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| ID | Type | Description | Link |
|---|---|---|---|
| 03-21-01A | Other Identifier | Atrium Health |
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Radiation therapy to treat cancer may cause a dry mouth from damage to salivary glands which may increase the risk of cavities on the teeth. The consistent use of prescription fluoride on teeth after radiation therapy for head and neck cancer may reduce the development of cavities and tooth loss. The purpose of this study is to find out if prescription fluoride varnish applied to the teeth every three months during the first year after radiation therapy changes the development of cavities or gum problems.
The overall objective of this clinical trial is to determine if oncology practices can reduce dental disease in head and neck cancer patients post radiation therapy. Participants will have fluoride varnish applied at planned oncology follow-up visits and medical oncology providers will be instructed on recognizing dental disease and referring head and neck cancer patients for dental care when needed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive Preventative Dental Program | Experimental | head and neck cancer patients receive fluoride varnish applied to teeth and follow-up dental screening during regularly scheduled oncology appointments. |
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| Regular Care | Active Comparator | control group consisting of head and neck cancer patients receiving regular care of no Intensive Preventative Dental Program. |
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| Medical Oncology Team Providers | Experimental | Medical Oncology care team members (MD, DO, PA, NP, RN) who participate in Intensive Preventative Dental Program. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoride varnish | Drug | fluoride varnish placed on teeth by a trained healthcare provider at four visits three months apart |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Decayed, Missing and Filled Surfaces Score | Decayed, Missing and Filled Surfaces Score (DMFS) is calculated by a calibrated oral examiner as the combined number of of decayed, missing, and/or filled tooth surfaces, from the baseline dental visit DMFS score before starting radiotherapy to the final dental visit DMFS score 12 months following completion of radiation therapy. | from baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Tooth Loss | Number of teeth lost per participant as determined by a calculated oral examiner from the baseline dental visit before the start of radiotherapy to the dental visit 12 months after completing radiation therapy. | from baseline to 12 months |
| Rate of Oral Hygiene Compliance |
| Measure | Description | Time Frame |
|---|---|---|
| Medical Oncology Care Team Post-study Feasibility Survey | The feasibility survey evaluates the logistics and success in implementing the Intensive Preventative Dental Program for Medical Oncology Team Providers treating head and neck cancer patients by gathering feedback from the Medical Oncology Care Team. Items are scored with 1-5 point Likert scale with a lower scale indicating higher satisfaction with the intervention. |
Inclusion Criteria:
OR
Diagnosed with a non-SCC, non-SGC malignancy of the head and neck region, and intends to receive RT, with or without concomitant chemotherapy. The participant must be expected to receive at least 4500 cGy to one of the following sites:
Willing to comply with all study procedures
Willing to participate for the duration of the study
RT follow-up planned for one of the selected AH Oncology Specialist Follow-up Sites.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael T Brennan, DDS, MHS | Atrium Health Wake Forest University Charlotte Medical Center | Principal Investigator |
| Matthew C. Ward, MD | Atrium Health Levine Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Levine Cancer Institute | Charlotte | North Carolina | 28203 | United States |
As this is a pilot study which forms the basis of a larger clinical trial, individual deidentified participant data will be shared upon reasonable request to the primary investigators, along with a data dictionary outlining variables collected and data collection forms when appropriate.
IPD will be available December 1, 2025 until at least December 1, 2030.
Individual deidentified participant data as outlined above will be shared upon reasonable request to the primary investigators until the conclusion of the follow-up study (approximately December 2030)
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 14, 2023 | Oct 30, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009057 | Stomatognathic Diseases |
| D003731 | Dental Caries |
| D006258 | Head and Neck Neoplasms |
| D010025 | Osteoradionecrosis |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Regular Care | Other | standard oncology assessment visit without Intensive Preventative Dental Program services |
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| Medical Oncology Care Team | Other | Medical Oncology care team members participating in the Intensive Preventative Dental Program will be guided on recognizing dental disease and when it is appropriate to refer head and neck cancer patients for dental care. |
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Number of participants who self-report daily toothbrushing and flossing from the baseline dental visit before the start of radiotherapy to the dental visit 12 months after completing radiation therapy. |
| from baseline to 12 months |
| Rate of Fluoride Compliance | Number of participants who self-reported use of prescription fluoride daily from the baseline dental visit before the start of radiotherapy to the dental visit 12 months after completing radiation therapy. | from baseline to 12 months |
| Rate of Routine/Preventative Dental Care | Number of participants who self-report visiting a dental office within the last six months from the baseline dental visit before the start of radiotherapy to the dental visit 12 months after completing radiation therapy. | from baseline to 12 months |
| 12 months |
| D011832 |
| Radiation Injuries |
| D014947 | Wounds and Injuries |