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临床试验/NCT02946801
NCT02946801Unknown4 期

Antiplaque Effect of Essential Oils and 0.2% Chlorhexidine on an in Situ Model of Oral Biofilm Growth. A Randomized Clinical Trial

University of Santiago de Compostela0 个研究点目标入组 20 人开始时间: 2016年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
20
主要终点
Percentage of bacterial viability

研究概览

简要总结

The accumulation and maturation of oral biofilm in the gingival margin is widely recognised to be the primary aetiological factor in the development of chronic gingivitis. Based on this association, the current treatment of gingivitis is focused on biofilm disruption, which will normally include mechanical processes, both professionally and at home. However, for patients, it is not easy to achieve a proper level of plaque control. The efficient plaque control techniques are very time consuming and require a special motivation and skills for their optimum use. It was at this point where mouthwashes become important, due to the fact that they include diverse types of antimicrobial agents to complement the results of mechanical oral hygiene measures.

The essential oils have been presented as a realiable alternative to the "gold Standard" (Chlorhexidine). However, it use has been limited clinically due to their alcohol contain. Some years ago, a new alternative without alcohol has been launched to the market. This formulation has not been already deeply tested specific antiplaque studies in which the structure of the biofilm remained intact.

The aim of this study was to evaluate the in situ antiplaque effect of 2 antimicrobial agents (based on an essential oils formulation with and without alcohol) in the short term with a posterior analysis on "non-destructured" biofilm with Confocal Laser Scanning Microscope combined with fluorescence staining.

研究设计

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

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

  • Systemically healthy adults.
  • Minimum of 24 permanent teeth.
  • No gingivitis (Community Periodontal Index score = 0).
  • No periodontitis (Community Periodontal Index score = 0).
  • Absence of untreated caries.

排除标准

  • Smoker or former smoker.
  • Presence of dental prostheses.
  • Presence of orthodontic devices
  • Antibiotic treatment or routine use of oral antiseptics in the previous 3 months.
  • Presence of any systemic disease that could alter the production or composition of saliva.

研究组 & 干预措施

Essential oils mouthwash

Active Comparator

20 ml rinses for 30 seconds with essential oils/2 times daily (1/0/1).

干预措施: Essential oils (Drug)

essential oils without mouthwash

Experimental

20 mL rinses for 30 seconds with essential oils without alcohol/2 times daily (1/0/1)

干预措施: Essential oils without alcohol (Drug)

sterile water mouthwash

Sham Comparator

20 mL rinses for 30 seconds with sterile water/2 times daily (1/0/1)

干预措施: Sterile water (Drug)

结局指标

主要结局

Percentage of bacterial viability

时间窗: 96 hours after the volunteer has worn the splints with the disks

次要结局

  • Thickness in microns(96 hours after the volunteer has worn the splints with the disks)
  • Percentage of area covered by the biofilm(96 hours after the volunteer has worn the splints with the disks)

研究者

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

Inmaculada Tomas

Senior Lecturer

University of Santiago de Compostela

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