Coconut Oil for Mouth Sores

Recruiting in Palo Alto (17 mi)

Overseen by Courtney Huddle, MSN, RDN, CSPCC, LDN

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Allergy to tree nuts, others

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial is testing if a mouth rinse made from virgin coconut oil can help prevent painful mouth sores in young patients receiving intense treatment. The coconut oil is thought to help by calming and reducing inflammation in the mouth.

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.

What data supports the effectiveness of the treatment Virgin Coconut Oil Mouth Rinse for mouth sores?

Virgin coconut oil has antibacterial and anti-inflammatory properties, which have been shown to help with oral health issues like gingivitis and periodontal inflammation. Additionally, its use in oil pulling has demonstrated antimicrobial effects, suggesting it may be beneficial for treating mouth sores. ^{1 2 3 4 5}

Is virgin coconut oil safe for use in humans?

Virgin coconut oil is generally considered safe for use in humans, as it has been used in studies for oral health and skin care without reported safety concerns. It has antibacterial, anti-inflammatory, and antioxidant properties, which contribute to its safety profile. ^{1 2 3 4 6}

How does coconut oil differ from other treatments for mouth sores?

Coconut oil is unique because it contains lauric acid, which has anti-inflammatory and antimicrobial properties, making it potentially beneficial for oral health. Unlike standard treatments, coconut oil is used in a traditional practice called oil pulling, where the oil is swished in the mouth, offering a natural alternative to chemical-based mouthwashes. ^{1 2 3 5 7}

Research Team

Courtney Huddle, MSN, RDN, CSPCC, LDN

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Virgin Coconut Oil (Other)

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.

Participant Groups

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+

Dr. L. Ebony Boulware

Wake Forest University Health Sciences

Chief Medical Officer since 2022

MD from Duke University School of Medicine, MPH from Johns Hopkins Bloomberg School of Public Health

Dr. Julie Ann Freischlag

Wake Forest University Health Sciences

Chief Executive Officer since 2020

BS from University of Illinois, MD from Rush University

Findings from Research

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]

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]

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]

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 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]

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]

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]

References

1. India 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. [2022]

2. United States 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. [2022]

3. Nigeria pubmed.ncbi.nlm.nih.gov

Effect of coconut oil in plaque related gingivitis - A preliminary report. [2023]

4. Malaysia pubmed.ncbi.nlm.nih.gov

Effectiveness of Virgin Coconut Oil and Regular Repositioning in Preventing Pressure Ulcers in Children. [2023]

5. India pubmed.ncbi.nlm.nih.gov

Effect of oil gum massage therapy on common pathogenic oral microorganisms - A randomized controlled trial. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

In vivo antinociceptive and anti-inflammatory activities of dried and fermented processed virgin coconut oil. [2017]

7. India pubmed.ncbi.nlm.nih.gov

The Effect of Coconut Oil pulling on Streptococcus mutans Count in Saliva in Comparison with Chlorhexidine Mouthwash. [2019]