Clinical trial · Observational
Observational Study of Dental Outcomes in Head and Neck Cancer Patients
Clinical Registry of Dental Outcomes in Head and Neck Cancer Patients
NCT02057510CI-TRIAL-00116293ORARADcompletedClinicalTrials.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)
The purpose of this study is to measure the two-year rate of tooth loss in patients who have received external beam radiation therapy with curative intent for head and neck cancer. The study will also evaluate the sequelae of radiation therapy and oral complications that may occur as a result to receiving radiation therapy.
Conditions
Conditions (4)
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 Disease | — | UNRESOLVED | — |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Osteoradionecrosis | — | UNRESOLVED | — |
| Xerostomia | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Patients receiving head and neck RT
- description
- No intervention
Primary outcomes (1)
- measure
- Tooth loss
- timeFrame
- Two Years
- description
- The primary outcome measure is the two-year rate of tooth loss in patients who have received at least one session of external beam radiation therapy with curative intent for head and neck cancer. "Tooth loss" will be defined as a dental extraction that has been performed or recommended. Since dental extractions are often avoided in this population because of the increased risk of osteoradionecrosis (ORN), tooth loss will also include teeth having a dental procedure to avoid extraction of a tooth that would otherwise have been extracted if the individual had not received RT and teeth recommended for extraction that have not been treated. The following categories will constitute teeth that would otherwise be recommended for extraction: * non-restorable because of fracture or extent of caries; * amputated crown with root remaining; * uncontrolled or persistent periodontal or odontogenic infection.
Secondary outcomes (10)
- measure
- Incidence of exposed intraoral bone
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; * 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 subject 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; * At least 1 natural tooth remaining or expected to remain in the mouth after completion of the pre-RT dental extractions, if any; * Willing to comply with all study procedures; * Willing to participate for the duration of the study. Exclusion Criteria: * Receiving palliative RT; * History of prior curative RT to the head and neck region to eradicate a malignancy; * Incarcerated at time of screening; * Anything that would place the subject at increased risk or preclude the subject's full compliance with or completion of the study.
References
Publications (20)
- RESULTBrennan MT, Treister NS, Sollecito TP, Schmidt BL, Patton LL, Mohammadi K, Long Simpson L, Voelker H, Hodges JS, Lalla RV. Dental disease before radiotherapy in patients with head and neck cancer: Clinical Registry of Dental Outcomes in Head and Neck Cancer Patients. J Am Dent Assoc. 2017 Dec;148(12):868-877. doi: 10.1016/j.adaj.2017.09.011. PMID 29173331
- RESULTLalla RV, Treister N, Sollecito T, Schmidt B, Patton LL, Mohammadi K, Hodges JS, Brennan MT; OraRad Study Group. Oral complications at 6 months after radiation therapy for head and neck cancer. Oral Dis. 2017 Nov;23(8):1134-1143. doi: 10.1111/odi.12710. Epub 2017 Aug 3. PMID 28675770
- RESULTLalla RV, Long-Simpson L, Hodges JS, Treister N, Sollecito T, Schmidt B, Patton LL, Brennan MT; OraRad Study Group. Clinical registry of dental outcomes in head and neck cancer patients (OraRad): rationale, methods, and recruitment considerations. BMC Oral Health. 2017 Feb 27;17(1):59. doi: 10.1186/s12903-017-0344-y. PMID 28241807
- RESULTBrennan MT, Treister NS, Sollecito TP, Schmidt BL, Patton LL, Yang Y, Lin A, Elting LS, Hodges JS, Lalla RV. Epidemiologic factors in patients with advanced head and neck cancer treated with radiation therapy. Head Neck. 2021 Jan;43(1):164-172. doi: 10.1002/hed.26468. Epub 2020 Sep 29. PMID 32991009
- RESULTTalevi V, Wen J, Lalla RV, Brennan MT, Mougeot FB, Mougeot JC. Identification of single nucleotide pleomorphisms associated with periodontal disease in head and neck cancer irradiation patients by exome sequencing. Oral Surg Oral Med Oral Pathol Oral Radiol. 2020 Jul;130(1):32-42.e4. doi: 10.1016/j.oooo.2020.02.013. Epub 2020 May 22. PMID 32451231
- RESULTMougeot JC, Stevens CB, Almon KG, Paster BJ, Lalla RV, Brennan MT, Mougeot FB. Caries-associated oral microbiome in head and neck cancer radiation patients: a longitudinal study. J Oral Microbiol. 2019 Mar 8;11(1):1586421. doi: 10.1080/20002297.2019.1586421. eCollection 2019.