Assessment of long-term effects of non-surgical periodontal therapy with and without adjunctive laser treatment on periodontal status, glycemic control and systemic inflammation in patients with type 2 diabetes mellitus and chronic periodontitis: a randomized controlled clinical trial in a Goan population
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Reduction in clinical periodontal parameters
研究概览
简要总结
Study aims to assess the effects of scaling and root planing (SRP) with and without adjunctive use of laser application on periodontal status, glycemic status and systemic inflammation in patients with chronic periodontitis and type II diabetes mellitus.
OBJECTIVES:
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To investigate the effect of periodontal therapy on glycemic control in patients with chronic periodontitis with type II diabetes mellitus.
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To determine the effect of periodontal therapy on systemic inflammation in patients with chronic periodontitis with type II diabetes mellitus.
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To assess and compare the glycemic control and systemic inflammation with and without periodontal therapy in patients with chronic periodontitis and type II diabetes mellitus.
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To determine whether adjunctive use of diode laser application with or without antimicrobial photodynamic therapy improves periodontal parameters, glycemic control and systemic inflammation in patients with chronic periodontitis and type II diabetes mellitus.
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To compare the effects of periodontal therapy with scaling and root planing (SRP) alone with that of combination of SRP and diode laser application or antimicrobial photodynamic therapy on periodontal parameters, glycemic status and systemic inflammation in patients with chronic periodontitis and type II diabetes mellitus.
Patients will be divided into four groups:
Group I: No intervention (control group) (n=20)
Group II: Scaling and root planing (SRP) (n= 20)
Group III: Scaling and root planing (SRP) + diode laser application (n=20)
Group IV: Scaling and root planing (SRP) + antimicrobial photodynamic therapy (n= 20)
Periodontal parameters such as bleeding on probing, gingival index, plaque index, pocket probing depth will be recorded for each patient at baseline (for Group I) and at baseline and at the end of 6 months and 12 months (for groups II, III, IV).
Glycated hemoglobin level will be determined and serum interleukin-! level will be evaluated by ELISA technique using Human Interleukin-1 Elisa kit at baseline and after 6 months and 12 months of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 35.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients between 35 and 70 years of age with confirmed diagnosis of type II diabetes mellitus and generalized chronic periodontitis with 20 or more teeth remaining.
- •Periodontal pocket depth of 5 mm or more with each quadrant having atleast 3 teeth.
排除标准
- •Pregnant/lactating women.
- •Patients who were on antibiotic therapy in the previous six months.
- •Patients who had undertaken any periodontal therapy in past 6 months.
- •Patients with any autoimmune disorders Alcoholics.
结局指标
主要结局
Reduction in clinical periodontal parameters
时间窗: Baseline, 6 months, 12 months
Reduction in glycated hemoglobin level
时间窗: Baseline, 6 months, 12 months
Reduction in serum interleukin-1 level
时间窗: Baseline, 6 months, 12 months
次要结局
未报告次要终点
研究者
Dr SANDEEP ANANT LAWANDE
Goa Dental College and Hospital