跳至主要内容
临床试验/NCT06145685
NCT06145685已完成不适用

Effect of Smoking Cessation on Salivary IL-1β and PGE-2 Levels Following Non-Surgical Periodontal Therapy

October 6 University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年1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
入组人数
40
试验地点
1
主要终点
Interleukin 1 beta (in PG/ml)

研究概览

简要总结

The aim of this study is to evaluate the effect of smoking cessation on inflammatory markers following non-surgical treatment of periodontal disease. This is to assess the period of smoking abstinence needed before any periodontal surgery in order to reverse the negative effects of the reported increased levels of inflammatory markers (IL-1β and PGE2 in this study) associated with smoking on the healing and the periodontium.

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
Single (Care Provider)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients with advanced chronic periodontitis upon clinical examination with clinical attachment loss (CAL) more than 5 mm.
  • •Patients willing to quit smoking to be included in two groups, while patients unwilling to quit smoking to be included in the third group, and the non-smokers as the fourth group.

排除标准

  • •Any systemic illness known to affect the outcome.
  • •Systemic antimicrobial or anti-inflammatory drug therapy within the last 3 months prior to the study.
  • •Patients unable to perform routine oral hygiene procedures.
  • •Patients using other forms of tobacco.

研究组 & 干预措施

Previous smokers - Minimally invasive

Active Comparator

Minimally invasive non-surgical periodontal treatment

干预措施: Minimally invasive non-surgical periodontal therapy (Procedure)

Previous smokers - Conventional

Active Comparator

Conventional non-surgical periodontal treatment

干预措施: Conventional non-surgical periodontal therapy (Procedure)

Smoker

Active Comparator

Conventional non-surgical periodontal treatment

干预措施: Conventional non-surgical periodontal therapy (Procedure)

Non-smoker

Active Comparator

Conventional non-surgical periodontal treatment

干预措施: Conventional non-surgical periodontal therapy (Procedure)

结局指标

主要结局

Interleukin 1 beta (in PG/ml)

时间窗: Baseline and 2 months

Salivary biochemical analysis

Levels of Prostaglandin E2

时间窗: Baseline and 2 months

Salivary biochemical analysis

次要结局

  • Pocket depth (in mm)(Baseline and 9 months)
  • clinical attachment level (in mm)(Baseline and 9 months)
  • Periodontal clinical parameters(Baseline and 9 months)
  • Plaque index (scores)(Baseline and 9 months)
  • bone gain (in mm)(Baseline and 9 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Y Gamal

Professor of Oral Medicine, Periodontology and Oral Diagnosis, Faculty of Dentistry, Ain Shams University. Professor of Periodontology, College of Oral and Dental Surgery, Misr University for Science and Technology.

Ain Shams University

研究点 (1)

Loading locations...

相似试验

Effect of Smoking Cessation on Salivary IL-1β and... | 临床试验