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

Summary

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.

Conditions

• Periodontitis

Interventions

OTHER

Plant-based oral rinse

Oral rinse enriched with plant-based essential oils.

OTHER

Placebo oral rinse

Oral rinse with the exact characteristics in terms of colour and odour of the plant-based one, but without the essential oils aimed to test in this study

Sponsors & Collaborators

• University of Palermo

  collaborator OTHER

• Universidad de Granada

  lead OTHER

Principal Investigators

• Francisco Mesa, PhD · Full Professor

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-11-01

Primary Completion

2020-03-01

Completion

2020-03-01

Countries

• Spain

Study Locations