical areas of the tooth. The resultant immune-pathological reaction could be acute or chronic inflammation, depending on the ability of pulp and periapical tissue to respond to and recover from the noxious stimuli. T2DM has been recognized as a crucial factor affecting the pulpal and periapical tissues, in terms of susceptibility, progression, and healing. Endodontic research on the effects of DM on pulp tissues is scarce. Diabetic human and animal histological research demonstrated a decreased reparatory response in the pulp, resulting in chronic pulp inflammation and reduced dentin bridge formation. To date, there is no human clinical trial examining the impact of diabetes mellitus on teeth with irreversible pulpitis. As a result of the paucity of data in the literature, there is a clinical dilemma whether to recommend vital pulp therapy techniques or root canal treatment in diabetic patients with irreversible pulpitis.
To the best of our knowledge, no prospective study has evaluated the outcome of complete pulpotomy in T2DM patients and healthy controls with irreversible pulpitis. The aim of this preliminary study is to compare and evaluate the success rates of pulpotomy in healthy and type 2 diabetes mellitus patients in mature permanent teeth presenting with clinical symptoms of irreversible pulpitis.
AIM The aim of this study is to evaluate and compare the outcome of complete pulpotomy in healthy and type 2 diabetes mellitus patients presenting with clinical and radiographic signs and symptoms indicative of irreversible pulpitis.
OBJECTIVES
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The investigator and the outcome assessor will be blinded with the participants preoperative characteristics and allocation group.
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
- •Type 2 diabetes mellitus with HbA1c > 6.5% with no other co-morbidities.
- •Age and gender matched healthy patients
- •Age between 18 - 70 years.
- •Mature permanent teeth with clinical and radiographic signs and symptoms indicative of irreversible pulpitis (PAI score ≤2)
- •Tooth showing positive response to pulp sensibility testing.
排除标准
- •Patients with immunocompromised diseases or systematic diseases (other than diabetes mellitus)
- •Smokers, pregnant and lactating women
- •Teeth with immature roots or retained deciduous tooth.
- •Bleeding could not be controlled in ≥8 minutes.
- •Tooth with signs and symptoms of apical periodontitis.
- •Tooth with probing depth more than 4mm.
- •Positive history of antibiotic use in the past 1 month or requiring antibiotic prophylaxis and/or analgesic usage in past 3 days.
结局指标
主要结局
Treatment outcome
时间窗: 6 and 12 month follow-up.
Outcome of complete pulpotomy in healthy and diabetic patients through clinical and radiographic findings.
次要结局
- 1) Effect of treatment on glycated haemoglobin levels in diabetic patients(3 months post-treatment)