Clinical trial · Interventional
Oral Care Protocol for the Management of Chemotherapy and Radiation Therapy-Induced Oral Mucositis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
| Oral Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chlorhexidine | Other | — | UNRESOLVED |
| Dental scaling, ultrasonic | Procedure | — | UNRESOLVED |
| Oral Mucosa Deterging and Periodontal Debridement (OMDP) | Procedure | — | UNRESOLVED |
| Standard of Care Oral Hygiene Instructions | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- OMDP Group
- description
- Subjects randomized to this group will attend weekly visits and receive a full dental cleaning, as well as have their gums/tongue cleaned by a dental professional. Subjects will also receive standard of care oral hygiene instructions.
- interventionNames
- Procedure: Oral Mucosa Deterging and Periodontal Debridement (OMDP)
- Procedure: Dental scaling, ultrasonic
- Other: Chlorhexidine
- type
- OTHER
- label
- Control Group
- description
- Subjects assigned to the control group will receive standard of care oral health instructions and will come for bi-weekly treatment visits where they will have their teeth cleaned (brushed) by a dental professional.
- interventionNames
- Procedure: Standard of Care Oral Hygiene Instructions
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available