1
|
Were the harms PRE-DEFINED using standardized or precise definitions?
|
1
|
0
|
|
(In present study, we defined “harms” as the totality of adverse consequences of an implant surgery) |
|
|
2
|
Were SERIOUS events precisely defined?
|
1
|
0
|
|
(In present study, we defined complications that didn't lead to IMPLANT LOSS or IMPLANT REMOVAL as SERIOUS events, e.g. sensitivity on function, radiographic bone loss ≤4 mm or 1/2 of the implant body, probing depth ≤7 mm, etc. [14]) |
|
|
3
|
Were SEVER events precisely defined?
|
1
|
0
|
|
(In present study, we defined IIMPLANT LOSS as SERIOUS events)
|
|
|
4
|
Did the study specify the TRAINING or BACKGROUND of who ascertained the harms?
|
1
|
0
|
5
|
Did the study specify the TIMING and FREQUENCY of collection of the harms?
|
1
|
0
|
6
|
Did the author(s) use STANDARD scale(s) or checklist(s) for harms collection?
|
1
|
0
|
7
|
Was the NUMBER of participants that withdrew or were lost to follow-up specified for each study group?
|
1
|
0
|
8
|
Was the TOTAL NUMBER of participants affected by harms specified for each study arm?
|
1
|
0
|
9
|
Did the author(s) specify the NUMBER for each TYPE of harmful event for each study group?
|
1
|
0
|
10
|
Did the author(s) specify the type of analyses undertaken for harms data?
|
1
|
0
|
A Total of 10 Points
|