Methods |
Trial design: single‐centre RCT (parallel group)
Location: Turkey
Recruitment period: not stated
Funding source: not stated
Source of participants: setting not stated
Study duration: not stated
Time points at which follow‐up are reported: before loading, after 1 month of loading the mini‐implants, and overall
|
Participants |
69 participants in total, 24 males and 32 females
22 in mini‐implant group (pilot hole diameter 1.1 mm): mean age of 15.2 years, 10 males and 12 females
20 in mini‐implant group (pilot hole diameter 0.9 mm): mean age 16.1 years, 7 males and 13 female
20 in mini‐implant group (self drilling): mean age 15.4 years, 7 males and 13 female
Angle Class II malocclusion
no history of trauma
no significant medical history
no congenital anomalies
no previous orthodontic treatment
|
Interventions |
Diameter 1.4 mm and body length of 7 mm
Had a pilot hole drilled with a drill of diameter 1.1 mm
Loaded after 2 weeks
Diameter 1.4 mm and body length of 7 mm
Had a pilot hole drilled with a drill of diameter 0.9 mm
Loaded after 2 weeks
Diameter 1.4 mm and body length of 7 mm
Self drilling (drill‐free) insertion was performed using a manual screwdriver
Loaded after 2 weeks
|
Outcomes |
‐ failure was recorded when there was significant mobility that could not sustain the orthodontic force ‐ this was assessed before loading, 1 month after loading and overall |
Notes |
Success and failure reported by implant and not by participant |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Quote: "Sixty‐two adolescent patients were randomly assigned to three groups" Comment: insufficient information about the sequence generation process to permit judgement |
Allocation concealment (selection bias) |
Unclear risk |
Not addressed |
Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Not addressed |
Incomplete outcome data (attrition bias)
mesial movement of upper first maxillary molar |
Low risk |
All randomised patients were analysed |
Selective reporting (reporting bias) |
High risk |
Selective reporting of outcomes: anchorage loss was not an objective of this study; however it would have been an expected outcome in this type of study
Selective reporting of data: no suggestion of selective reporting
|
Other bias |
Low risk |
Study appears to be free of other sources of bias |