Clinical trial · Interventional
Intensive Preventative Dental Program Pilot Study
NCT07218068CI-TRIAL-00096946IPDPcompletedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dental Diseases | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluoride varnish | Drug | — | UNRESOLVED |
| Medical Oncology Care Team | Other | — | UNRESOLVED |
| Regular Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Intensive Preventative Dental Program
- description
- head and neck cancer patients receive fluoride varnish applied to teeth and follow-up dental screening during regularly scheduled oncology appointments.
- interventionNames
- Drug: Fluoride varnish
- type
- ACTIVE_COMPARATOR
- label
- Regular Care
- description
- control group consisting of head and neck cancer patients receiving regular care of no Intensive Preventative Dental Program.
- interventionNames
- Other: Regular Care
- type
- EXPERIMENTAL
- label
- Medical Oncology Team Providers
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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: 1. base of tongue 2. buccal/labial mucosa 3. epiglottis 4. floor of mouth 5. gingiva/alveolar ridge 6. hard palate 7. hypopharynx 8. larynx 9. lip 10. mandible 11. maxilla 12. maxillary sinus 13. nasal cavity 14. nasopharynx 15. neck 16. oral cavity 17. oral tongue 18. oropharynx 19. paranasal sinus/orbit 20. parotid gland 21. pharynx 22. retromolar trigone 23. soft palate 24. sublingual gland 25. submandibular gland 26. 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 Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.