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

Jackson 2008.

Methods
  • Trial design: single‐centre RCT (parallel groups)

  • Location: University Clinic, San Antonio Texas

  • Recruitment period: not stated

  • Funding source: a source of support was provided by both the American Academy of Esthetic Dentistry, in the form of a grant, and Straumann, in the form of equipment

  • Source of participants: patients attending clinic

  • Study duration: 8 weeks

  • Time points at which follow‐up are reported: from the time of implant placement until 8 weeks post‐placement

Participants
  • 20 patients, 13‐48 years old, 12 females, 8 males (1 drop‐out not accounted for)

  • 10 in the immediately loading group

  • 10 in the delayed loading group

  • Inclusion criteria:

  1. dental patients seeking orthodontic treatment

  2. orthodontic implants were deemed necessary for treatment by their orthodontist

  3. both maxillary first molars erupted and present

  4. sufficient bone quantity to completely encase a palatal implant

Interventions
  • Comparison 1: Strauman palatal implants, immediately loaded

  1. 3.3 mm diameter, 4 or 6 mm length

  2. Placed by a surgeon

  3. Implants were immediately loaded on the day of surgery by an activated 5 mm coil spring attached to a palatal arch

  • Comparison 2: Strauman palatal implants, delayed loading

  1. 3.3 mm diameter, 4 or 6 mm length

  2. Placed by a surgeon

  3. Implants were not loaded on the day of surgery as they were attached to the palatal arch with an annealed coil spring, thus not producing any forces

Outcomes Clinical success of the palatal implant defined as the ability to use the implant in the course of orthodontic treatment
Notes The main study outcome was implant stability, not success of anchorage device. The duration of this study was 8 weeks, and the definition for clinical success of the mini‐screw implants was the ability to use the implant in the course of orthodontic treatment. An endpoint of 8 weeks after mini‐screw implant placement does not represent a course of orthodontic treatment
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "All patients in the study were randomised to either immediately loaded or non loaded treatments using the method of randomly permuted blocks"
Quote: "The randomization scheme was generated by using the web site Randomization.com"
Allocation concealment (selection bias) Low risk Quote: "Third party volunteer sealed the treatment assignment for each participant in a brown envelope, which was open immediately prior to placement of the midpalatal implant"
Quote: "Group designation obtained by randomization was revealed to the primary investigator on the day of the surgery"
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 1 patient dropped out from the immediate loading group due to failure of the implant
Selective reporting (reporting bias) High risk
  • Selective reporting of outcomes: does not report anchorage loss

  • Selective reporting of data: no suggestion of selective reporting

Other bias Low risk Study appears to be free of other sources of bias