跳至主要内容
临床试验/NCT04733196
NCT04733196已完成不适用

Randomised Controlled Trial Comparing the Clinical Effectiveness of 5 Mouthwashes Based on Essential Oils, Chlorhexidine, Hydrogen Peroxide and Prebiotic, in Gingivitis Treatment

Plovdiv Medical University1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2020年10月1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
已完成
发起方
入组人数
180
试验地点
1
主要终点
Change from baseline bleeding index at 21 day.

研究概览

简要总结

The aim of the present study is to evaluate the efficacy of 5 mouthwashes, based on different ingredients, in the treatment of generalised gingivitis.

详细描述

The present clinical study aims to investigate the clinical efficacy of 5 mouthwashes based on different active substances. The study include 180 patients divided into 6 groups of 30 patients, each group rinse with one of the following mouthwashes - mouthwash based on essential oils (menthol, thymol and eucalyptus), mouthwash based on essential oils (menthol, thymol and eucalyptus) and 0.12% chlorhexidine, mouthwash based on 0,8 % hydrogen peroxide, mouthwash based on prebiotic, water based on 0.2% chlorhexidine, placebo mouthwash. Inclusion criteria are: generalized gingival inflammation, plaque index of Turesky, 1970 > 1.95, gingival index of Loe & Silness, 1963 > 0.95, no systemic diseases, no systemic medication, lack of severely damaged teeth, no large fillings, no orthodontic treatment. Patients are motivated and instructed to maintain proper and optimal personal oral hygiene. All participants undergo professional mechanical plaque removal. After instrumentation participants are instructed to rinse with 15 ml mouthwash 2 times a day for 21 days. Researchers control the amount of mouthwash used by giving a new bottle of mouthwash with the required amount for 1 patient for 1 week at the beginning of each week and taking back the bottle from the previous week. During the study period, patients are monitored on days 14 and 21, examining plaque index of Turesky, 1970, gingival index of Loe & Silness, 1963, bleeding index of Ainamo & Bay, 1975, side effects like staining, burning itching, oral lesions. At the end of the study (day 21), patients complete a questionnaire.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Care Provider)

盲法说明

Participants and providers did not have information about the ingredients in the mouthwashes.

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

  • Plaque Index (Turesky, 1970) > 1,95;
  • Gingival Index (Loe & Silness, 1963) > 0,95;
  • Bleeding Index (Animo & Bay, 1975) > 30 %;
  • no systemic diseases;
  • no systemic medication.

排除标准

  • severely destroyed teeth;
  • non correct obturation class II and V;
  • orthodontic treatment;
  • third molars.

研究组 & 干预措施

Essential oils

Experimental

Mouthwash based on essential oils - menthol, eucalypts oil, thymol, alcohol

干预措施: Essential oils (Drug)

Essential oils in combination with clorhexidine 0,12%

Experimental

Mouthwash based on essential oils - mentol, eucalypt oil, thymol, alcohol, and 0,12% chlorhexidine

干预措施: Essential oils in combination with chlorhexidine 0,12% (Drug)

Placebo mouthwash

Placebo Comparator

Water, colorant, sweetener

干预措施: Placebo mouthwash (Drug)

Clorhexidine 0,20% in combination with aroma oils

Experimental

Mouthwash based on 0,20% chorhexidine without alcohol in combination with aroma oils of rose and lavender

干预措施: Chlorhexidine 0,20 % in combination with aroma oils (Drug)

Prebiotic

Experimental

Mouthwash based on prebiotic

干预措施: Prebiotic (Drug)

Hydrogen peroxide

Experimental

Mouthwash based on 0,8% hydrogen peroxide in combination with menthol and eucalypts oil

干预措施: Hydrogen peroxide 0,8 % (Drug)

结局指标

主要结局

Change from baseline bleeding index at 21 day.

时间窗: 21 days

Recording the bleeding index of Ainamo\&Bay, 1975. The index reports the presence or absence of bleeding on probing in 4 sites around every tooth. It is calculated in % for the whole dentition.

次要结局

  • Change from baseline gingival index at 21 day.(21 days)
  • Change from baseline oral hygiene index at 21 day.(21 days)

研究者

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

Blagovesta Yaneva

Principle investigator

Plovdiv Medical University

研究点 (1)

Loading locations...

相似试验