Observational Study of Dental Outcomes in Head and Neck Cancer Patients

NCT ID: NCT02057510

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 575 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2026-06-30

Brief Summary

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.

Detailed Description

This is a prospective cohort study to document dental and other oral outcomes in patients who receive external beam radiation therapy with curative intent, as part of clinical care for a head and neck cancer. Five hundred and seventy-five participants will be enrolled. All study participants will receive a baseline oral examination prior to the start of radiation therapy. Follow-up examinations and data collection will be conducted at six-month intervals up to 2 years after the start of radiation therapy. The primary outcome will be the two-year rate of tooth loss. Secondary outcomes will include measures of dental caries, periodontal health, salivary flow, and exposed bone/osteoradionecrosis.

The proposed research will provide more information to inform the community about the sequelae of Radiation Therapy (RT) in head and neck cancer patients, to refine current guidelines and to design future studies on the dental management of these patients.

Conditions

Head and Neck Cancer; Dental Disease; Xerostomia; Osteoradionecrosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients receiving head and neck RT

No intervention

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: collaborator

UConn Health

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: collaborator

University of North Carolina

OTHER

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael T Brennan, DDS, MHS

Role: STUDY_CHAIR

Wake Forest University Health Sciences

Rajesh Lalla, DDS, PhD

Role: STUDY_CHAIR

University of Connecticut Health Center - School of Dental Medicine

Locations

University of Connecticut Health Center - School of Dental Medicine

Farmington, Connecticut, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

New York University - College of Dentistry

New York, New York, United States

University of North Carolina - School of Dentistry

Chapel Hill, North Carolina, United States

Carolinas Medical Center - Dental Clinic

Charlotte, North Carolina, United States

University of Pennsylvania - School of Dental Medicine

Philadelphia, Pennsylvania, United States

Countries

United States

References

Brennan 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.

Reference Type: RESULT

PMID: 29173331 (View on PubMed)

Lalla 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.

Reference Type: RESULT

PMID: 28675770 (View on PubMed)

Lalla 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.

Reference Type: RESULT

PMID: 28241807 (View on PubMed)

Brennan 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.

Reference Type: RESULT

PMID: 32991009 (View on PubMed)

Talevi 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.

Reference Type: RESULT

PMID: 32451231 (View on PubMed)

Mougeot 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.

Reference Type: RESULT

PMID: 30891159 (View on PubMed)

Brennan MT, Treister NS, Sollecito TP, Schmidt BL, Patton LL, Lin A, Elting LS, Hodges JS, Lalla RV. Tooth Failure Post-Radiotherapy in Head and Neck Cancer: Primary Report of the Clinical Registry of Dental Outcomes in Head and Neck Cancer Patients (OraRad) Study. Int J Radiat Oncol Biol Phys. 2022 Jun 1;113(2):320-330. doi: 10.1016/j.ijrobp.2021.11.021. Epub 2021 Dec 5.

Reference Type: RESULT

PMID: 34879248 (View on PubMed)

Lalla RV, Treister NS, Sollecito TP, Schmidt BL, Patton LL, Helgeson ES, Lin A, Rybczyk C, Dowsett R, Hegde U, Boyd TS, Duplinsky TG, Brennan MT. Radiation therapy for head and neck cancer leads to gingival recession associated with dental caries. Oral Surg Oral Med Oral Pathol Oral Radiol. 2022 May;133(5):539-546. doi: 10.1016/j.oooo.2022.01.016. Epub 2022 Jan 31.

Reference Type: RESULT

PMID: 35304084 (View on PubMed)

Brennan MT, Treister NS, Sollecito TP, Schmidt BL, Patton LL, Lin A, Elting LS, Helgeson ES, Lalla RV. Dental Caries Postradiotherapy in Head and Neck Cancer. JDR Clin Trans Res. 2023 Jul;8(3):234-243. doi: 10.1177/23800844221086563. Epub 2022 Apr 11.

Reference Type: RESULT

PMID: 35403479 (View on PubMed)

Lin A, Helgeson ES, Treister NS, Schmidt BL, Patton LL, Elting LS, Lalla RV, Brennan MT, Sollecito TP. The impact of head and neck radiotherapy on salivary flow and quality of life: Results of the ORARAD study. Oral Oncol. 2022 Apr;127:105783. doi: 10.1016/j.oraloncology.2022.105783. Epub 2022 Feb 26.

Reference Type: RESULT

PMID: 35231809 (View on PubMed)

Treister NS, Brennan MT, Sollecito TP, Schmidt BL, Patton LL, Mitchell R, Haddad RI, Tishler RB, Lin A, Shadick R, Hodges JS, Lalla RV. Exposed bone in patients with head and neck cancer treated with radiation therapy: An analysis of the Observational Study of Dental Outcomes in Head and Neck Cancer Patients (OraRad). Cancer. 2022 Feb 1;128(3):487-496. doi: 10.1002/cncr.33948. Epub 2021 Oct 19.

Reference Type: RESULT

PMID: 34665873 (View on PubMed)

Ward MC, Carpenter MD, Noll J, Carrizosa D, Moeller BJ, Helgeson ES, Lalla RV, Brennan MT. Oncologists' Perspective on Dental Care Around the Treatment of Head and Neck Cancer: A Pattern of Practice Survey. JCO Oncol Pract. 2022 Jan;18(1):e28-e35. doi: 10.1200/OP.20.00913. Epub 2021 Jul 9.

Reference Type: RESULT

PMID: 34242067 (View on PubMed)

Threet EJ, Napenas JJ, Petersen C, Mitchell R, Long-Simpson L, Shadick R, Valentino KC, Rybczyk CA, Blake JA, Brown MC, Aidoo R, Helgeson ES, Lalla RV, Brennan MT. Survey of experiences and barriers to dental care post-head and neck cancer in OraRad study participants. Oral Surg Oral Med Oral Pathol Oral Radiol. 2023 Apr;135(4):501-509. doi: 10.1016/j.oooo.2022.11.011. Epub 2022 Dec 13.

Reference Type: RESULT

PMID: 36717342 (View on PubMed)

Lalla RV, Hodges JS, Treister NS, Sollecito TP, Schmidt BL, Patton LL, Lin A, Brennan MT. Tooth-level predictors of tooth loss and exposed bone after radiation therapy for head and neck cancer. J Am Dent Assoc. 2023 Jun;154(6):519-528.e4. doi: 10.1016/j.adaj.2023.03.009.

Reference Type: RESULT

PMID: 37236706 (View on PubMed)

Patton LL, Helgeson ES, Brennan MT, Treister NS, Sollecito TP, Schmidt BL, Lin A, Chera BS, Lalla RV. Oral health-related quality of life after radiation therapy for head and neck cancer: the OraRad study. Support Care Cancer. 2023 Apr 20;31(5):286. doi: 10.1007/s00520-023-07750-2.

Reference Type: RESULT

PMID: 37079106 (View on PubMed)

Other Identifiers

1U01DE022939-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

12-040-E

Identifier Type: -

Identifier Source: org_study_id