Therapeutic Application of Coconut Oil in Oral Health

Periodontitis Clinical Trial

Official title:

Therapeutic Application of Coconut Oil in Oral Health

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06049589
• Other study ID #: 001-FCP
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: August 2024

Study information

• Verified date: April 2024
• Source: Fundacion Clinica Pardinas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: August 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammation
• Periodontal Attachment Loss
• Periodontal Diseases
• Periodontal Inflammation
• Periodontitis

Intervention

Dietary Supplement:
• Coconut Oil
Coconut oil rinsing

Drug:
• Chlorhexidine mouthwash
Chlorhexidine rinsing

Other:
• Water mouthwash
Control with water rinsing

Locations

Country	Name	City	State
Spain	Clinica Medico Dental Pardiñas	A Coruña

Sponsors (3)

Lead Sponsor	Collaborator
Fundacion Clinica Pardinas	Universidade da Coruña, University Hospital A Coruña

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probing depth in mm	To evaluate the effect of treatment on probing depth reduction.	At 0 days, 30 days and 60 days
Primary	Bleeding on probing in percentage	To evaluate the effect of treatment on reduction of bleeding on probing	At 0 days, 30 days and 60 days
Primary	Plaque index in percentage	To evaluate the effect of treatment on reduction of plaque accumulation	At 0, 30 and 60 days
Primary	Volatile compounds in breath in ppm of sulphur compounds	To evaluate the effect of treatment on the presence of sulphur compounds present on breath	At 0, 30 and 60 days
Primary	Type of bacteria present on samples from saliva and crevicular fluid using Illumina SBS (Sequencing by synthesis)	To evaluate the effect of treatment on the oral microbiome	At 0, 30 and 60 days
Secondary	Patient perception using Visual Analog Scale	To evaluate patient perception on the use of the mouthrinse in a scale from 1 to 10 for each question.	At 0, 30 and 60 days
Secondary	Tooth color change measured with the VITA score	To evaluate the change on tooth color before and after using the mouthwash.	At 0, 30 and 60 days