Cleansing Device for Scalp Conditions

Overseen By Ronda Farah, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Non-English speaking, Pregnancy, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The objective of this study is to evaluate an improvement of scalp health after the use of an investigational off-label WaterPik and brush device aimed to massage and cleanse the scalp.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment Off-brand Waterpik®, Waterpik, Oral irrigator, Dental water jet for scalp conditions?

Research on oral irrigators, like Waterpik, shows they are effective in reducing plaque and improving gum health, which suggests they might also help in cleansing and improving scalp conditions by removing debris and promoting cleanliness. ^{1 2 3 4 5}

Is the cleansing device for scalp conditions safe for humans?

Research on water flossers (oral irrigators) shows they have been used safely for over 50 years, with studies supporting their safety and no evidence of harmful effects on gums or teeth. ^{1 2 4 6 7}

How is the Waterpik treatment different from other treatments for scalp conditions?

The Waterpik treatment is unique because it uses a high-pressure water jet to cleanse the scalp, which is different from traditional topical treatments or medications. This method, originally designed for oral care, may offer a novel way to remove debris and improve scalp health through mechanical action rather than chemical means. ^{1 2 3 7 8}

Research Team

Maria K Hordinsky

Principal Investigator

University of Minnesota Medical School Department of Dermatology

Ronda Farah, MD

Principal Investigator

University of Minnesota Medical School Department of Dermatology

Eligibility Criteria

This trial is for individuals with scalp conditions like eczema, dandruff, or hair loss. Participants must be evaluated by a dermatologist and use two forms of contraception if they are women who can have children. Non-English speakers, pregnant or lactating women, and those planning pregnancy during the study cannot join.

Inclusion Criteria

You are using a hormone-releasing intrauterine device.

I am currently practicing sexual abstinence.

I use birth control that contains only progestogen.

Exclusion Criteria

Current clinical condition that, in the opinion of the site investigator, would interfere with adherence to study requirements

Exclusion related to pregnancy, lactation, or plans to become pregnant over the course of the study (based on self-report from the participant)

Non-English speaking

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one or three treatments with the investigational WaterPik and brush device

4 weeks

1-3 visits (in-person)

Follow-up

Participants are monitored for changes in erythema, scalp flaking, and sensory assessment scores

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Off-brand Waterpik®

Trial Overview The trial tests an off-brand Waterpik device that uses ultrasonic technology to massage and cleanse the scalp. It aims to see if this improves scalp health in people with various scalp conditions.

Participant Groups

Group I: Seborrheic Dermatitis with one treatment Experimental Treatment 1 Intervention

Participants with seborrheic dermatitis disease who will receive one treatment with the device and complete one in-person follow-up.

Group II: Seborrheic Dermatitis and three treatments Experimental Treatment 1 Intervention

Participants with seborrheic dermatitis who will receive three treatments with the device and complete one in-person follow-up.

Group III: Healthy Scalp and three treatments Experimental Treatment 1 Intervention

Participants with healthy scalps who will receive three treatments with the device and complete one in-person follow-up.

Group IV: Healthy Scalp and one treatment Experimental Treatment 1 Intervention

Participants with healthy scalps who will receive one treatment with the device and complete one in-person follow-up.

Group V: Hair loss disease and three treatments Experimental Treatment 1 Intervention

Participants with hair loss disease who will receive three treatments with the device and complete one in-person follow-up.

Group VI: Hair loss disease and one treatment Experimental Treatment 1 Intervention

Participants with hair loss disease who will receive one treatment with the device and complete one in-person follow-up.

Group VII: Dandruff and three treatments Experimental Treatment 1 Intervention

Participants with dandruff who will receive three treatments with the device and complete one in-person follow-up.

Group VIII: Dandruff and one treatment Experimental Treatment 1 Intervention

Participants with dandruff who will receive one treatment with the device and complete one in-person follow-up.

Off-brand Waterpik® is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Waterpik for:

• Oral hygiene
• Gingivitis prevention
• Plaque removal

Approved in European Union as Waterpik for:

• Oral hygiene
• Gingivitis prevention
• Plaque removal

Approved in Canada as Waterpik for:

• Oral hygiene
• Gingivitis prevention
• Plaque removal

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Findings from Research

The dental water jet, developed in the late 1950s, has been extensively studied for its effectiveness in improving oral health, particularly with the Waterpik model being the most researched.

This article aims to equip dental professionals with evidence-based insights on the benefits and expected outcomes of using dental water jets, helping them make informed decisions for patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The dental water jet: a product ahead of its time. Ciancio, SG.[2022]

The Braun Oral-B OxyJet Oral Irrigator, when used alongside manual brushing, is safe and effectively reduces plaque and improves gingival health in individuals with mild-to-moderate gingivitis, as shown in an 8-week study with 64 participants.

