Clinical trial

Therapeutic Application of Coconut Oil in Oral Health

Name
001-FCP
Description
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.
Trial arms
Trial start
2022-11-01
Estimated PCD
2023-12-31
Trial end
2024-08-01
Status
Active (not recruiting)
Treatment
Coconut Oil
Coconut oil rinsing
Arms:
Coconut oil
Chlorhexidine mouthwash
Chlorhexidine rinsing
Arms:
Chlorhexidine
Water mouthwash
Control with water rinsing
Arms:
Water
Size
30
Primary endpoint
Probing depth in mm
At 0 days, 30 days and 60 days
Bleeding on probing in percentage
At 0 days, 30 days and 60 days
Plaque index in percentage
At 0, 30 and 60 days
Volatile compounds in breath in ppm of sulphur compounds
At 0, 30 and 60 days
Type of bacteria present on samples from saliva and crevicular fluid using Illumina SBS (Sequencing by synthesis)
At 0, 30 and 60 days
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'FACTORIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}
Updated at
2024-04-26

1 organization

1 product

4 indications

Indication
Periodontitis
Indication
periodontitis