Table 5.
Validity | Quality criteria | Study |
||||||
---|---|---|---|---|---|---|---|---|
Alissa et al., 2010 [15] | Farina et al., 2013 [21] | Suttapreyasri and Leepong 2013 [17] | Hauser et al. 2013 [18] | Anitua et al. 2015 [16] | Marenzi et al. 2015 [19] | Temmerman et al. 2016 [20] | ||
External | declared use specific protocol guidelines | yes | NR | NR | NR | yes | NR | NR |
representative population group | yes | yes | yes | yes | yes | yes | yes | |
eligibility criteria defined | yes | yes | yes | yes | yes | NR | yes | |
Internal | consecutive enrollment | NR | NR | NR | NR | NR | NR | NR |
random allocation | yes | NA | yes | yes | yes | yes | yes | |
allocation concealment | yes | NA | NR | NR | yes | NR | yes | |
blinding of the patient | NR | no | NR | NR | NR | NR | NR | |
blinding of the examiner | yes | yes | NR | yes | yes | NR | NR | |
blinding of the statistician | NR | NR | NR | NR | NR | NR | NR | |
reported loss to follow-up | yes | yes | NR | yes | yes | yes | yes | |
no. (%) of dropouts | 7 (30.4%) | 0 | 0 | 1 (4.34%) | 8 (13%) | 0 | 0 | |
treatment identical, except for intervention | yes | yes | yes | yes | yes | yes | yes | |
Statistical | sample size calculation and power | yes§ | NR | NR | NR | yes | NR | yes |
point estimates presented for primary outcome | yes | yes | yes | yes | yes | yes | yes | |
measures of variability for the primary outcome | yes | yes | yes | yes | yes | yes | yes | |
intention to treat analysis | yes | NR | NR | NR | NR | NR | NR | |
coherent data presentation | yes | yes | no | no | yes | no | yes | |
Clinical aspects | study design# | RCT parallel | CCT parallel | RCT split-mouth | RCT parallel | RCT parallel | RCT split-mouth | RCT split-mouth |
validated measurement | NR | NR | NR | NR | NR | NR | NR | |
calibration of examiner | yes | yes | NR | NR | NR | NR | NR | |
estimated potential risk of bias | low | moderate | high | high | low | high | moderate |
NR = Not reported; NA = not applicable; RCT = randomized clinical trial; CCT = controlled clinical trial-°Relevant if >20%.
Calculated sample size not reached.
Higher risk of bias for RCT versus CCT.