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. 2014 Aug 19;2014(8):CD005098. doi: 10.1002/14651858.CD005098.pub3

Borsos 2008.

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

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

  • Inclusion criteria:

  1. dentoalveolar malocclusion requiring premolar extraction

  2. maximum anchorage

  3. ongoing skeletal growth

  4. adequate bone in the implant bed

  5. no relevant underlying disease

Interventions
  • Comparison 1: Immediately loaded mid‐palatal implant (Orthosystem, Straumann, Basle, Switzerland)

  1. Internal diameter of 3.8 mm, external diameter of 4.1 mm, length 4 mm

  2. Inserted by an oral and maxillofacial surgeon

  3. Loaded within 72 hours with a custom made, 1.2 x 1.2 mm transpalatal arch, attached to molar bands

  • Comparison 2: Conventional loaded mid‐palatal implant (Orthosystem, Straumann, Basle, Switzerland)

  1. Internal diameter of 3.8 mm, external diameter of 4.1 mm, length 4 mm

  2. Inserted by an oral and maxillofacial surgeon

  3. A non‐loaded spacer was applied after implantation

  4. Loaded after 12 weeks with a custom made, 1.2 x 1.2 mm transpalatal arch, attached to molar bands

Outcomes
  • Success of anchorage device (all implants remained stable throughout treatment)

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

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