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

NCT04692246 | Terminated

• 1 other identifier: PON-FSE-2017-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Periodontitis

Keywords

Anti-inflammation; Nutraceuticals; Periodontal therapy; Periodontitis

Outcome Measures

Primary Outcomes (8)

• Pocket probing depth

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

  Change from Baseline Pocket probing depth at 3 months

• Pocket probing depth

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

  Change from Baseline Pocket probing depth at 6 months

• Gingival recession

  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)

  Change from Baseline Gingival recession at 3 months

• Gingival recession

  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)

  Change from Baseline Gingival recession at 6 months

• Bleeding on probing

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

  Change from Baseline Bleeding on probing at 3 months

• Bleeding on probing

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

  Change from Baseline Bleeding on probing at 6 months

• Oral hygiene

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

  Change from Baseline Visual Plaque Index at 3 months

• Oral hygiene

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

  Change from Baseline Visual Plaque Index at 6 months

Secondary Outcomes (15)

• Body weight

  Change from Baseline Body weight at 3 months

• Body weight

  Change from Baseline Body weight at 6 months

• Body height

  Baseline

• Waist circumference

  Change from Baseline Waist circumference at 3 months

• Waist circumference

  Change from Baseline Waist circumference at 6 months

Other Outcomes (3)

• Sex

  Baseline

• Age

  Baseline

• Smoking

  Baseline

Study Arms (2)

Test Group

EXPERIMENTAL

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

Control Group

PLACEBO COMPARATOR

Patients that will follow the same protocol, but using placebo irrigation and a placebo spray at home.

Other: Placebo oral rinse

Interventions

Plant-based oral rinse OTHER

Oral rinse enriched with plant-based essential oils.

Test Group

Placebo oral rinse OTHER

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

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Granada: lead
• University of Palermo: collaborator

Study Sites (1)

University of Granada School of Dentistry

Granada, 18071, Spain

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Francisco Mesa, PhD

  Full Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 31, 2020
• Study Start: November 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: December 31, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)