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Completed

NCT Number: NCT06049589

Therapeutic Application of Coconut Oil in Oral Health

The scientific literature has verified that coconut oil has properties that open perspectives for its application in order to maintain oral health and, in particular, for the treatment of different oral pathologies.

Thus, the purpose of this project is summarized in the following objectives:

1. Determine in vitro the biocompatibility of coconut oil. 2. Determine in vivo the clinical effect of coconut oil as an adjunct treatment for periodontal disease.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinica Medico Dental Pardiñas

A Coruña, 15003, Spain

About this study

Periodontal disease is one of the most prevalent pathologies in humans. In the latest survey on Oral Health in Spain by the Council of Dentists of Spain, it is determined that between 85-94% of the Spanish population over 35 years of age has some problem related to their gums. Severe periodontal diseases, which can lead to tooth loss, affect 15%-20% of middle-aged adults (35-44 years).

One of the most common products used as an antibacterial agent to treat different oral conditions is chlorhexidine and its derivatives. Chlorhexidine exists commercially in different preparations such as mouthwash, toothpaste and gel, among others. Their main drawbacks are that in the long term they stain the teeth and can cause oral lesions, burning sensation and a deterioration in the sensation of taste.

Likewise, various antibiotics, both local and systemic, are used as an adjuvant in the treatment of certain types of gum diseases. Due to the rapid increase in bacterial resistance due to the extensive use of antibiotics, it is important to evaluate alternative antimicrobial agents that can help reduce the use of antibiotics.

Both the coconut and the plant from which this fruit comes are widely used in traditional medicine. Furthermore, the scientific literature on the biological effect of different presentations of this plant (alcoholic extract of coconut shell, coconut water, coconut oil, etc.) has shown, among others, anti-inflammatory activities, analgesic, antioxidant, antifungal, antimicrobial and even antitumor.

There are several hypotheses that suggest that the benefits of using coconut oil can be attributed to the presence of lauric acid, which has the ability to destroy the lipid membrane of microorganisms such as the herpes virus and Gram positive and Gram negative bacteria. Likewise, the viscosity of the oil could inhibit bacterial adhesion and plaque accumulation.

Recent studies describe that oral rinses with coconut oil provide an inhibition in the accumulation of bacterial plaque and plaque-induced gingivitis and a significant reduction of Streptococcus mutans in saliva, suggesting that coconut oil can have a preventive therapeutic application, with fewer adverse effects and lower cost for the maintenance of oral health and treatment of various oral pathologies such as Gingivitis and Periodontitis.

Therefore, the purpose of this study is to determine the effectiveness of coconut oil as an adjunct treatment for periodontal disease.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients of legal age (18 years) affected by periodontitis with the ability to read, understand and sign the informed consent after having explained the nature of the study, with a willingness to follow protocol requirements
  • Diagnosed with periodontal disease stages II, III and IV and grades B and C
  • Minimum of 16 natural teeth

Exclusion criteria

  • Patients who have been treated with antibiotics in the last 4 weeks and who are currently being treated with antibiotics.
  • Patients who regularly use gum or candies with xylitol, coconut or coconut derivatives.
  • Patients who have received dental cleaning within the last 6 months.
  • Pregnant and breastfeeding patients,
  • Patients with allergies to coconut, coconut-derived products and chlorhexidine
  • Patients with uncontrolled diabetes, uncontrolled high blood pressure, bleeding disorders, liver or kidney disease, heart disease, active cancer, active infectious diseases (other than periodontitis) and patients with a history of local irradiation therapy in the head/neck area.

Treatment and study plan

Coconut oil

Dietary Supplement

Coconut oil rinsing

Chlorhexidine mouthwash

Drug

Chlorhexidine rinsing

Water Mouthwash

Other

Control with water rinsing

Primary outcomes

  1. Probing depth in mm

    Time frame: At 0 days, 30 days and 60 days

    To evaluate the effect of treatment on probing depth reduction.

  2. Bleeding on probing in percentage

    Time frame: At 0 days, 30 days and 60 days

    To evaluate the effect of treatment on reduction of bleeding on probing

  3. Plaque index in percentage

    Time frame: At 0, 30 and 60 days

    To evaluate the effect of treatment on reduction of plaque accumulation

  4. Volatile compounds in breath in ppm of sulphur compounds

    Time frame: At 0, 30 and 60 days

    To evaluate the effect of treatment on the presence of sulphur compounds present on breath

  5. Type of bacteria present on samples from saliva and crevicular fluid using Illumina SBS (Sequencing by synthesis)

    Time frame: At 0, 30 and 60 days

    To evaluate the effect of treatment on the oral microbiome

Secondary outcomes

  1. Patient perception using Visual Analog Scale

    Time frame: At 0, 30 and 60 days

    To evaluate patient perception on the use of the mouthrinse in a scale from 1 to 10 for each question.

  2. Tooth color change measured with the VITA score

    Time frame: At 0, 30 and 60 days

    To evaluate the change on tooth color before and after using the mouthwash.

Sponsors and collaborators

Lead sponsor

Fundacion Clinica Pardinas

Other

Collaborators

  • Universidade da Coruña
  • University Hospital A Coruña

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Sep 22, 2023
Registry last updated
Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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