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

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ClinicalTrials.gov Identifier: NCT04692246
Recruitment Status : Terminated (Due to COVID-19 Pandemic)
First Posted : December 31, 2020
Last Update Posted : December 31, 2020
Sponsor:
Collaborator:
University of Palermo
Information provided by (Responsible Party):
Francisco Mesa, Universidad de Granada

Brief 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.


Condition or disease Intervention/treatment Phase
Periodontitis Other: Plant-based oral rinse Other: Placebo oral rinse Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Essential Oils as Adjutants on the Treatment of Subjects With Periodontitis: Assessment of Metabolic Variables as Effect Modifiers
Actual Study Start Date : November 1, 2019
Actual Primary Completion Date : March 1, 2020
Actual Study Completion Date : March 1, 2020

Arm Intervention/treatment
Experimental: Test Group
Patients that will receive the application of the extract in form of irrigation solutions in the periodontal pockets during regular periodontal treatment. Patients would continue at home during the follow-up period, taking the essential oils in as a rinse twice per day, and as a spray when regular toothbrush could not be performed.
Other: Plant-based oral rinse
Oral rinse enriched with plant-based essential oils.

Placebo Comparator: Control Group
Patients that will follow the same protocol, but using placebo irrigation and a placebo spray at home.
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




Primary Outcome Measures :
  1. Pocket probing depth [ Time Frame: Change from Baseline Pocket probing depth at 3 months ]
    Depth of periodontal pockets present in the teeth of each patient in millimeters (mm) using a periodontal probe (PCPUNC-15)

  2. Pocket probing depth [ Time Frame: 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)

  3. Gingival recession [ Time Frame: Change from Baseline Gingival recession at 3 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)

  4. Gingival recession [ Time Frame: 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)

  5. Bleeding on probing [ Time Frame: Change from Baseline Bleeding on probing at 3 months ]
    Percentage of teeth (%) that showed bleeding during periodontal examination.

  6. Bleeding on probing [ Time Frame: Change from Baseline Bleeding on probing at 6 months ]
    Percentage of teeth (%) that showed bleeding during periodontal examination.

  7. Oral hygiene [ Time Frame: Change from Baseline Visual Plaque Index at 3 months ]
    Percentage of teeth surfaces (4 in each tooth) that showed visible plaque during periodontal examination (Visual Plaque Index).

  8. Oral hygiene [ Time Frame: 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).


Secondary Outcome Measures :
  1. Body weight [ Time Frame: Change from Baseline Body weight at 3 months ]
    Weight of each patient in kilograms (Kg) with a body scale.

  2. Body weight [ Time Frame: Change from Baseline Body weight at 6 months ]
    Weight of each patient in kilograms (Kg) with a body scale.

  3. Body height [ Time Frame: Baseline ]
    Height of each patient in centimeters (cm) with a scale.

  4. Waist circumference [ Time Frame: Change from Baseline Waist circumference at 3 months ]
    Waist abdominal circumference of each patient in centimeters (cm) with a measure tape.

  5. Waist circumference [ Time Frame: Change from Baseline Waist circumference at 6 months ]
    Waist abdominal circumference of each patient in centimeters (cm) with a measure tape.

  6. Systolic Blood pressure [ Time Frame: Change from Baseline Systolic Blood pressure at 3 months ]
    Systolic Blood pressure of each patient in Hg millimeters (Hg mm) measured with a sphygmomanometer.

  7. Systolic Blood pressure [ Time Frame: Change from Baseline Systolic Blood pressure at 6 months ]
    Systolic Blood pressure of each patient in Hg millimeters (Hg mm) measured with a sphygmomanometer.

  8. Diastolic Blood pressure [ Time Frame: Change from Baseline Diastolic Blood pressure at 3 months ]
    Diastolic Blood pressure of each patient in Hg millimeters (Hg mm) measured with a sphygmomanometer.

  9. Diastolic Blood pressure [ Time Frame: Change from Baseline Diastolic Blood pressure at 6 months ]
    Diastolic Blood pressure of each patient in Hg millimeters (Hg mm) measured with a sphygmomanometer.

  10. Glycemia [ Time Frame: Change from Baseline Glycemia at 3 months ]
    Fasting glycemia of each patient in milligrams per deciliter (mg/dL) measured with a glucometer.

  11. Glycemia [ Time Frame: Change from Baseline Glycemia at 6 months ]
    Fasting glycemia of each patient in milligrams per deciliter (mg/dL) measured with a glucometer.

  12. Total cholesterol [ Time Frame: Change from Baseline Total cholesterol at 6 months ]
    Total cholesterol levels of each patient in mg/dL measured in serum samples.

  13. Triglyceride [ Time Frame: Change from Baseline Triglyceride at 6 months ]
    Triglyceride levels of each patient in mg/dL measured in serum samples.

  14. LDL-cholesterol [ Time Frame: Change from Baseline LDL-cholesterol at 6 months ]
    Low-density lipoprotein levels of each patient in mg/dL measured in serum samples.

  15. HDL-cholesterol [ Time Frame: Change from Baseline HDL-cholesterol at 6 months ]
    High-density lipoprotein cholesterol levels of each patient in mg/dL measured in serum samples.


Other Outcome Measures:
  1. Sex [ Time Frame: Baseline ]
    Sex of the patient (male/female)

  2. Age [ Time Frame: Baseline ]
    Age of the patient at baseline examination

  3. Smoking [ Time Frame: Baseline ]
    Smoking habit of each patient in cigarrettes per day.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04692246


Locations
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Spain
University of Granada School of Dentistry
Granada, Spain, 18071
Sponsors and Collaborators
Universidad de Granada
University of Palermo
Investigators
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Principal Investigator: Francisco Mesa, PhD Full Professor
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Responsible Party: Francisco Mesa, Full Professor, Universidad de Granada
ClinicalTrials.gov Identifier: NCT04692246    
Other Study ID Numbers: PON-FSE-2017-1
First Posted: December 31, 2020    Key Record Dates
Last Update Posted: December 31, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Francisco Mesa, Universidad de Granada:
Anti-inflammation
Nutraceuticals
Periodontal therapy
Periodontitis
Additional relevant MeSH terms:
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Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases