Therapeutic Application of Coconut Oil in Oral Health

NCT06049589 | Completed DMC

• 1 other identifier: 001-FCP
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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. 1.Determine in vitro the biocompatibility of coconut oil.
2. 2.Determine in vivo the clinical effect of coconut oil as an adjunct treatment for periodontal disease.

Conditions

Periodontal Diseases; Periodontal Inflammation; Periodontal Attachment Loss; Periodontitis

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Patient perception using Visual Analog Scale

  At 0, 30 and 60 days

• Tooth color change measured with the VITA score

  At 0, 30 and 60 days

Study Arms (3)

Coconut oil

EXPERIMENTAL

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

Chlorhexidine

ACTIVE COMPARATOR

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

Water

PLACEBO COMPARATOR

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

Interventions

Coconut Oil DIETARY_SUPPLEMENT

Coconut oil rinsing

Coconut oil

Chlorhexidine mouthwash DRUG

Chlorhexidine rinsing

Chlorhexidine

Water mouthwash OTHER

Control with water rinsing

Water

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion Clinica Pardinas: lead
• Universidade da Coruña: collaborator
• University Hospital A Coruña: collaborator

Study Sites (1)

Clinica Medico Dental Pardiñas

A Coruña, A Coruña, 15003, Spain

Location

MeSH Terms

Conditions

Periodontal Diseases; Periodontal Attachment Loss; Periodontitis

Interventions

Coconut Oil

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Intervention Hierarchy (Ancestors)

Dietary Fats; Fats; Lipids; Plant Oils; Oils

Study Officials

• Simon Pardinas Lopez, DDS, MS

  Universidade de A Coruña

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 22, 2023
• Study Start: November 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: August 31, 2024
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)