Oral Care Protocol for the Management of Chemotherapy and Radiation Therapy-Induced Oral Mucositis

Oral mucositis (OM) is one of the most debilitating adverse effects in cancer patients
treated with chemotherapy or radiation (RT). Currently, there are no effective therapies or
prevention for mucositis, while several clinical studies have suggested that professional
oral care could effectively reduce the severity of Radiation Therapy or chemotherapy-induced
oral mucositis. Palliative treatment, rather than preventive or curative measures, remains
the standard of care. Evidence-based guidelines do not provide consistent recommendations for
the prevention, treatment and management of oral mucositis.

The investigators hypothesize that a monitored regimen of professional oral hygiene prevents
harmful ecological shifts in the oral cavity, improve oral health and reduce the duration and
severity of Oral Mucositis in cancer patients, consequently improving their overall quality
of life during treatment. Moreover, the investigators hypothesize that the weekly oral
hygiene regimen performed by an oral health professional is more effective in treating and
preventing mucositis than current standard-of-care treatments.

The principal investigator of this project has developed a novel oral care regimen protocol
for the treatment of oral mucositis. The "Oral Mucosa Deterging and Periodontal Debridement"
(OMDP) protocol consists of a regimen of frequent professional oral prophylaxis including
tooth cleaning, tooth polishing and flossing, and the debridement of the periodontium and
deterging of the oral mucosa. This is an intervention that is implemented prior to and
maintained throughout the entire cycle of the radiation or chemoradiation. Co-adjuvant
treatments such as intense fluoride treatments, oral hygiene instructions and palliative
mouth-rinses are also part of the protocol. The hypothesis is that repeated professional
prophylaxis of the oral cavity would protect the healthy oral tissue against infection and
inflammation often associated with severe cases of mucositis, and consequently reduces
mucositis incidence and duration.

Participants in this study would attend approximately 9 study visits over the course of 16-18
weeks, depending on their specific cancer treatment plan. Study participants will be
randomized to receive either the oral health protocol, which they will receive on a weekly
basis, or standard of care oral hygiene instructions and tooth brushing, preformed on a
bi-weekly basis.

Inclusion Criteria:

1. Male and female patient aged 18 years or older;

2. Patients must sign an informed consent before data collection, screening, or
initiation of study procedures;

3. Patients who are scheduled to undergo radiation or chemoradiation treatment for
head/neck cancer;

4. Patients who have a minimum of 6 natural teeth at the time of enrollment.

Exclusion Criteria:

1. Female patients who are pregnant or lactating at the baseline/screening visit;

2. Patient participating in another biomedical/oral health research study that would
interfere with participating in this study;

3. Patient deprived of freedom, under supervision or guardianship;

4. Patient unable to attend to scheduled medical monitoring due to geographical, social
or mental reasons;

5. Immune compromised or other serious medical conditions, regardless of whether the
condition is controlled or not;

6. Patient who requires pre-medication prior to dental treatment;

7. Any patient, in the opinion of the Investigator, who is unable or unlikely to comply
fully with the study requirements or procedures for any reason (e.g. major surgical
resection of intra-oral structures which would prevent oral care intervention,
edentulous, severe periodontal disease, etc).