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临床试验/NCT04355988
NCT04355988已完成不适用

Influence of Glycemic Levels on Healing of Periapical Lesions in Type 2 Diabetic Patients Following Primary Nonsurgical Root Canal Therapy

Postgraduate Institute of Dental Sciences Rohtak2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2018年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
2
主要终点
Clinical Success

研究概览

简要总结

Increased incidence of peri-radicular lesions have been reported in diabetic patients which has been implicated due to compromised immune response. Much research has been done on the pathogenesis and progression of this lesion in diabetic patients. Although there are few studies which focus on healing of periradicular lesions after nonsurgical root canal treatment. There is a lacunae in literature which highlights peri-radicular healing after nonsurgical root canal treatment in relation to Glycaemic control in diabetic patients measured in terms of HbA1c levels.

详细描述

Diabetes mellitus is defined as a group of metabolic disorders characterized by chronic hyperglycemia with disturbances in carbohydrates, fat, and protein metabolism resulting from defects in insulin secretion, insulin action, or both. The effects of diabetes mellitus include long-term damage, dysfunction and failure of various organs: eyes, kidneys, nerves, heart, and blood vessels . Diabetes Mellitus is broadly classified into two types. Diabetes due to reduced insulin secretion from islet cells of pancreas is are known as type 1 and Diabetes due to combination of insulin resistance , reduced or increased insulin secretion are known as type 2.

One of the main detrimental effects of diabetes is its downregulation of immune system. It affects the immune cell function, up-regulates cytokines from monocytes or leukocytes and down-regulates the various growth factors predisposing to chronic inflammation, progressive tissue breakdown and reduced tissue repair capacity . So body becomes increasingly susceptible to infections and worsens if the blood glucose levels are not brought back to normal range .Oral symptoms of uncontrolled diabetes may comprise a plethora of conditions, such as dry mouth, tooth decay, periodontal diseases, delayed wound healing, and increased incidence of infection following surgery.

Diabetes mellitus inhibits collagen fibril formation and also interferes with collagen cross-linking and may impair degradation of matrix proteins and subsequent tissue remodeling , leading to poor wound healing in diabetics. Poor wound healing is similar in diabetic dental pulp.

Apical periodontitis is a chronic inflammatory lesion of the periapical region caused due to release of infectious products from the infected root canal system in the case of necrotic non vital pulp. It is characterized by periapical bone loss which does not heal unless the irritating agent is removed.

Thus, pro-inflammatory status and impaired immune response associated with systemic diseases can affect the reparative response of the dental pulp and periapical healing.Periapical immune response localizes the infection within the confines of the root canal system and prevents its systemic dissemination. In the host immune system, neutrophil is the first defense line when pathogens invade. Diabetes mellitus seriously impairs the function and bactericidal activity of neutrophils.

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
None

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Clinical Success

时间窗: Baseline to one year

Absence of signs and symptoms Absence of tenderness to percussion Tooth mobility of grade 1 or less Absence of associated soft tissue swelling or tenderness to palpation Attachment loss of less than 5mm . Two experienced observers with no knowledge of the treatment protocol will independently examine the immediate post obturation and follow up radiographs, mounted side by side, under controlled conditions. The treatment is considered successful only when both clinical and radiographic criteria are met. The worst outcome of an individual root decide the overall outcome for the tooth. In the event of disagreement, the two observers will meet to discuss their findings and came to an agreement.

次要结局

  • Radiographic success(Baseline to one year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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