Significant reductions in plaque and gingival inflammation were observed at various points during the study, although the differences between the irrigator group and the manual brushing-only group did not always reach statistical significance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, clinical evaluation of the safety and efficacy of a novel oral irrigator. Frascella, JA., Fernández, P., Gilbert, RD., et al.[2010]

In a study involving 35 participants, a novel oral water irrigator removed about 40.7% of plaque, which is significantly less effective than the 71.6% removal achieved by a conventional electric toothbrush.

However, the oral irrigator caused fewer gingival abrasions compared to the electric toothbrush, suggesting it may be a safer option for maintaining gum health while cleaning teeth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plaque removing capacity of a novel high pressure water irrigator. Eberhard, J., Damm, S., Freitag, S., et al.[2010]

In a study involving 45 volunteers with gingivitis, the use of an oral irrigator with a subgingival tip did not show any significant clinical benefits in reducing gingivitis compared to standard oral hygiene education alone over a 3-month period.

All groups, including those using the irrigator and those using an herbal mouth rinse, experienced improvements in plaque and gingival indices, but there were no statistically significant differences between the groups, indicating that professional oral care education was the key factor in improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does professional preventive care benefit from additional subgingival irrigation? Ernst, CP., Pittrof, M., Fürstenfelder, S., et al.[2018]

In a study involving 38 patients, both mechanical brushing and oral irrigation significantly reduced biofilm and improved oral tissue health, as indicated by lower plaque and gingival indices, probing depth, and bleeding on probing.

There was no significant difference in effectiveness or patient satisfaction between mechanical brushing and oral irrigation, suggesting that both methods are equally effective for maintaining oral hygiene in patients with implant-supported prostheses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Brushing Associated With Oral Irrigation in Maintenance of Peri-Implant Tissues and Overdentures: Clinical Parameters and Patient Satisfaction. Salles, MM., de Cássia Oliveira, V., Macedo, AP., et al.[2021]

Water flossers have been proven safe and effective for over 50 years, positively impacting oral health by reducing plaque, bleeding, and gingivitis.

Extensive research has shown that water flossers do not harm the attachment of gum tissue or pocket depth, countering claims of potential negative effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of a water flosser: a literature review. Jolkovsky, DL., Lyle, DM.[2016]

The HydraBrush Oral Health System (OHS) was found to be more effective than rinsing alone with a powered toothbrush in delivering a solution to the bottom of 5-6 mm periodontal pockets, as shown by a significant visual increase in solution presence (p=0.0001).

Both the OHS and the Sonicare Elite 7800 toothbrush were safe and well-accepted by patients, indicating that the new device could be a beneficial tool for improving oral health without compromising patient comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Penetration of fluids into periodontal pockets using a powered toothbrush/irrigator device. Brackett, MG., Drisko, CL., Thompson, AL., et al.[2013]

In a study of 90 participants with gingivitis, using an oral irrigator (WaterPik®) alongside a toothbrush significantly reduced gingival inflammation and dental plaque compared to using a toothbrush alone, with improvements noted at 4, 8, and 12 weeks.

The oral irrigator was found to be safe, with no significant adverse effects reported, although some transient gingival bleeding was observed; overall, self-reported pain and sensitivity were similar between the two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy and Safety of Oral Irrigator on the Control of Dental Plaque and Gingivitis: A Randomized, Single-Blind, Parallel-Group Clinical Trial. Ren, X., He, J., Cheng, R., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

The dental water jet: a product ahead of its time. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A randomized, clinical evaluation of the safety and efficacy of a novel oral irrigator. [2010]

3. United States pubmed.ncbi.nlm.nih.gov

Plaque removing capacity of a novel high pressure water irrigator. [2010]

4. Germany pubmed.ncbi.nlm.nih.gov

Does professional preventive care benefit from additional subgingival irrigation? [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Brushing Associated With Oral Irrigation in Maintenance of Peri-Implant Tissues and Overdentures: Clinical Parameters and Patient Satisfaction. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Safety of a water flosser: a literature review. [2016]

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

Penetration of fluids into periodontal pockets using a powered toothbrush/irrigator device. [2013]

8. Switzerland pubmed.ncbi.nlm.nih.gov

The Efficacy and Safety of Oral Irrigator on the Control of Dental Plaque and Gingivitis: A Randomized, Single-Blind, Parallel-Group Clinical Trial. [2023]