Influence of Type 2 Diabetes Mellitus on the Outcome of Full Pulpotomy in Teeth with Symptomatic Irreversible Pulpitis: A Prospective study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Primary outcome is to evaluate the clinical and radiographic outcome of full pulpotomy performed in permanent mature mandibular molars indicative of symptomatic irreversible pulpitis in Type 2 diabetes mellitus patients (HbA1c greater or equal then 6.5%) and non diabetic patients (HbA1c less then 6.5%) and compare them.
研究概览
简要总结
Teeth diagnosed with irreversible pulpitis are characterized by having spontaneous, intense and lingering pain (often lasting 30 seconds or more after stimulus removal) that is often triggered by thermal stimuli.The preferred treatment of choice in such a scenario will be conventional non- surgical endodontic treatment (NSET) which has a success rate of 95% with an excellent prognosis. In recent times, there has been a paradigm shift in treating teeth diagnosed with SIP with Vital Pulp Therapy (VPT). “Full pulpotomy refers to the complete removal of the coronal pulp and application of a biomaterial directly onto the pulp tissue at the level of the root canal orifice, prior to placement of a permanent restorationâ€. Taha NA et al 2018,2022 study, Cushley et.al, Jassal A et.al, Kumar V et al studies had a success rate of 83% to 98% full pulpotomy of symptomatic irreversible pulpitis teeth, all these studies had inclusion criteria of healthy individuals and exclusion of patients having any systemic disease. Type 2 diabetes mellitus (T2DM) is a global health concern characterized by insulin resistance and hyperglycemia.Type2 DM group exhibited a higher proportion of M1 macrophages. Various cytokines produced by M1 macrophages could be responsible for delayed wound healing. Diabetic patients may present with altered inflammatory responses and delayed healing as concluded in a prospective study conducted by Arya S et al (2017). The authors compared the success of primary root canal treatment between type 2 diabetic and nondiabetic patients and found that diabetes mellitus (DM) may have a negative impact on the outcome of endodontic treatment in terms of periapical healing.This also suggests that T2DM may have an effect on the outcomes of dental treatments like pulpotomy. While full pulpotomy has shown favorable outcomes in systemically healthy patients, it is crucial to assess whether similar results can be expected in patients with T2DM.There is a gap in the current literature on the outcomes of full pulpotomy specifically in patients with T2DM, and hence this study planned to conduct.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Diabetic Patients:- 1.Patients with a history of T2DM having HbA1c levels ≥ 6.5% of either gender belonging to age range from 30 to 65 years.
- •2.Permanent mandibular first & second molars having carious lesion diagnosed clinically and radiologically as symptomatic irreversible pulpitis.
- •3.Teeth with positive response to electric pulp test and cold test.
- •4.Radiographic examination showing periapical index score (PAI) of 1 or
- •5.Teeth with restorable carious lesions.
- •6.Periodontally sound teeth.
- •7.Absence of any signs of pulpal necrosis including swelling or sinus tract.
- •Non Diabetic Patients:- 1.Patients having HbA1c levels < 6.5% of either gender belonging to age range from 30 to 65 years.
排除标准
- •Diabetic patients’ exclusion criteria- 1.Radiographic examination showing periapical index score (PAI) of 3-5 2.Teeth with cracks, cusp fractures, subgingival caries and poor periodontal health.
- •3.Patients with systemic conditions other than diabetes mellitus, like hypertension, bleeding disorders, asthma.
- •and those required steroids.
- •4.Pregnant patients.
- •5.Patients having history of smoking 6.Patients with a history of antibiotic intake in the preceding month.
- •7.Teeth with immature roots.
- •8.Patients not willing to participate in the study.
- •Nondiabetic patients’ exclusion criteria- 1.Radiographic examination showing periapical index score (PAI) of 3-5 2.Teeth with cracks, cusp fractures, subgingival caries and poor periodontal health 3.Patients with systemic conditions 4.Patients taking steroids.
- •5.Pregnant patients.
- •6.Patients having history of smoking.
- •7.Patients with a history of antibiotic intake in the preceding month.
- •8.Teeth with immature roots.
- •9.Patients not willing to participate in the study Intraoperative exclusion criteria: 1.No pulp exposure seen after complete caries excavation 2.Clinical diagnosis changes to pulpal necrosis 3.Bleeding that cannot be controlled within 5- 10 minutes with 2.5% NaOCl wet cotton pellet.
结局指标
主要结局
Primary outcome is to evaluate the clinical and radiographic outcome of full pulpotomy performed in permanent mature mandibular molars indicative of symptomatic irreversible pulpitis in Type 2 diabetes mellitus patients (HbA1c greater or equal then 6.5%) and non diabetic patients (HbA1c less then 6.5%) and compare them.
时间窗: 6month and 12 month
次要结局
- Secondary outcome(1. To evaluate the time taken to achieve hemostasis during full pulpotomy performed in permanent mandibular molars with symptomatic irreversible pulpitis in Type 2 diabetes mellitus patients (HbA1c greater or equal then 6.5%) and non diabetic patients(HbA1c less then 6.5%) and compare them.)
研究者
Dr Jyoti Chauhan
All India Insitute of Medical Sciences, New Delhi