Therapeutic Application of Coconut Oil in Oral Health

Study Overview
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Brief Summary
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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: Determine in vitro the biocompatibility of coconut oil. Determine in vivo the clinical effect of coconut oil as an adjunct treatment for periodontal disease.

Detailed Description
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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.

Official Title
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Therapeutic Application of Coconut Oil in Oral Health

Conditions
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Periodontal Diseases, Periodontal Inflammation, Periodontal Attachment Loss, Periodontitis

Intervention / Treatment
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* Dietary Supplement: Coconut Oil
* Drug: Chlorhexidine mouthwash
* Other: Water mouthwash


Participation Criteria
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Eligibility Criteria
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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 Minimum of 16 natural teeth At least four zones of probing depth of more than 4 mm. 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 periodontal treatment in the last 6 months. Pregnant patients, Patients with allergies to coconut and coconut-derived products Patients with a history of diabetes, liver or kidney disease, heart disease or other serious medical conditions or infectious diseases.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coconut oil<br>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<br>* Coconut oil rinsing<br>|
| Active Comparator: Chlorhexidine<br>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<br>* Chlorhexidine rinsing<br>|
| Placebo Comparator: Water<br>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<br>* Control with water rinsing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing depth in mm | To evaluate the effect of treatment on probing depth reduction. | At 0 days, 30 days and 60 days | 
| 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 | 
| Plaque index in percentage | To evaluate the effect of treatment on reduction of plaque accumulation | At 0, 30 and 60 days | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |