At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Oral Care Protocol for the Management of Chemotherapy and Radiation Therapy-Induced Oral Mucositis
In Brief
A clinical study evaluating Oral Mucosa Deterging and Periodontal Debridement (OMDP), Standard of Care Oral Hygiene Instructions, and 2 other interventions for Oral Mucositis and Oral Cancer. Completed, enrolled 19 participants across 1 site.
Detailed Summary
The purpose of this study is to determine the effects of a novel oral care protocol on the severity and pain of oral mucositis in patients receiving radiation and/or chemotherapy for head and neck cancers. The secondary objectives are to characterize the microbiome associated with oral mucositis, measure salivary proinflammatory cytokines, and evaluate other clinical indicators of the intervention. Participants will be enrolled prior to beginning radiation and/or chemotherapy, and will be randomized to receive either the oral health protocol or standard of care oral hygiene.
Study Details
Timeline
Interventions
OMDP consists of a regimen of frequent professional oral prophylaxis including tooth cleaning, tooth polishing and flossing, and the cleaning of the periodontum and oral mucosa. This is an intervention that is implemented prior to and maintained throughout the entire cycle of the radiation or chemoradiation.
Subjects assigned to this intervention will receive standard of care oral hygiene instructions, including in-person instruction and materials to reference at home. Subjects will also have their teeth brushed and flossed bi-weekly by a dental professional.
An ultrasonic dental scaler will be used to clean the teeth
Non-alcoholic chlorhexidine will be used as part of the OMDP protocol