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临床试验/NCT06326073
NCT06326073已完成不适用

Evaluation of the GCF Periostin, IL-17A and IL-17E Levels of Smoking and Non-smoking Periodontitis Patients Received Periodontal Treatment: Short-term Follow-up Study

Ondokuz Mayıs University2 个研究点 分布在 2 个国家目标入组 44 人开始时间: 2019年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
44
试验地点
2
主要终点
Evaluation of IL-17E levels

研究概览

简要总结

It was aimed to evaluate the changes in the levels of Periostin, IL-17A and IL-17E cytokines in the gingival crevicular fluid (GCF) of periodontitis patients which non-surgical (Phase I) periodontal treatment applied to and their interactions with smoking. The study included systemic healthy smokers(SP)(n:11) and non-smokers(P)(n:11) with periodontitis, smokers (SS)(n:11) and non-smokers(S)(n:11) with periodontal healthy individuals Phase I periodontal treatment was applied to the groups with periodontitis. Before treatment (day 0), clinical measurements evaluating periodontal status were recorded and GCF samples were collected. GCF samples were collected from the same tooth regions on the 15th and 30th days after treatment and clinical measurements were repeated. GCF Periostin, IL-17A and IL-17E levels were determined by ELISA method. All data were evaluated statistically.

详细描述

The SH and H groups' patients were instructed to visit for routine controls without receiving any periodontal treatment. However, after the GCF sampling, patients in the SP and P groups received Non-surgical periodontal treatment(NSPT) included detailed oral hygiene instruction and reinforcement in conjunction with scaling and root planning as a full mouth debridement protocol in a single session They were instructed to refrain from using any chemicals, including mouthwash, to remove plaque.

The periodontitis patients received a follow-up call on the 15th and 30th days following treatment. The GCF sampling procedure was first repeated on the teeth from which a previous GCF sample had been taken. Then, values for the clinical examination parameters (PI, GI, BOP, PD, and CAL) were once again measured and recorded. Daily plaque care efficacy or deficiency was checked and/or reinforced at every recall. All these procedures were performed by a single investigator.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • generalized stage 3 periodontitis or periodontally healthy;
  • smoker ((≥10 cigarettes/day for >5 years) or nonsmoker (never smoked in their lifetime);
  • not have received any periodontal treatment in the last 6 months, took any antibiotics, anti-inflammatory drugs regularly and for female subjects, not to be pregnant, lactating, or menopause.

排除标准

  • Under 18 years of age
  • Those with a systemic disease
  • Cancer patients, those with a history of chemotherapy and radiotherapy
  • Pregnant and breastfeeding women
  • Those who smoke less than 10 cigarettes a day and those who quit smoking
  • Having received orthodontic treatment in the last 6 months
  • Using antibiotics, anti-inflammatory or any medication in the last 6 months
  • Those who do not consent voluntarily

研究组 & 干预措施

Group I: SP

Experimental

smokers with periodontitis

干预措施: Non Surgical Periodontal Treatment (Procedure)

Group II: P

Experimental

non-smokers with periodontitis

干预措施: Non Surgical Periodontal Treatment (Procedure)

Group III: SH

No Intervention

smokers with periodontal healthy individuals

Group IV: H

No Intervention

non-smokers with periodontal healthy individuals

结局指标

主要结局

Evaluation of IL-17E levels

时间窗: 0-15-30 days

The effect of non-surgical periodontal treatment in gingival crevicular fluid IL-17E levels

Evaluation of IL-17A levels

时间窗: 0-15-30 days

The effect of non-surgical periodontal treatment in gingival crevicular fluid IL-17A levels

Evaluation of Periostin levels

时间窗: 0-15-30 days

The effect of non-surgical periodontal treatment in gingival crevicular fluid periostin levels

次要结局

  • Interaction Between Smoking and GCF Periostin, IL17A, IL17E levels(0-15-30 days)

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

Sule Ozdogan

Research Assistant

Ondokuz Mayıs University

研究点 (2)

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