Design of the Prevention of Adult Caries Study (PACS): A randomized clinical trial assessing the effect of a chlorhexidine dental coating for the prevention of adult caries

Table 3 Schedule of Study Visits

	SV (t_s)	V1 (t₀)	V2 (t₁)	V3 (t₂)	V4 (t₃)	V5 (t₄)	V5a (t₅) Tufts only	V6 (t₆)	V6a (t₇) Tufts only
Target date		t_{s +} 4 mos	t₀+7d	t₁+7 d	t₂+7 d	t₀+7 mos	t₀+10 mos	t₀+13 mos	t₀+19 mos
Allowable window			5-14 d	5-14 d	5-14 d	± 1 mo	± 1 mo	± 1 mo	± 1 mo
Eligibility questions	X	X¹
Exam for eligibility	X
Demographic questions	X
Informed consent	X	X²
Dental restorations	X³					X³		X³
Pregnancy test	X	X				X
Acidic drink consumption questions	X				X	X		X
Medical HX questions		X				X		X
Oral Health HX questions		X						X
Randomization		X
Tooth Surface Exam		X				X		X
Coating Application		X	X	X	X	X
Adverse Events questions		X	X	X	X	X	X	X	X
Medication questions	X	X	X	X	X	X	X	X	X
Soft Tissue Exam		X				X		X
Travel time/costs		X				X		X
Care Utilization								X
Candidiasis Lab Tracking	X	X	X	X	X	X	X	X	X
Medication Price Survey		X
Microbiology Tufts only		X⁴				X⁴	X⁴	X⁵	X⁵

1 some eligibility information will be reassessed at V1
2 although not required, some study centers will use separate screening and randomization consent forms
3 following the screening visit (SV), any needed dental restorations are made prior to randomization (V1); additional restorative work, if needed, is performed following the dental examinations at the V5 and V6 visits
4 testing for presence and level of S. mutans and C. albicans in a subset of patients at the Tufts clinical center
5 additional testing for S. mutans and C. albicans may occur at V6 and V6a depending on results of earlier tests

ISSN: 1472-6831