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临床试验/NCT06191497
NCT06191497进行中(未招募)不适用

The Effect of Nicotine Exposure on Periodontal Tissues After Non- Surgical Periodontal Therapy With and Without the Use of a Chlorhexidine-based Antiseptic in Patients With Periodontitis

University of Rijeka1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年3月14日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
60
试验地点
1
主要终点
Full mouth plaque score

研究概览

简要总结

The aim of this study is to evaluate whether the use of a chlorhexidine based oral antiseptic will improve clinical results of non-surgical periodontal therapy (NSPT) in smokers with periodontitis.

A randomized controlled clinical trial will be carried out on 60 subjects with periodontitis- 30 smokers and 30 non-smokers. All subjects will be clinically examined. The following periodontal indices will be measured: Full mouth plaque score (FMPS), Full mouth bleeding score (FMBS), Pocket probing depth (PPD), Clinical attachment level (CAL), Gingival recession (GR) and Tooth mobility (TM). All subjects will have NSPT carried out. Half of the subjects in each group will use a 0.12% chlorhexidine based mouth rinse twice a day during 15 days. Clinical examination will be repeated 8 weeks after NSPT and compared.

详细描述

A total of 60 subject will be recruited among patients seeking periodontal treatment at the Department. All subjects will have periodontitis diagnosed according to the criteria outlined in the 2017 Classification of Periodontal and Peri-implant Diseases and Conditions. The subjects will be divided into two groups based on smoking status. The first group of 30 subjects will consist of cigarettes smokers and the second group of 30 non- smokers. All the subjects in the first group smoke for a minimum of 3 years and at least 10 cigarettes a day. Patients smoking e-cigarettes, tobacco heating systems, cigarettes without filter and occasional smokers will be excluded from the study. Moreover, minors, pregnant woman, patients with systemic diseases affecting periodontal tissues, immunodeficient patients, patients who used antibiotics in the previous six months, patients with orthodontic appliances or retainers and patients who previously had periodontal therapy or were in supportive therapy will be excluded from the study. A randomization plan based on sex (male; female), age (</> 50 years), nicotine exposure (smoker; non-smoker) and intervention (with/ without CHX) will be made using an online randomization software. All subjects will undergo a clinical examination before and 8 weeks after non-surgical periodontal therapy. Clinical examination will include all teeth except third molars and will be carried out using a millimeter graduated PCP-15 UNC periodontal probe (Hu-Friedy, Chicago, USA). The following periodontal indices will be measured: Full mouth plaque score (FMPS), Full mouth bleeding score (FMBS), Pocket probing depth (PPD), Clinical attachment level (CAL), Gingival recession (GR) and Tooth mobility (TM).

All subjects will have non-surgical periodontal therapy carried out according to the principles of Guided biofilm therapy (GBT) (EMS Dental, Geneve, Switzerland) using AIRFLOW Prophylaxis Master ultrasonic instruments (EMS Dental, Geneve, Switzerland) and Gracey curettes (Hu- Friedy, Chicago, USA). Moreover, half of the subjects in each group, 15 smokers and 15 non-smokers, will use a 0.12% chlorhexidine-digluconate based mouthwash (Curasept ADS 212, Curasept SpA, Saronno, Italy) twice a day for one minute during a period of 15 days. Subsequently, four subgroups of 15 subjects will be formed- non-smokers (NS), non-smokers who used CHX (NS-CHX), smokers (S) and smokers who used CHX (S-CHX).

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

入选标准

  • patients with periodontitis smokers and non smokers.

排除标准

  • minors, pregnant woman, patients with systemic diseases affecting periodontal tissues, immunodeficient patients, patients who used antibiotics in the previous six months, patients with orthodontic appliances or retainers and patients who previously had periodontal therapy or were in supportive therapy
  • Patients smoking e-cigarettes, tobacco heating systems, cigarettes without filter and occasional smokers

研究组 & 干预措施

Non-smokers

Active Comparator

15 non-smoking subjects with diagnosed periodontitis. All of them underwent NSPT

干预措施: non surgical periodontal therapy (Procedure)

Non-smokers+ CHX

Experimental

15 non-smoking subjects with diagnosed periodontitis. All of them underwent NSPT and used 0.12% chlorhexidine mouthwash for 15 days after therapy

干预措施: non surgical periodontal therapy (Procedure)

Non-smokers+ CHX

Experimental

15 non-smoking subjects with diagnosed periodontitis. All of them underwent NSPT and used 0.12% chlorhexidine mouthwash for 15 days after therapy

干预措施: Chlorhexidine mouthwash (Drug)

Smokers

Active Comparator

15 cigarette smoking subjects with diagnosed periodontitis. All of them underwent NSPT

干预措施: non surgical periodontal therapy (Procedure)

Smokers + CHX

Experimental

15 cigarette smoking subjects with diagnosed periodontitis. All of them underwent NSPT and used 0.12% chlorhexidine mouthwash for 15 days after therapy

干预措施: non surgical periodontal therapy (Procedure)

Smokers + CHX

Experimental

15 cigarette smoking subjects with diagnosed periodontitis. All of them underwent NSPT and used 0.12% chlorhexidine mouthwash for 15 days after therapy

干预措施: Chlorhexidine mouthwash (Drug)

结局指标

主要结局

Full mouth plaque score

时间窗: 8 weeks

plaque accumulation

Full mouth bleeding score

时间窗: 8 weeks

gingival bleeding

Pocket depth

时间窗: 8 weeks

periodontal pocket depth in mm

Clinical attachment level

时间窗: 8 weeks

clinical attachment loss in mm

Gingival recession

时间窗: 8 weeks

gingival recession in mm

Tooth mobility

时间窗: 8 weeks

tooth mobility- Miller class

次要结局

未报告次要终点

研究者

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

Aleksandar Pupovac

Assistant, Department of Periodontology

University of Rijeka

研究点 (1)

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