Periodontal DiseasesNCT06049589
Therapeutic Application of Coconut Oil in Oral Health
A study testing Coconut Oil, Chlorhexidine mouthwash and Water mouthwash in people with Periodontal Diseases and Periodontal Inflammation, run by Fundacion Clinica Pardinas at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Periodontal Diseases, Periodontal Inflammation, Periodontal Attachment Loss
- What is being tested?
- Coconut Oil, Chlorhexidine mouthwash and Water mouthwash
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2022to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Periodontal Diseases, Periodontal Inflammation, Periodontal Attachment Loss, Periodontitis
- Being tested
- Coconut Oil, Chlorhexidine mouthwash, Water mouthwash
- Medical subject headings
- Periodontal Diseases, Periodontal Attachment Loss, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coconut OilDietary supplement
Coconut oil rinsing
Chlorhexidine mouthwashDrug
Chlorhexidine rinsing
Water mouthwashOther
Control with water rinsing
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Water mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing depth in mm
To evaluate the effect of treatment on probing depth reduction.
Measured: 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
Measured: At 0 days, 30 days and 60 days
Plaque index in percentage
To evaluate the effect of treatment on reduction of plaque accumulation
Measured: 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
Measured: 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
Measured: At 0, 30 and 60 days
Secondary outcomes (2)
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.
Measured: 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.
Measured: At 0, 30 and 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start1 Nov 2022
- Primary completion31 Dec 2023
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinica Pardinas
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade da Coruña, University Hospital A Coruña
- Responsible party
- Principal investigator, Simón Pardiñas López, Instituto de Investigacion Biomedica de A Coruna
- Investigators
- Simon Pardinas Lopez, DDS, MS, Principal investigator, Universidade de A Coruña
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049589
- Sponsor's protocol ID
- 001-FCP
- Status last verified
- Feb 2025
- First submitted
- 1 Sep 2023
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pardinas Lopez S, Khouly I, Aellos F, Alccayhuaman KA, Diaz Prado SM. Clinical efficacy and patient-reported outcomes of coconut oil as adjunctive periodontitis treatment: triple-blinded pilot randomized trial. BMC Oral Health. 2026 Apr 29;26(1):873. doi: 10.1186/s12903-026-08411-6.
PubMed 42057009
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Application of Coconut Oil in Oral Health
- ClinicalTrials.gov ID
- NCT06049589
- Acronym / sponsor ID
- 001-FCP
- Conditions
- Periodontal Diseases, Periodontal Inflammation, Periodontal Attachment Loss, Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fundacion Clinica PardinasUniversity, hospital or other
- Collaborators
- Universidade da Coruña, University Hospital A Coruña
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 22 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Coconut oil | Experimental | Dietary Supplement: Coconut OilParticipants 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. |
| Chlorhexidine | Active comparator | Drug: Chlorhexidine mouthwashParticipants 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. |
| Water | Placebo comparator | Other: Water mouthwashParticipants 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coconut OilCoconut oil rinsing | Dietary supplement | Coconut oil |
| Chlorhexidine mouthwashChlorhexidine rinsing | Drug | Chlorhexidine |
| Water mouthwashControl with water rinsing | Other | Water |
Primary outcome
Probing depth in mm
Time frame: At 0 days, 30 days and 60 days
To evaluate the effect of treatment on probing depth reduction.
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
Plaque index in percentage
Time frame: At 0, 30 and 60 days
To evaluate the effect of treatment on reduction of plaque accumulation
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
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
2 secondary outcomes
Patient perception using Visual Analog Scale
Time frame: At 0, 30 and 60 days
Tooth color change measured with the VITA score
Time frame: At 0, 30 and 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Derived from this study: PubMed 42057009Pardinas Lopez S, Khouly I, Aellos F, Alccayhuaman KA, Diaz Prado SM. Clinical efficacy and patient-reported outcomes of coconut oil as adjunctive periodontitis treatment: triple-blinded pilot randomized trial. BMC Oral Health. 2026 Apr 29;26(1):873. doi: 10.1186/s12903-026-08411-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Pardinas Lopez, DDS, MS principal investigator
Universidade de A Coruña
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coconut Oil, Chlorhexidine mouthwash and Water mouthwash in people with Periodontal Diseases and Periodontal Inflammation, run by Fundacion Clinica Pardinas at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing depth in mm (time frame: At 0 days, 30 days and 60 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06049589, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025.