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临床试验/NCT05662475
NCT05662475已完成不适用

Effect of Non-surgical Periodontal Treatment on Visfatin, fetuin-a and Sirtuin 1 Concentrations in Gingival Crevicular Fluid of Patients With Periodontitis and Type 2 Diabetes

Ondokuz Mayıs University2 个研究点 分布在 2 个国家目标入组 66 人开始时间: 2021年11月15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
66
试验地点
2
主要终点
Bleeding on probing index (BPI)

研究概览

简要总结

The aim of this study is to determine the concentrations of Visfatin, Fetuin-A and Sirtuin 1 in the gingival crevicular fluid and clinical periodontal parameters in diabetic and systemically healthy individuals and to determine whether non-surgical periodontal treatment had any effect on these biomarkers and periodontal clinical parameters at the end of a 3-month follow-up period. The hypothesis of our study is that gingival crevicular fluid Visfatin, Fetuin-A and Sirtuin 1 concentrations will change with non-surgical periodontal treatment in type 2 diabetic and systemically healthy individuals and that this change will be associated with diabetes and clinical parameters.

详细描述

Sixty-six patients were divided into six equal groups; group 1: systemically and periodontally healthy individuals, group 2: systemically healthy individuals with periodontitis, group 3: controlled type 2 diabetes and periodontally healthy individuals, group 4: controlled type 2 diabetes and periodontitis, group 5: uncontrolled type 2 diabetes and periodontally healthy individuals, group 6: uncontrolled type 2 diabetes and periodontitis. The study was planned as a randomized, single-blind, parallel design. Periodontal clinical parameters (Silness-Löe plaque index, Löe-Silness gingival index, probing pocket depth, clinical attachment level, bleeding on probing) were recorded clinically and concentrations of visfatin, fetuin-A and sirtuin 1 in gingival crevicular fluid were assessed biochemically. After baseline examinations, periodontal treatment was completed using a nonsurgical periodontal treatment protocol completed in 24 hours. Periodontal clinical parameters and gingival crevicular fluid were recorded at baseline and 3 months after periodontal treatment. Biochemical analysis and statistical evaluation were performed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
31 Years 至 81 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Volunteering to participate in the study
  • To be over 18 years old
  • No periodontal treatment in the last 6 months
  • Being systemically healthy except for type 2 diabetes
  • Not taking medication for any reason except type 2 diabetes
  • HbA1c <7 in controlled Type 2 diabetes group
  • HbA1c ≥7 in uncontrolled Type 2 diabetes group
  • Not smoking or drinking alcohol

排除标准

  • Not volunteering to participate in the study
  • Under 18 years of age
  • Periodontal treatment in the last 6 months
  • Having any systemic disease affecting the periodontal condition
  • Having used local or systemic antibiotics in the last 3 months
  • Use of anti-inflammatory, steroid drugs in the last 3 months
  • Taking vitamin, mineral or antioxidant supplements in the last 3 months
  • Being pregnant or lactating
  • Regular use of mouthwash
  • Smoking or drinking alcohol

结局指标

主要结局

Bleeding on probing index (BPI)

时间窗: Baseline to 3 months after treatment

BPI was increased in all periodontitis patients with or without type 2 diabetes. Type 2 diabetes has no effect on BPI in periodontitis patients. BPI was reduced after NSPT.

Visfatin concentration in GCF

时间窗: Baseline to 3 months after treatment

Visfatin concentrations in GCF were increased in all periodontitis patients. In periodontal healthy patients with Type 2 diabetes visfatin concentrations in GCF were increased. Non-surgical periodontal treatment decreased the concentration of visfatin in GCF.

Gingival crevicular fluid (GCF) quantity

时间窗: Baseline to 3 months after treatment

The amount of gingival crevicular fluid was not affected by periodontal status in patients with Type 2 diabetes.

Plaque index (PI)

时间窗: Baseline to 3 months after treatment

PI was increased in all periodontitis patients with or without type 2 diabetes. Type 2 diabetes has no effect on PI in periodontitis patients. PI was reduced after non-surgical periodontal treatment (NSPT).

Clinical attachment level (CAL)

时间窗: Baseline to 3 months after treatment

CAL was increased in all periodontitis patients with or without type 2 diabetes. Type 2 diabetes has no effect on CAL in periodontitis patients. CAL was reduced after NSPT.

Gingival index (GI)

时间窗: Baseline to 3 months after treatment

GI was increased in all periodontitis patients with or without type 2 diabetes. Type 2 diabetes has no effect on GI in periodontitis patients. GI was reduced after NSPT.

HbA1c level in blood plasma

时间窗: Baseline to 3 months after treatment

NSPT reduced HbA1c levels of patients with type 2 diabetes.

Sirtuin 1 concentration in GCF

时间窗: Baseline to 3 months after treatment

In systemic healthy individuals, periodontitis decreased the concentration of sirtuin 1 in GCF. Type 2 diabetes increased sirtuin 1 concentration in GCF. In controlled type 2 diabetes patients with periodontitis sirtuin 1 concentrations in GCF were increased. In uncontrolled type 2 diabetes patients with periodontitis sirtuin 1 concentrations in GCF were decreased. Non-surgical periodontal treatment increased the concentration of sirtuin 1 in GCF.

Probable pocket depth (PPD)

时间窗: Baseline to 3 months after treatment

PPD was increased in all periodontitis patients with or without type 2 diabetes. Type 2 diabetes has no effect on PPD in periodontitis patients. PPD was reduced after NSPT.

Fetuin-A concentration in GCF

时间窗: Baseline to 3 months after treatment

Fetuin-A concentrations in GCF were decreased in all periodontitis patients. In periodontal healthy patients with Type 2 diabetes fetuin-A concentrations in GCF were increased. Non-surgical periodontal treatment increased the concentration of fetuin-A in GCF.

次要结局

未报告次要终点

研究者

发起方
Ondokuz Mayıs University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Burcu Ozkan Cetinkaya

Professor in Periodontology

Ondokuz Mayıs University

研究点 (2)

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