| Methods |
Trial design: single‐centre RCT (parallel group) Location: Italy, exact setting not specified Recruitment period: not stated Funding source: institutional funding Source of participants: patients attending clinic Study duration: 4 months Time points at which follow‐up are reported: from start of canine retraction for 4 months |
| Participants |
38: age range between 12 and 54 years, gender distribution not mentioned 19 in the mini‐screw implant group 19 in the conventional anchorage group
the need to distalize upper and/or lower canines into an extraction space, for a distance between 2 and 6 mm, in order to complete the correction of the overjet or the resolution of incisal crowding
|
| Interventions |
Placed between second premolar and molar, at an angle of 45º to 90º Chlorhexidine mouthwash 2% was prescribed 2 times/day 1 day before insertion and 15 days after insertion
This consisted of elastomeric chains or NiTi springs Attached to second premolar and first molars which were tied together by steel ligatures The force applied ranged from 75 to 150 g Replaced every 15 days to maintain force level Force was measured by using a 'dynamometer' 5‐mini‐implants were placed between molars Mini‐implants were placed between molars to act as markers for measurement of molar movement
|
| Outcomes |
Mesial movement (mm) of maxillary first molar measured clinically using the head of the implant as a reference, measure 4 months after commencement of space closure Success/failure of mini‐implant (loosening of mini‐implant) Duration of space closure phase |
| Notes |
Information for this study was obtained from a Google translation of the manuscript reporting the study
The method of measurement of molar movement used the head of the mini‐screw implants and the canines as a reference, it is unknown if the implant is a stable reference point |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Translated quote: "The items were assigned randomly to two groups of study: 19 were treated with distalisation…"
Comment: insufficient information about the sequence generation process to permit judgement |
| Allocation concealment (selection bias) |
Unclear risk |
The method of allocation concealment was not mentioned |
| 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: insufficient information to permit judgement Selective reporting of data: mesial movement of molars was incompletely reported as the means were reported without standard deviations |
| Other bias |
Low risk |
Study appears to be free of other sources of bias |
