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Mouthwash makeover: can a dental cleanup beat Radiation's painful side effect?

NCT ID NCT03843554

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a special oral care routine (dental cleaning and mouth treatment) could reduce severe mouth sores in people getting radiation for head and neck cancer. About 60 adults were planned to join, but the study was stopped early. The goal was to see if this approach works better than standard toothbrushing to ease pain and help patients eat.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

60 people

The number who actually took part.

Started

Sep 2019

Finished

Aug 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Currently enrolling subjects receiving intensity-modulated radiation therapy (IMRT), with or without chemotherapy. Subject Inclusion Criteria To participate in this study, an individual must meet all the following criteria: 1. 18 years of age or older; 2. Able and willing to provide informed consent prior to initiation of study procedures; 3. Scheduled to undergo radiation or chemoradiation treatment for head/neck cancer; 4. Presents with at least one of nine areas of the oral or oropharyngeal mucosa (i.e., upper lip, lower lip, right cheek, left cheek, right ventral and lateral tongue, left ventral and lateral tongue, floor of the mouth, and soft palate) expected to receive at least 5000 cGy of RT. Patients with cancer located outside of the oral cavity will be included when at least 5000 cGy of RT will be administered to the oral cavity in addition to the RT targeted at the primary cancer site. 5. Presents with a minimum of 6 natural teeth. Subject Exclusion Criteria An individual who meets any of the following criteria will be excluded from participation in this study: 1. Pregnant or lactating at the baseline/screening visit; 2. Participating in another oral health interventional research study at any point during their participation in this trial; 3. Receiving induction chemotherapy or concurrent radiation therapy with cetuximab; 4. Reports current use of antifungal or antibiotic at the time of enrollment; 5. Presents with immunocompromised status (defined as an absolute neutrophil count (ANC) of less than 1000); 6. Presents with any of the following conditions, which based on American Dental and American College of Cardiology guidelines, require antibiotic prophylaxis prior to dental treatment: 1. prosthetic cardiac valves, including transcatheter-implanted prostheses and homografts; 2. prosthetic material used for cardiac valve repair, such as annuloplasty rings and chords; 3. a history of infective endocarditis; 4. a cardiac transplant with valve regurgitation due to a structurally abnormal valve; 5. the following congenital (present from birth) heart disease: unrepaired cyanotic congenital heart disease, including palliative shunts and conduits; or any repaired congenital heart defect with residual shunts or valvular regurgitation at the site of or adjacent to the site of a prosthetic patch or a prosthetic device; 7. Presents with cardiovascular implantable electronic devices (CIEDs) such as pacemakers, and implantable cardioverter-defibrillators; unless, a) in the opinion of the investigator, the OMDP protocol can be performed with hand scalers (and not with an ultrasonic device as per protocol) or upon consult with the treating cardiologist, it is determined that the ultrasonic device can be safely used; 8. Presents with severe periodontal disease for which treatment cannot be completed prior to the start of radiation/chemoradiation (at the discretion of the investigator); 9. Had surgery as part of cancer treatment and is not sufficiently healed to comply with study requirements prior to RT initiation; 10. In the opinion of the investigator, is unable or unlikely to comply fully with the study requirements or procedures for any reason (e.g. cognitive or physical impairment).

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Conditions

The condition(s) this trial relates to.

head and neck cancer Head and Neck Neoplasms stomatitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.