Status:
COMPLETED
Intensive Preventative Dental Program Pilot Study
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Dental Diseases
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
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 ...
Detailed Description
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 va...
Eligibility Criteria
Inclusion
- Aged 18 years and older
- Willing and able to provide signed and dated consent form
- Presence of at least 4 natural erupted teeth remaining in the mouth after completion of pre-RT dental management
- Diagnosed with head and neck squamous cell carcinoma (SCC) or a salivary gland cancer (SGC), and intends to receive external beam radiation therapy (RT) with curative intent (tumor eradication), with or without concomitant chemotherapy;
- 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:
- base of tongue
- buccal/labial mucosa
- epiglottis
- floor of mouth
- gingiva/alveolar ridge
- hard palate
- hypopharynx
- larynx
- lip
- mandible
- maxilla
- maxillary sinus
- nasal cavity
- nasopharynx
- neck
- oral cavity
- oral tongue
- oropharynx
- paranasal sinus/orbit
- parotid gland
- pharynx
- retromolar trigone
- soft palate
- sublingual gland
- submandibular gland
- tonsil;
- 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
- Receiving palliative RT
- History of prior curative RT to the head and neck region to eradicate a malignancy.
- Incarcerated at the time of screening
- Anything that would place the participant at increased risk or preclude the participant's full compliance with or completion of the study.
Key Trial Info
Start Date :
October 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2024
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT07218068
Start Date
October 19 2021
End Date
July 10 2024
Last Update
November 3 2025
Active Locations (1)
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1
Levine Cancer Institute
Charlotte, North Carolina, United States, 28203