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Therapeutic Application of Coconut Oil in Oral Health

Primary Purpose

Periodontal Diseases, Periodontal Inflammation, Periodontal Attachment Loss

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Coconut Oil
Chlorhexidine mouthwash
Water mouthwash
Sponsored by
Fundacion Clinica Pardinas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Diseases

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinica Medico Dental PardiñasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Coconut oil

Chlorhexidine

Water

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Probing depth in mm
To evaluate the effect of treatment on probing depth reduction.
Bleeding on probing in percentage
To evaluate the effect of treatment on reduction of bleeding on probing
Plaque index in percentage
To evaluate the effect of treatment on reduction of plaque accumulation
Volatile compounds in breath in ppm of sulphur compounds
To evaluate the effect of treatment on the presence of sulphur compounds present on breath
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

Secondary Outcome Measures

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.
Tooth color change measured with the VITA score
To evaluate the change on tooth color before and after using the mouthwash.

Full Information

First Posted
September 1, 2023
Last Updated
September 15, 2023
Sponsor
Fundacion Clinica Pardinas
Collaborators
Universidade da Coruña, University Hospital A Coruña
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1. Study Identification

Unique Protocol Identification Number
NCT06049589
Brief Title
Therapeutic Application of Coconut Oil in Oral Health
Official Title
Therapeutic Application of Coconut Oil in Oral Health
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundacion Clinica Pardinas
Collaborators
Universidade da Coruña, University Hospital A Coruña

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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: 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases, Periodontal Inflammation, Periodontal Attachment Loss, Periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Coconut oil
Arm Type
Experimental
Arm Description
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.
Arm Title
Chlorhexidine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Water
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Coconut Oil
Intervention Description
Coconut oil rinsing
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine mouthwash
Intervention Description
Chlorhexidine rinsing
Intervention Type
Other
Intervention Name(s)
Water mouthwash
Intervention Description
Control with water rinsing
Primary Outcome Measure Information:
Title
Probing depth in mm
Description
To evaluate the effect of treatment on probing depth reduction.
Time Frame
At 0 days, 30 days and 60 days
Title
Bleeding on probing in percentage
Description
To evaluate the effect of treatment on reduction of bleeding on probing
Time Frame
At 0 days, 30 days and 60 days
Title
Plaque index in percentage
Description
To evaluate the effect of treatment on reduction of plaque accumulation
Time Frame
At 0, 30 and 60 days
Title
Volatile compounds in breath in ppm of sulphur compounds
Description
To evaluate the effect of treatment on the presence of sulphur compounds present on breath
Time Frame
At 0, 30 and 60 days
Title
Type of bacteria present on samples from saliva and crevicular fluid using Illumina SBS (Sequencing by synthesis)
Description
To evaluate the effect of treatment on the oral microbiome
Time Frame
At 0, 30 and 60 days
Secondary Outcome Measure Information:
Title
Patient perception using Visual Analog Scale
Description
To evaluate patient perception on the use of the mouthrinse in a scale from 1 to 10 for each question.
Time Frame
At 0, 30 and 60 days
Title
Tooth color change measured with the VITA score
Description
To evaluate the change on tooth color before and after using the mouthwash.
Time Frame
At 0, 30 and 60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Simon Pardinas Lopez, DDS, MS
Phone
0034636630427
Email
s.pardinas@clinicapardinas.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Pardinas Lopez, DDS, MS
Organizational Affiliation
Universidade de A Coruña
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinica Medico Dental Pardiñas
City
A Coruña
ZIP/Postal Code
15003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simon Pardinas Lopez, DDS, MS
Phone
0034636630427
Email
s.pardinas@clinicapardinas.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Therapeutic Application of Coconut Oil in Oral Health

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