Skip to main content
. 2018 May 3;45(3):195–203. doi: 10.1159/000488061

Table 5.

Quality assessment of included studies

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.