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临床试验/NCT04692246
NCT04692246终止不适用

Effect of Essential Oils as Adjutants on the Treatment of Subjects With Periodontitis: Assessment of Metabolic Variables as Effect Modifiers

Universidad de Granada2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
60
试验地点
2
主要终点
Pocket probing depth

研究概览

简要总结

Periodontitis, an infectious disease that affects the tooth-supporting tissues and shows a wide range of clinical, microbiological, and immunological manifestations, is associated with and probably caused by dynamic interaction among infectious agents, host immune responses, hazardous environmental exposure and genetic propensity. Bacteria are necessary for the disease to appear, but are not sufficient and do not account for all cases of periodontitis. According to one survey in the USA, chronic periodontitis affects approximately 46% of the adult population, with an even higher prevalence among the elderly. This prevalence refers to the cohort of young adults according to the WHO, with ages ranging from 35 to 44 years. Forms of periodontitis that appear at younger ages (before the age of 30 years), and that have other characteristics in addition to age, are known as aggressive periodontitis. The prevalence of this disorder ranges from 0.2% in Caucasians to 2.6% in Afro-Americans. The microbiota of the human oral mucosa together with other anatomical locations in the body constitute the human microbiome. The equilibrium between these organisms and the host response plays a fundamental role in human biology, both in health maintenance and in the appearance of disease. Unfavorable alterations in the composition of the microbiota are termed dysbiosis.

Antiseptics and antibiotics such as Chlorhexidine or Metronidazole, are delivered locally as an adjunct to scaling and root planing procedures, in order to eradicate the subgingival microbes, hence creating a healthy subgingival environment. However, the results presented in the literature are inconclusive. There is a need for further clinical trials with strict methodological criteria for allowing a more precise assessment of the efficacy of local antimicrobials in the treatment of chronic periodontitis.

Recently, there has been renewed interest in the application of natural products. Several natural products and herbs have claimed to have better properties and less side effects than chemical agents for irrigation. The use of natural extracts and essential oils as an irrigation agent for ultrasonic instrumentation has shown to promote slight adjunctive effect compared to chlorhexidine or water. In other study, natural extract showed a greater improvement compared to controls in patients with a more severe degree of periodontitis. However, in other studies this pocket reduction and clinical attachment gain were no significant when compared to water. Natural products have also been tested in forms of oral spray, and have shown to be effective against common oral pathogens without significant cytotoxicity in an in vitro study. Thus, it has the potential to prevent the infections and may serve as adjunctive treatment to conventional therapy. They claim to have the same or even more anti-microbial effect and anti-inflammatory effect without adding any chemicals. But still there is no adequate scientific evidence to support this hypothesis.

This study aims to test the effect as an adjutant to therapy of a nutraceutical composed of several plant extracts in patients with periodontitis and different levels of risk for metabolic syndrome. Specifically:

  1. The response of periodontal clinical variables to non-surgical periodontal treatment in patients treated with the extract, compared to controls.
  2. The effect on local inflammatory markers, in patients treated with the extract compared to controls.
  3. The modifier effect of metabolic syndrome-related variables in the treatment outcomes of the patients treated with the extract compared to controls.

Hypothesis:

The application of the plant extract would act as an anti-inflammatory agent, contributing to better treatment outcomes of periodontitis, in terms of clinical and biochemical variables.

详细描述

METHODOLOGY

Study design Randomized, controlled, double-blinded clinical trial.

Study unit/population Subjects with diagnosis of periodontitis according to the joint EFP/AAP 2018 criteria for the case definition of periodontitis.

Inclusion criteria Patients attended in the University of Granada School of Dentistry (Granada, Spain) Signing of a written consent.

Exclusion criteria Age under 18 years, received periodontal treatment in the last year, anti-microbial therapy in the previous 3 months, multiple pregnancy and the presence of neoplastic or severe infectious diseases.

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
Quadruple (Participant, Care Provider, 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

  • Patients attended in the University of Granada School of Dentistry (Granada, Spain)
  • Accepting to be enrolled in the study and signing of a written consent.

排除标准

  • Age under 18 years,
  • Received periodontal treatment in the last year,
  • Anti-microbial therapy in the previous 3 months
  • Allergies
  • Multiple pregnancy
  • Presence of neoplastic or severe infectious diseases.

结局指标

主要结局

Pocket probing depth

时间窗: Change from Baseline Pocket probing depth at 6 months

Depth of periodontal pockets present in the teeth of each patient in millimeters (mm) using a periodontal probe (PCPUNC-15)

Gingival recession

时间窗: Change from Baseline Gingival recession at 6 months

Distance from the gingival margin to the cemento-enamel junction in the teeth of each patient in millimeters (mm) using a periodontal probe (PCPUNC-15)

Oral hygiene

时间窗: Change from Baseline Visual Plaque Index at 6 months

Percentage of teeth surfaces (4 in each tooth) that showed visible plaque during periodontal examination (Visual Plaque Index).

Bleeding on probing

时间窗: Change from Baseline Bleeding on probing at 6 months

Percentage of teeth (%) that showed bleeding during periodontal examination.

次要结局

  • Body height(Baseline)
  • Systolic Blood pressure(Change from Baseline Systolic Blood pressure at 6 months)
  • Triglyceride(Change from Baseline Triglyceride at 6 months)
  • Body weight(Change from Baseline Body weight at 6 months)
  • Total cholesterol(Change from Baseline Total cholesterol at 6 months)
  • HDL-cholesterol(Change from Baseline HDL-cholesterol at 6 months)
  • Waist circumference(Change from Baseline Waist circumference at 6 months)
  • LDL-cholesterol(Change from Baseline LDL-cholesterol at 6 months)
  • Diastolic Blood pressure(Change from Baseline Diastolic Blood pressure at 6 months)
  • Glycemia(Change from Baseline Glycemia at 6 months)

研究者

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

Francisco Mesa

Full Professor

Universidad de Granada

研究点 (2)

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