Comparative Evaluation of Periodontal Status among Prediabetic Diabetic AND Non-Diabetic Subjects
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- The severity of periodontal disease, typically assessed using clinical parameters such as probing depth (PD)and clinical attachment loss (CAL). This would involve comparing the mean PD and CAL scores among prediabetic, diabetic, and non-diabetic groups.
研究概览
简要总结
Periodontal diseases are multi-agent infections caused by a number of anaerobic bacteria living on the tooth surface. Lipopolysaccharide and microbial agents in gingival tissues cause primary and permanent inflammation and subsequent increased levels of proinflammatory cytokine followed by the destruction of tooth supporting structures. Diabetes mellitus is a common metabolic disease characterized by hyperglycemia and impaired carbohydrate, protein, and lipid metabolism Moreover, numerous studies suggest that the risk of developing TYPE 2 diabetes mellitus is 5-15 times higher in prediabetic patients compared to in people with normal glucose levels. Prediabetes is defined as a disorder of altered glucose metabolism, which does not conclude the formal definition of diabetes but deliberates an increased risk of progression to diabetes and/or vascular disease. The objective of the study includes, to assess the periodontal status of prediabetic subjects, to assess the periodontal status of diabetic subjects, to assess the periodontal status of non-diabetic subjects and to compare the periodontal status between the groups. The study design is cross sectional study, it will be conducted at Department of Periodontology, Yenepoya dental college. Periodontal parameters will be measured from 48 subjects who volunteer to participate in the study. The data will be collected from the three different groups: Group1: Prediabetic, Group 2: Diabetic, Group 3: Non-diabetic. The following clinical parameters will be assessed: 1.Silness and Loe Plaque index (PI) 2. Loe and Silness Gingival Index (GI) 3. Probing depth 4.Clinical attachment level 5.Marginal bone loss. Descriptive measures like mean and standard deviation will be used to estimate the plaque index, gingival index and periodontal pocket depth. One way ANOVA will be used to test the difference. Karl pearson correlation coefficient will be used to estimate the correlation between them.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 25.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Individual with medically diagnosed prediabetes (HbA1c levels between 5.7% and 6.4%) [11]
- •Individuals with medically diagnosed TYPE 2 diabetes mellitus (HbA1c levels ≥ 6.5%) [11]
- •Nondiabetic controls (HbA1c levels <5.7%) [11]
- •Age-25 to 60 years.
- •Volunteers who are willing to participate in the study.
- •Subjects with minimum of 14 teeth will be included in the study.
排除标准
- •Patients with self-reported systemic diseases such as acquired immune deficiency syndrome, Cardiovascular disorders, hepatic disorders and renal disorders.
- •Use of antibiotics and/or steroids within the past 90 days.
- •Patients who had undergone periodontal therapy within the past 90 days.
- •Habitual alcohol and tobacco use.
- •Pregnancy and/or lactation.
结局指标
主要结局
The severity of periodontal disease, typically assessed using clinical parameters such as probing depth (PD)and clinical attachment loss (CAL). This would involve comparing the mean PD and CAL scores among prediabetic, diabetic, and non-diabetic groups.
时间窗: baseline assessment
次要结局
- glycemic control measure , oral hygiene indices & radiographic assessment(baseline assesment)
研究者
Dr Mohamed Nawfal
Yenepoya Dental College