Gallucci 2011.
Methods | 2‐year follow‐up, randomised, parallel‐group study | |
Participants | 20 patients with 1 missing tooth in the anterior maxilla (first bicuspid to first bicuspid) and presence of 2 intact adjacent teeth Inclusion criteria:
Exclusion criteria:
|
|
Interventions | 2 different types of screw‐retained single implant crowns Group 1: 10 all ceramic single crowns Group 2: 10 PFM single crowns Implant insertion:
Provisionalization:
Impressions and lab work:
|
|
Outcomes |
|
|
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "All participants were randomly assigned to one the two treatment options. A random permuted block system was generated by a collaborator not involved in the study. Six permuted blocks containing three test and three control subjects were generated and included in 24 sealed envelopes. A copy of the randomization sequence was preserved for accuracy assessment at the end of the study. The permuted block randomization system ensured the uniformity of the patient allocation during the clinical trial by randomly distributing three participants to the test and three participants to the control group every six treated patients" |
Allocation concealment (selection bias) | Low risk | Quote: "Upon patient's enrolment, a sealed envelope was assigned by order of inclusion in the study. In order to avoid bias during the prosthodontic treatment, the individually assigned sealed envelopes were only opened after final impression taking and were subsequently sent to the dental laboratory for fabrication of the implant crowns" |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "For the objective assessment at baseline, the study design was double blinded because neither the investigators nor the patients were aware of the assigned group" |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "For the objective assessment at baseline, the study design was double blinded because neither the investigators nor the patients were aware of the assigned group. For the objective measurements at CI, 1Y, and 2Y, the study design was single‐blinded being only the participants unaware of the group they were allocated. For the subjective evaluation, the trial design was double blinded. Neither the patients nor external expert clinicians were informed about the results of the randomization" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "Three dropouts were recorded. Two patients moved abroad before receiving the final crowns and one patient was unreachable after completing the 1Y" |
Selective reporting (reporting bias) | Low risk | None identified |
Other bias | Low risk | None identified |