Clinical trial NCT06049589: Therapeutic Application of Coconut Oil in Oral Health
Official title: Therapeutic Application of Coconut Oil in Oral Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Periodontal Inflammation
Periodontal Attachment Loss
Periodontitis
Lead sponsor: Fundacion Clinica Pardinas
Sponsor class: OTHER
Collaborators: name: Universidade da Coruña
name: University Hospital A Coruña
First posted: 2023-09-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Probing depth in mm
timeFrame: At 0 days, 30 days and 60 days
measure: Bleeding on probing in percentage
timeFrame: At 0 days, 30 days and 60 days
measure: Plaque index in percentage
timeFrame: At 0, 30 and 60 days
measure: Volatile compounds in breath in ppm of sulphur compounds
timeFrame: At 0, 30 and 60 days
measure: Type of bacteria present on samples from saliva and crevicular fluid using Illumina SBS (Sequencing by synthesis)
timeFrame: At 0, 30 and 60 days
Secondary outcomes:
measure: Patient perception using Visual Analog Scale
timeFrame: At 0, 30 and 60 days
measure: Tooth color change measured with the VITA score
timeFrame: At 0, 30 and 60 days
Other outcomes:
Locations:
city: A Coruña
country: Spain
facility: Clinica Medico Dental Pardiñas
Study officials:
affiliation: Universidade de A Coruña
name: Simon Pardinas Lopez, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References: