Therapeutic Application of Coconut Oil in Oral Health

• ClinicalTrials.gov Identifier: NCT06049589
• Recruitment Status: Active, not recruiting
• First Posted: September 22, 2023
• Sponsor: Fundacion Clinica Pardinas
• Collaborators: Universidade da Coruña; University Hospital A Coruña
• Information provided by (Responsible Party): Simón Pardiñas López, Instituto de Investigacion Biomedica de A Coruna

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Periodontal Diseases; Periodontal Inflammation; Periodontal Attachment Loss; Periodontitis	Dietary Supplement: Coconut Oil; Drug: Chlorhexidine mouthwash; Other: Water mouthwash	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Therapeutic Application of Coconut Oil in Oral Health
• Actual Study Start Date: November 1, 2022
• Actual Primary Completion Date: December 31, 2023
• Estimated Study Completion Date: August 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Coconut oil; Participants will perform 10-minute vigorous full-mouth rinses once daily after night (2-minute brushing time) brushing. The amount of coconut oil used will be one teaspoon (5 ml). Each participant will be given a container with volume measurement markings. Patients will be provided with the same toothbrush and toothpaste for their dental hygiene 2 times a day. Participants will be asked not to use products containing xylitol, tea, coffee, systemic antibiotics, or topical fluoride during the study. Any participant who violates these rules will be excluded from the study. Reevaluation and sampling will be done after 30 days.	Dietary Supplement: Coconut Oil; Coconut oil rinsing
Active Comparator: Chlorhexidine; Participants will vigorously rinse their entire mouth with Chlorhexidine 0.12% daily after morning (2 minute brushing time) and evening brushing. The amount of chlorhexidine used will be one teaspoon (5 ml). Each participant will be given a container with volume measurement markings. Patients will be provided with the same toothbrush and toothpaste for their dental hygiene 2 times a day. Participants will be asked not to use products containing xylitol, tea, coffee, systemic antibiotics, or topical fluoride during the study. Any participant who violates these rules will be excluded from the study. Reevaluation and sampling will be done after 30 days.	Drug: Chlorhexidine mouthwash; Chlorhexidine rinsing
Placebo Comparator: Water; Participants will vigorously rinse their entire mouth with water daily after morning (2 minute brushing time) and evening brushing. The amount of water used will be one teaspoon (5 ml). Each participant will be given a container with volume measurement markings. Patients will be provided with the same toothbrush and toothpaste for their dental hygiene 2 times a day. Participants will be asked not to use products containing xylitol, tea, coffee, systemic antibiotics, or topical fluoride during the study. Any participant who violates these rules will be excluded from the study. Reevaluation and sampling will be done after 30 days.	Other: Water mouthwash; Control with water rinsing

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Spain

Clinica Medico Dental Pardiñas

A Coruña, Spain, 15003

Sponsors and Collaborators

Fundacion Clinica Pardinas

Universidade da Coruña

University Hospital A Coruña

Investigators

• Principal Investigator: Simon Pardinas Lopez, DDS, MS; Universidade de A Coruña

More Information

• Responsible Party: Simón Pardiñas López, Principal Investigator, Instituto de Investigacion Biomedica de A Coruna
• ClinicalTrials.gov Identifier: NCT06049589
• Other Study ID Numbers: 001-FCP
• First Posted: September 22, 2023
• Last Update Posted: April 26, 2024
• Last Verified: April 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Periodontitis; Periodontal Diseases; Periodontal Attachment Loss; Inflammation; Pathologic Processes; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy; Chlorhexidine; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants