Characteristics | n | % |
---|---|---|
Randomization ratio | ||
None | 369 | 90.9 |
1:1 | 30 | 7.4 |
1:1:1 | 2 | 0.5 |
1:1:1:1 | 1 | 0.2 |
2:1 | 1 | 0.2 |
2:2:1 | 1 | 0.2 |
3:1 | 1 | 0.2 |
5:1 | 1 | 0.2 |
Use of block randomization | ||
No | 369 | 90.9 |
Yes | ||
Single-block size | 16 | 3.9 |
Multi-block size | 4 | 0.9 |
Not disclosed block size | 17 | 4.3 |
Type of design | ||
Parallel | 357 | 87.7 |
Cross-over | 31 | 7.6 |
Cluster-based | 7 | 1.7 |
Single group assignment | 6 | 1.5 |
Split-mouth | 4 | 1.0 |
Split-face | 1 | 0.2 |
Intention-to-treat (ITT) and per protocol (PP) analyses | ||
ITT | 292 | 71.8 |
PP | 96 | 23.7 |
ITT and PP | 8 | 2.0 |
NA | 10 | 2.5 |
Reported overall rate of loss-to-follow up | ||
Yes | 69 | 17.0 |
No | 329 | 80.8 |
NA | 8 | 2.2 |
*Saudi Arabia, Bahrain, United Arab of Emirates, Kuwait, Oman, and Qatar, NA: not applicable, ITT: intention-to-treat analysis, PP: per protocol analysis