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

Table 1 Study Procedures at each time-point (per SPIRIT guidelines)

Procedures		Screening	Baseline Visit (0 – 42 days before RT begins)	Baseline records review after RT	Follow-up Visit 1 (182 ± 30 days after RT begins)	Follow-up Visit 2 (364 ± 30 days after RT begins)	Follow-up Visit 3 (546 ± 30 days after RT begins)	Follow-up Visit 4 (728 ± 30 days after RT begins)	Early Withdrawal Visit	Unscheduled Visit
Consent for screening, assess eligibility, record basic demographic data		X
Obtain signed study consent form, confirm eligibility			X
Review medical and dental records	Diagnosis and treatment plan	X	X
	Medication use		X		X	X	X	X	X
	Pre-RT dental care delivered			X
	Data on extractions and complications		X		X	X	X	X	X
	Total amount of radiation received			X
Oral/Dental Assessment	DMFS		X		X	X	X	X	X
	Number of teeth, removable prostheses		X		X	X	X	X	X
	Presence of intrabony devices		X
	Periodontal measures^a		X			X		X	X^c
	WHO oral mucositis scale		X		X	X	X	X	X
	Mouth opening measurement		X		X	X	X	X	X
	Panoramic radiograph^b		X
	Tooth loss, ORN, dental infection/complication		X		X	X	X	X	X
Measure salivary flow rate			X		X		X		X^c
Obtain participant-reported data	Demographics, tobacco and alcohol use		X
	Fluoride use and oral hygiene practices		X		X	X	X	X	X
	Oral cancer pain assessment		X		X	X	X	X	X
	Oral health-related quality of life (RT-specific)		X		X	X	X	X	X
Post-extraction/exfoliation/exposed bone assessment (if applicable)			X		X	X	X	X	X	X

^aPeriodontal measures at baseline include clinical attachment loss, bleeding on probing, pocket depth, gingival recession, plaque index, tooth mobility and furcation involvement; at follow-up visits, plaque index, tooth mobility and furcation involvement are not recorded
^bFindings from clinical radiograph are recorded; radiograph is taken for study only if a current (<180 days) radiograph from routine clinical care is not available
^cMeasured at early withdrawal visit only if it would have been done at next scheduled visit

ISSN: 1472-6831