Clinical registry of dental outcomes in head and neck cancer patients (OraRad): Rationale, methods, and recruitment considerations

Rajesh V. Lalla, Leslie Long-Simpson, James S. Hodges, Nathaniel Treister, Thomas Sollecito, Brian Schmidt, Lauren L. Patton, Michael T. Brennan, OraRad Study Group

Research output: Research - peer-reviewArticle

Abstract

Background: Most head and neck (H&N) cancer patients receive high-dose external beam radiation therapy (RT), often in combination with surgery and/or chemotherapy. Unfortunately, high-dose RT has significant adverse effects on the oral and maxillofacial tissues, some of which persist for the life of the patient. However, dental management of these patients is based largely on individual and expert opinion, as few studies have followed patients prospectively to determine factors that predict adverse oral sequelae. In addition, many previous studies were conducted before wide-spread adoption of intensity-modulated radiation therapy (IMRT) and concurrent chemotherapy. The objective of this multi-center study is to systematically evaluate the oral health of subjects for 2 years after commencement of RT, with the goal of identifying risk factors that predict adverse oral outcomes post-RT. Methods: This is a prospective multi-center longitudinal cohort study of H&N cancer patients who receive high-dose RT with curative intent. Planned enrollment is 756 subjects at 6 primary clinical sites (and their affiliated sites) in the USA. A baseline visit is conducted prior to the beginning of RT. Follow-up visits are conducted at 6, 12, 18 and 24 months from the start of RT. The primary outcome measure is the 2-year rate of tooth loss in patients who have received at least one session of external beam RT for H&N cancer. Secondary outcome measures include the incidence of exposed intraoral bone; incidence of post-extraction complications; change in Decayed Missing and Filled Surfaces (DMFS); change in periodontal measures; change in stimulated whole salivary flow rates; change in mouth opening; topical fluoride utilization; chronic oral mucositis incidence; changes in RT-specific quality of life measures; and change in oral pain scores. Discussion: This study will contribute to a better understanding of the dental complications experienced by these patients. It will also enable identification of risk factors associated with adverse outcomes such as tooth loss and osteoradionecrosis. These findings will support the development of evidence-based guidelines and inform the planning of future interventional studies, with the goal of advancing improvements in patient care and outcomes. Trial registration: ClinicalTrials.gov Identifier NCT02057510 , registered 5 February 2014.

LanguageEnglish (US)
Article number59
JournalBMC Oral Health
Volume17
Issue number1
DOIs
StatePublished - Feb 27 2017

Fingerprint

Head and Neck Neoplasms
Registries
Tooth
Radiotherapy
Incidence
Neoplasms
Tooth Loss
Outcome Assessment (Health Care)
Drug Therapy
Osteoradionecrosis
Topical Fluorides
Stomatitis
Oral Health
Expert Testimony
Longitudinal Studies
Mouth
Patient Care
Cohort Studies
Neck
Head

Keywords

  • Caries
  • Exposed bone
  • Head and neck cancer
  • Osteoradionecrosis
  • Periodontal disease
  • Protocol
  • Radiation therapy
  • Recruitment
  • Salivary flow
  • Tooth loss

ASJC Scopus subject areas

  • Dentistry(all)

Cite this

Lalla, R. V., Long-Simpson, L., Hodges, J. S., Treister, N., Sollecito, T., Schmidt, B., ... OraRad Study Group (2017). Clinical registry of dental outcomes in head and neck cancer patients (OraRad): Rationale, methods, and recruitment considerations. BMC Oral Health, 17(1), [59]. DOI: 10.1186/s12903-017-0344-y

Clinical registry of dental outcomes in head and neck cancer patients (OraRad) : Rationale, methods, and recruitment considerations. / Lalla, Rajesh V.; Long-Simpson, Leslie; Hodges, James S.; Treister, Nathaniel; Sollecito, Thomas; Schmidt, Brian; Patton, Lauren L.; Brennan, Michael T.; OraRad Study Group.

In: BMC Oral Health, Vol. 17, No. 1, 59, 27.02.2017.

Research output: Research - peer-reviewArticle

Lalla, RV, Long-Simpson, L, Hodges, JS, Treister, N, Sollecito, T, Schmidt, B, Patton, LL, Brennan, MT & OraRad Study Group 2017, 'Clinical registry of dental outcomes in head and neck cancer patients (OraRad): Rationale, methods, and recruitment considerations' BMC Oral Health, vol 17, no. 1, 59. DOI: 10.1186/s12903-017-0344-y
Lalla, Rajesh V. ; Long-Simpson, Leslie ; Hodges, James S. ; Treister, Nathaniel ; Sollecito, Thomas ; Schmidt, Brian ; Patton, Lauren L. ; Brennan, Michael T. ; OraRad Study Group. / Clinical registry of dental outcomes in head and neck cancer patients (OraRad) : Rationale, methods, and recruitment considerations. In: BMC Oral Health. 2017 ; Vol. 17, No. 1.
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