Methods |
Trial design: single‐centre RCT (parallel group)
Location: Department of Orthodontics, Second Hospital of Hebei Medical University, China
Recruitment period: not stated
Funding source: not stated
Source of participants: patients attending clinic
Study duration: not stated
Time points at which follow‐up are reported: before and after treatment
|
Participants |
Patients with severe maxillary or bimaxillary protrusion
20 participants in total (14 females, 6 males), 15‐27 years old, mean age 20.7 years
10 in mini‐implant group
10 in the conventional anchorage group
maxillary or bimaxillary protrusion
extraction of the upper and lower first premolars, or the upper first premolars and lower second premolars
|
Interventions |
1.5 mm diameter, 8 mm length
Positioned in the buccal alveolar crest between upper first molar and second premolar
Loaded by a force of 150 g on each side, every 4 weeks
Consisting of headgear and transpalatal arches
|
Outcomes |
Molar mesiodistal movement on lateral cephalometric radiographs; U6‐PTV (distance from mesiobuccal apex of the upper first molar to PTV) |
Notes |
The full text article is in Chinese; this information was obtained from a translation of the article |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
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 |
There were 2 drop‐outs in the mini‐screw implant group; due to loss of implants |
Selective reporting (reporting bias) |
Unclear 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 |