Methods |
Trial design: single‐centre RCT (parallel group)
Location: Semmelweis University, Budapest, Hungary
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: at the end of orthodontic treatment
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Participants |
16 participants in total, mean age 14.22 +/‐ 1.37 years
8 in the immediate loading group: mean age 14.15 +/‐ 1.2 years, 5 males and 3 females
8 in the conventional loading group: mean age 14.3 +/‐ 1.6 years, 3 males and 5 females
dentoalveolar malocclusion requiring premolar extraction
maximum anchorage
ongoing skeletal growth
adequate bone in the implant bed
no relevant underlying disease
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Interventions |
Internal diameter of 3.8 mm, external diameter of 4.1 mm, length 4 mm
Inserted by an oral and maxillofacial surgeon
Loaded within 72 hours with a custom made, 1.2 x 1.2 mm transpalatal arch, attached to molar bands
Internal diameter of 3.8 mm, external diameter of 4.1 mm, length 4 mm
Inserted by an oral and maxillofacial surgeon
A non‐loaded spacer was applied after implantation
Loaded after 12 weeks with a custom made, 1.2 x 1.2 mm transpalatal arch, attached to molar bands
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Outcomes |
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Notes |
The main outcome of this study was the histological evaluation of the bone‐implant contact after treatment |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Quote: "The patients were randomly assigned to treatment groups in groups of four at a 1:1 ratio" 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 accounted for |
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 data on the pain and discomfort, the results were reported narratively and for the sample as a whole
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Other bias |
High risk |
Fixed size blocks were used in a small single‐centre unblinded trial. This may make it possible to predict future assignments |