Coconut Oil for Mouth Sores

Overseen By Marithza Amaya

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Allergy to tree nuts, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6-7 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding virgin coconut oil (VCO) to standard mouth rinses can better prevent oral mucositis, painful mouth sores that can occur during certain cancer treatments. Participants will use either the standard rinses alone or with VCO to determine which is more effective at reducing the severity of these sores. This trial may suit individuals aged 7 to 26 who are about to undergo intense treatment before a stem cell transplant, have no current mouth sores, and can perform the rinse and spit procedure. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot use coconut oil mouth rinses or additional mouthcare regimens not allowed by the study within 30 days before joining.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that virgin coconut oil (VCO) has been used safely for various health purposes. Studies have found that VCO can help reduce swelling and fight germs, which might lower inflammation and prevent infections in the mouth.

Health Canada states that coconut oil is safe to use in the mouth as a protective coating, meaning it can cover and protect surfaces in the mouth. Although information is still being gathered on its ability to prevent mouth sores, coconut oil has been used safely in other health areas.

Based on this information, VCO is generally well-tolerated, with no major reports of problems when used for similar purposes. However, consulting a healthcare provider for personal advice is always recommended. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Virgin coconut oil is unique because it offers a natural and potentially soothing alternative for treating mouth sores, which are often managed with medicated mouthwashes or topical treatments. Researchers are excited about using virgin coconut oil due to its anti-inflammatory and antimicrobial properties, which may help reduce pain and promote healing. Unlike conventional treatments, which can include chemicals or steroids, virgin coconut oil is a natural substance, making it appealing for those seeking a more holistic approach.

What evidence suggests that virgin coconut oil might be an effective treatment for oral mucositis?

Research has shown that virgin coconut oil (VCO) might help prevent painful mouth sores, often caused by treatments like radiation. VCO possesses properties that can reduce swelling and fight germs. One study found that using VCO as a mouth rinse may lower the risk of these sores by calming inflammation and reducing harmful bacteria in the mouth. Another study highlighted VCO's ability to ease pain and prevent infections, making it a promising option for those at risk of mouth sores. In this trial, participants in one arm will receive standard care plus VCO, while another arm will receive standard care alone. Although more research is needed, early findings suggest VCO could be a helpful addition to regular mouth care routines. ^{1 3 4 6 7}

Who Is on the Research Team?

Courtney Huddle, MSN, RDN, CSPCC, LDN

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for pediatric patients aged 7 to 26 years who are about to receive high-dose chemotherapy and have no current mouth sores. They must be able to perform mouth rinses, not have tree nut allergies, and not be using other non-standard oral care regimens or coconut oil rinses recently.

Inclusion Criteria

I am preparing for a stem cell transplant with intensive treatment.

I can care for myself and am up more than 50% of my waking hours.

I, and if applicable, my caregiver, can follow the study's procedures throughout its duration.

Exclusion Criteria

I use special mouthcare products not listed in the standard plan and intend to keep using them.

I had a stem cell transplant within the last 3 months.

I have used coconut oil mouth rinses in the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive either standard of care with the addition of virgin coconut oil mouth rinses or standard of care alone during the conditioning regimen and through Day +45 following transplant or hospital discharge

6-7 weeks

Follow-up

A Safety Follow Up Visit will occur no sooner than 30 days from last study drug treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Virgin Coconut Oil

Trial Overview The study tests if virgin coconut oil (VCO) can prevent mouth sores when added to standard oral care rinses in children receiving intense chemotherapy. The severity of mouth sores with VCO will be compared against those using only the standard treatment.

How Is the Trial Designed?

Group I: Standard of care + virgin coconut oil Experimental Treatment 1 Intervention

Arm A: Standard of care + virgin coconut oil

Group II: Standard of Care Active Control 1 Intervention

Arm B: Standard of care

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Published Research Related to This Trial

The study involved 86 participants and demonstrated that applying Virgin Coconut Oil (VCO) significantly improved skin integrity scores compared to a control group that only received regular repositioning, indicating VCO's efficacy in preventing pressure ulcers.

Regular repositioning combined with VCO application showed a statistically significant difference in preventing skin damage, suggesting that both interventions are effective strategies for pressure ulcer prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Virgin Coconut Oil and Regular Repositioning in Preventing Pressure Ulcers in Children. Andayani, RP., Wahyuni, F., Ausrianti, R., et al.[2023]

A study involving 60 participants found that coconut oil pulling significantly reduced the count of Streptococcus mutans in saliva, similar to the effects of Chlorhexidine mouthwash.

