Table 4 Time schedule of enrolment, interventions and assessments according to the SPIRIT statement

TIMEPOINT

-T₀

0

T₀

1w

4w

12w

24w

24 weeks

ENROLMENT:

Eligibility screen

X

X

Informed consent

X

Data protection, Information material

X

Allocation

X

INTERVENTIONS:

L. reuteri Prodentis®-lozenges (DSM 17938, ATCC PTA 5289)

Control lozenges

ASSESSMENTS (NCT04598633* and NCT04606186*):

Gingival Index

X

X

X

X

X

X

Probing Pocket Depth

X

X

X

X

X

X

Modified Plaque Index

X

X

X

X

X

X

Local cytokine concentration¹

X

X

X

X

X

X

Oral microbiota¹

X

X

X

X

X

X

ASSESSMENTS (NCT04606186*):

Serum cytokine levels ²

X

X

X

Frequencies of innate and adaptive immune cells²

X

X

X