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临床试验/NCT01195493
NCT01195493已完成4 期

Clinical and Microbiological Effects of an Essential Oils Solution Used as an Adjunct to Daily Oral Hygiene Practices in Chronic Periodontitis Patients in Supportive Care

University Hospital, Ghent1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2010年3月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
50
试验地点
1
主要终点
Clinical and microbiological effects of an essential oils solution.

研究概览

简要总结

Chronic periodontitis is a common infectious disease characterized by progressive attachment loss and alveolar bone resorption eventually resulting in tooth loss. The ultimate goal of periodontal therapy is to prevent this endpoint. At least when a strict supportive care program is implemented following active therapy, subsequent tooth loss is limited to a mean of about 0.1 per patient per year. In contrast, three to six times as many teeth may be lost if the disease is left untreated.

The objective of supportive care is to prevent disease recurrence, which is accomplished by strict home care and professional plaque control at regular intervals depending on the patient's needs. Evidently, not all patients are optimally compliant in terms of plaque control. Therefore, chemical aids could be administered to supplement mechanical plaque removal.

Essential oils solutions containing menthol, thymol, methyl salicylate and eucalyptol as active agents may be more appropriate to supplement daily home care. Clinical studies have shown an additional anti-plaque and anti-gingivitis effect over mechanical plaque control without relevant side effects in healthy subjects and gingivitis patients.

Recently, significant reductions of periodontopathogens in the subgingival biofilm have been shown in periodontitis patients following subgingival irrigation using an essential oils solution. In addition, mouthrinsing on a daily basis seemed to substantially alter the subgingival microflora towards a less pathogenic one in gingivitis and periodontitis patients. Even though these are interesting findings, they should be considered exploratory since they relate to a small number of patients observed for only two weeks.

The goal of the present study was to thoroughly document the clinical and microbiological effects of an essential oils solution used on a daily basis for 3 months as an adjunct to mechanical plaque control measures in a large number of chronic periodontitis patients in supportive care.

研究设计

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

入排标准

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

入选标准

  • •Presence of at least one 4 mm pocket per quadrant
  • •Patient in maintenance care for at least one year

排除标准

  • •Presence of 7 mm pockets or more
  • •Use of antibiotics within 3 months prior to the study
  • •Patients undergoing orthodontic therapy
  • •Patients wearing removable partial dentures

研究组 & 干预措施

test mouthrinse

Experimental

干预措施: Essential Oils solution (Other)

control group

Active Comparator

干预措施: negative control solution (Other)

结局指标

主要结局

Clinical and microbiological effects of an essential oils solution.

时间窗: at 3 months

Thoroughly document the clinical and microbiological effects of an essential oils solution used on a daily basis for 3 months as an adjunct to mechanical plaque control measures in a large number of chronic periodontitis patients in supportive care. These effects are recorded, at baseline (prior to supportive treatment) and after 3 months (again prior to supportive treatment) by the same calibrated clinician

次要结局

  • Location of the gingival margin in relation to the cement-enamel junction measured to the nearest mm at 6 sites per tooth using a manual probe(at 3 months)
  • Probing Pocket Depth measured to the nearest mm at 6 sites per tooth using a manual probe.(at 3 months)
  • Bleeding on Probing evaluated 15 seconds following pocket probing(at 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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