Coconut oil pulling is a natural and safe alternative to Chlorhexidine for maintaining oral hygiene, with no reported side effects, making it a viable preventive therapy for oral health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Coconut Oil pulling on Streptococcus mutans Count in Saliva in Comparison with Chlorhexidine Mouthwash. Kaushik, M., Reddy, P., Sharma, R., et al.[2019]

Virgin coconut oil (VCO) gel has shown potential in promoting the regeneration of periodontal tissue by significantly affecting the expression of inflammatory mediators TNF-α and TGF-β1 in a study involving 30 male Wistar rats with induced periodontitis.

While VCO gel increased the levels of TNF-α and TGF-β1, its effects were not as pronounced as those observed in the positive and negative control groups, suggesting it may be a beneficial alternative to traditional antibiotics in periodontal treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virgin Coconut Oil as a New Concept for Periodontal Tissue Regeneration via Expressions of TNF-&#945; and TGF-&#946;1. Thahir, H., Irawaty Djais, A., Nasir, M., et al.[2022]

Virgin coconut oil (VCO) produced by MARDI demonstrated significant antinociceptive (pain-relieving) effects in various in vivo models, showing dose-dependent activity in tests like the acetic acid-induced writhing test and formalin test.

The VCOs also exhibited anti-inflammatory properties in an acute model (carrageenan-induced paw edema), but not in a chronic inflammation model, suggesting their potential for short-term pain and inflammation relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo antinociceptive and anti-inflammatory activities of dried and fermented processed virgin coconut oil. Zakaria, ZA., Somchit, MN., Mat Jais, AM., et al.[2017]

In a study involving 36 volunteers with gingival inflammation, virgin coconut oil (VCO) oil pulling did not show a significant reduction in harmful oral bacteria compared to baseline, unlike palm oil (PO) which significantly reduced Mutans streptococci counts.

Overall, there was no significant difference in the effectiveness of VCO versus PO in reducing plaque bacteria, suggesting that while PO may have some benefits for oral health, VCO does not provide superior antimicrobial effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microbiological Effects of Virgin Coconut Oil Pulling in Comparison with Palm Oil Pulling as an Adjunctive Oral Hygiene Care for Patients with Gingival Inflammation: A Randomized Controlled Clinical Trial. Siripaiboonpong, N., Matangkasombut, O., Pengcharoen, H., et al.[2022]

A three-week study involving 32 participants showed that daily oil gum massage with sesame, olive, and coconut oils significantly reduced harmful bacteria (Streptococcus mutans and Lactobacillus) and improved oral health indicators like plaque and gingival scores.

While all oils were effective in reducing bacteria and improving oral health, there was no significant difference in efficacy among the oils compared to the chlorhexidine gel, suggesting that these oils can be valuable preventive agents for oral health, especially in low socioeconomic populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of oil gum massage therapy on common pathogenic oral microorganisms - A randomized controlled trial. Singla, N., Acharya, S., Martena, S., et al.[2021]

A pilot study involving 60 adolescents with plaque-induced gingivitis showed that coconut oil pulling significantly reduced plaque and gingival indices over a 30-day period, starting from day 7.

Coconut oil, rich in lauric acid known for its anti-inflammatory and antimicrobial properties, may serve as an effective adjuvant treatment for improving oral hygiene and reducing gingivitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of coconut oil in plaque related gingivitis - A preliminary report. Peedikayil, FC., Sreenivasan, P., Narayanan, A.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05441813

Coconut Oil to Prevent Mouth Sores in Pediatric Patients ... The purpose of this study is to learn if virgin coconut oil (VCO) mouth rinse can help prevent oral mucositis.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7475120/

The effect of oil pulling with coconut oil to improve dental ... The limited evidence suggests that oil pulling with coconut oil may have a beneficial effect on improving oral health and dental hygiene.

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-06522

Virgin Coconut Oil Mouth Rinse for the Prevention of Oral ... VCO mouth rinse has potential anti-inflammatory, anti-microbial and antioxidant activities that may prevent inflammation of the mucosal membranes in the mouth.

4. link.springer.com link.springer.com/article/10.1007/s12663-025-02515-2

Effect of Coconut Oil Pulling and Benzydamine ... Coconut oil pulling exhibited significant antifungal, anti-inflammatory, and analgesic properties, effectively reducing and preventing radiation-induced oral ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11888752/

After Effects of Radiation on the Caries Status of Head and ... Virgin coconut oil may prevent radiation-induced mucositis and oral bacteria. Coconut oil pulling is popular but has little evidence of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7481940/

Coconut Oil as a Novel Approach to Managing Radiation ... Safety and IRB Approval. Coconut oil is approved by Health Canada as an oral coating agent, defined as “substances used to coat a solid formulation in order ...

7. mdpi.com mdpi.com/2039-4713/15/4/126

Virgin Coconut Oil and Its Lauric Acid, Between Anticancer ... VCO has been shown to be beneficial against ulcerative colitis, experimental infertility, inflammatory bowel disease, antibiotic gentamicin toxicity, and oral ...