title: Clinical registry of dental outcomes in head and neck cancer patients (OraRad): rationale, methods, and recruitment considerations.
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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier NCT02057510 , registered 5 February 2014.
authors.affiliation: Section of Oral Medicine, MC1605, University of Connecticut Health, 263, Farmington Avenue, Farmington, CT, 06030-1605, USA. Lalla@uchc.edu.
authors.forename: Rajesh V
authors.initials: RV
authors.lastname: Lalla
authors.affiliation: Division of Biostatistics, School of Public Health, University of Minnesota, 2221 University Ave SE Suite 200, Minneapolis, MN, 55414, USA.
authors.forename: Leslie
authors.initials: L
authors.lastname: Long-Simpson
authors.affiliation: Division of Biostatistics, School of Public Health, University of Minnesota, 2221 University Ave SE Suite 200, Minneapolis, MN, 55414, USA.
authors.forename: James S
authors.initials: JS
authors.lastname: Hodges
authors.affiliation: Division of Oral Medicine and Dentistry, Brigham and Women's Hospital, 1620 Tremont Street, 3rd Floor, Boston, MA, 02120, USA.|Department of Oral Medicine, Infection and Immunity, Harvard School of Dental Medicine, 188 Longwood Avenue, Boston, MA 02115, USA.
authors.forename: Nathaniel
authors.initials: N
authors.lastname: Treister
authors.affiliation: Department of Oral Medicine, University of Pennsylvania School of Dental Medicine, 240 South 40th Street, Philadelphia, PA, 19104, USA.
authors.forename: Thomas
authors.initials: T
authors.lastname: Sollecito
authors.affiliation: Department of Oral & Maxillofacial Surgery and Bluestone Center for Clinical Research, New York University College of Dentistry, 421 First Avenue, New York, NY, 10010, USA.
authors.forename: Brian
authors.initials: B
authors.lastname: Schmidt
authors.affiliation: Department of Dental Ecology, School of Dentistry, University of North Carolina, Chapel Hill, NC, CB 7450, USA.
authors.forename: Lauren L
authors.initials: LL
authors.lastname: Patton
authors.affiliation: Department of Oral Medicine, Carolinas Medical Center, 1000 Blythe Blvd, Charlotte, NC, 28203, USA.
authors.forename: Michael T
authors.initials: MT
authors.lastname: Brennan
mesh_terms: D015331:Cohort Studies; D004245:DMF Index; D006258:Head and Neck Neoplasms / Q000532:radiotherapy*; D006801:Humans; D009909:Oral Health / Q000706:statistics & numerical data; D010025:Osteoradionecrosis / Q000453:epidemiology / Q000209:etiology*; D018579:Patient Selection; D011829:Radiation Dosage; D011878:Radiotherapy / Q000009:adverse effects; D012042:Registries; D012107:Research Design; D012307:Risk Factors; D016388:Tooth Loss / Q000453:epidemiology / Q000209:etiology*; D016896:Treatment Outcome
keywords: Caries; Exposed bone; Head and neck cancer; Osteoradionecrosis; Periodontal disease; Protocol; Radiation therapy; Recruitment; Salivary flow; Tooth loss