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临床试验/NCT07193979
NCT07193979已完成不适用

Relationship Between Diabetes and Periodontal Status and Dental Caries

Afyonkarahisar Health Sciences University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
Periodontal Index (PI) Score

研究概览

简要总结

Diabetes mellitus, one of the major global health problems of the 21st century, is a chronic metabolic disease characterized by dysregulated nutrient metabolism resulting from defects in insulin secretion and action. Patients with diabetes mellitus are more likely to develop chronic periodontitis. A bidirectional relationship between diabetes mellitus and periodontitis has been demonstrated. Dental complications of diabetes mellitus include periodontitis and dental caries. Dental caries, resulting from tooth demineralization, are more prevalent in diabetic individuals than in non-diabetic individuals. For adults, HbA1c levels were defined as <7% ("good" control), HbA1c levels between 7% and 8% as "inadequate" control, and levels above 8% as "poor" control. In the study conducted by the investigators, patients diagnosed with type 2 diabetes mellitus and those diagnosed with periodontitis were grouped according to HbA1C levels, and the relationship between these levels and the stage/degree of periodontitis and the degree of caries was examined. Although studies on periodontal diseases and dental caries among adults with type 2 diabetes mellitus exist in the literature, no study has, as far as is known that classifies HbA1c levels in patients with controlled and uncontrolled diabetes diagnosed with periodontitis and explains the relationship between these groups and the stage/degree of periodontitis and the degree of caries.

详细描述

Mechanisms by which diabetes mellitus affects the periodontium have been reported, including altering host immune, inflammatory, and wound-healing responses, promoting the accumulation of advanced glycation end products, and inducing elevated levels of proinflammatory cytokines. Periodontitis is a common chronic infectious disease that can lead to the destruction of periodontal supporting tissues. Pathologically, a hyperactive inflammatory response contributes to the progression of these two diseases. Diabetes mellitus, in particular, increases the risk of periodontitis by activating immune and inflammatory responses in periodontal tissues. These active responses lead to increased cytokine secretion, increased oxidative damage, and impaired receptor-mediated signaling. All of these events accelerate the breakdown of periodontal connective tissue and alveolar bone resorption, thereby exacerbating periodontitis. Conversely, periodontitis can lead to deranged glycemic control in diabetic patients. Dental complications of diabetes mellitus include periodontitis and dental caries. Dental caries, resulting from tooth demineralization, is more prevalent in diabetic individuals than in non-diabetic individuals. The combination of carbohydrate intake and insulin deficiency leads to hyposalivation and higher salivary glucose levels, both of which contribute to an increased risk of dental caries. Factors that increase the risk of dental caries include decreased plaque microbial flora, decreased buffering and cleansing activities of saliva, decreased salivary flow rate, and decreased calcium levels. Glycemic control can be measured in various ways. For this study, researchers focused on glycated hemoglobin (HbA1c), which represents the average blood glucose levels over the previous 3 months. The study examined the relationship between the severity of periodontitis and the DMFT index according to HgA1C levels in diabetic patients. To our knowledge, no studies in the literature have classified HbA1c levels in patients with and without periodontitis, explaining the relationship between these groups and the stage/degree of periodontitis and the degree of caries. A standard periodontal examination was performed on the volunteers included in the study, and the gingival index (GI) (Loe & Silness, 1963 ), plaque index (PI) (Silness & Loe, 1964 ), probing depth (PD), bleeding on probing (BOP) (Ainamo & Bay, 1975 ), and clinical attachment level (CAL) were determined at six sites for each tooth except the third molars. The Decayed, Missing, and Filled Teeth (DMFT) index, declared by the World Health Organization, is an indicator of caries experience. During the intraoral examination, the total number of teeth and the status of teeth and fillings were recorded. Decayed teeth were examined visually and by radiographs. The numbers of decayed teeth (DT), missing teeth (MT), and filled teeth (FT) were recorded, and the DMFT index was calculated as the sum of DT+MT+FT.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
23 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age between 20 and 65 years Diagnosed with Type 2 Diabetes Mellitus (T2DM) Diagnosed with periodontitis, according to established clinical criteria

排除标准

  • •Diagnosis of Type 1 Diabetes Mellitus Diagnosis of gestational diabetes Presence of physical or mental disorders that may affect participation or evaluation Undergoing chemotherapy or radiotherapy Presence of any systemic disease other than diabetes mellitus Use of systemic antibiotics or other medications in the past 3 months Use of antiparkinsonian, antidepressant, or antipsychotic medications

结局指标

主要结局

Periodontal Index (PI) Score

时间窗: One-time measurement at the beginning of the study

PI will be used to assess periodontal health, scored according to WHO guidelines (Unit of Measure: Millimeters (mm))

Clinical Attachment Loss (CAL)

时间窗: One-time measurement at the beginning of the study

Clinical attachment loss will be measured at six sites per tooth using a periodontal probe (Unit of Measure: Millimeters (mm))

Probing Depth (PD)

时间窗: One-time measurement at the beginning of the study

Probing depth will be measured at six sites per tooth using a periodontal probe.(Millimeters (mm))

Total DMFT Index Score

时间窗: One-time measurement at the beginning of the study

The DMFT index will be calculated by summing the number of decayed (D), missing (M), and filled (F) teeth for each participant, as per WHO guidelines.

次要结局

  • Bleeding on Probing (BOP)(One-time measurement at the beginning of the study)
  • Gingival Index (GI)(One-time measurement at the beginning of the study)
  • Number of Decayed Teeth (D Component of DMFT Index)(One-time measurement at the beginning of the study)
  • Number of Filled Teeth (F Component of DMFT Index)(One-time measurement at the beginning of the study)
  • Number of Missing Teeth (M Component of DMFT Index)(One-time measurement at the beginning of the study)

研究者

发起方
Afyonkarahisar Health Sciences University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kübra Karaçam

assist. prof.

Afyonkarahisar Health Sciences University

研究点 (1)

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