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

Abstract

BackgroundMost 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.MethodsThis 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.DiscussionThis 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 registrationClinicalTrials.gov Identifier NCT02057510, registered 5 February 2014.

Dental disease before radiotherapy in patients with head and neck cancer

“…10 The current study reports baseline dental findings and dental recommendations as of June 23, 2016. Also, data is reported for 5 of 6 enrollment sites because the sixth site, UNC, recently started enrollment and had only 1 participant enrolled at the time of this analysis.…”

“…10 The study received IRB approval at all enrollment sites. Consented participants are enrolled before they begin RT.…”

“…The following dental disease characteristics are collected for each participant at baseline: number of teeth; decayed, missing, and filled surfaces (DMFS); clinical attachment loss (CAL), probing depth (PD), and bleeding on probing (BOP) at six sites per tooth; plaque index at six sites on Ramfjord teeth; tooth mobility (grade 0 = no or physiologic mobility, grade 1 = up to 1 mm buccal-lingual (B-L) direction, grade 2 = 1-2 mm B-L direction, and grade 3 = >2 mm B-L direction or depressible); furcation involvement (grade 0 = none, grade 1 = early, grade 2 = probe penetrates between the roots, grade 3 = probe passes completely underneath crown, and grade 4 = supragingival grade 3 involvement); and radiographic findings of dental implants, impacted teeth, and periapical radiolucencies. 10 The dental treatment recommended was based on each site’s SOC radiographic and dental examination. The recommended treatment completed prior to the start of RT was documented.…”

Radiation-related caries assessment through the International Caries Detection and Assessment System and the Post-Radiation Dental Index

“…For this reason, it is of extreme importance that primary clinicians counsel patients after HNRT about oral and dental surveillance, including minimizing sugar intake, maintaining good oral hygiene and fluoride use, and keeping the dental care routine with a short interval between appointments (preferably every 3 months) so that any changes can be detected and treated in early stages. 23,24 Jackson et al, 25 in a recent attempt to develop an oral health evaluation tool for oral health outcomes in patients with HNC, also applied the ICDAS for dental assessment of patients after chemoradiation. They found that over 40% of the sample presented moderate-tosevere dental caries (ICDAS stages 5 and 6), corroborating our finding that the RRC lesions are predominately diagnosed in late stages.…”

Caries-associated oral microbiome in head and neck cancer radiation patients: a longitudinal study

“…Oral samples were not collected at 12 months post-RT, although the DMFS score data were available. A detailed description of methodology and an extensive overall description of the ORARAD study population regarding primary tumor site, oral hygiene and dental disease measures, and other oral complications have been previously reported [23][24][25].…”