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

Ma 2008.

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

  • Location: Orthodontic Department at the School of Stomatology, Nanjing Medical University, China

  • Recruitment period: not stated

  • Funding source: The Science and Technology Department, Education Department of Jiangsu Province; and the National Natural Science Foundation of China

  • Source of participants: patients attending clinic

  • Study duration: not stated

  • Time points at which follow‐up are reported: from start of treatment until the end of treatment

Participants
  • 30 participants in total: age range between 18‐22 years (14 males and 16 females)

  • 15 in the mini‐screw implant group

  • 15 in the headgear group

  • Inclusion criteria:

  1. bimaxillary anterior protrusion

  2. require maximum anchorage

  3. extraction of all first premolars

Interventions
  • Comparison 1: Mini‐screw implants (AbsoAnchor, Dentos Inc., Daugu, Korea)

  1. 1.2 mm diameter; maxilla 6 mm length, mandible 5 mm length

  2. Placed between the maxillary second premolars and first molars, and between the mandibular first molars and second molars

  3. Loaded immediately with 100 g of force using activated nickel titanium coil springs (Grikin Co., Beijing, China) to retract the anterior teeth

  4. 1‐step retraction of the anterior arch segment was carried out

  • Comparison 2: Headgear (Shinye Odontological Materials Co. Ltd, Hangzhou, China)

  1. Applied during the same period as for the micro‐implant group

  2. Outer face bows were bent upwards at an angle of 20 degrees

  3. A force of 350 g applied until all premolar spaces were closed

  4. 1‐step retraction of the anterior arch segment was carried out

Outcomes No outcomes concerned with this review were reported
Notes Pre‐adjusted straight wire appliances were used with an MBT prescription
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "The subjects were randomly divided (RandA1.0 Software, Planta Medical Technology and Development Co. Ltd, Beijing, China) into two equal groups"
Allocation concealment (selection bias) Unclear risk Not addressed
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "Tracing, superimposition, and measurement were undertaken manually by two examiners who did not participate in the study design"
Comment: blinding of outcome assessment probably achieved because the radiographs were taken before and immediately after treatment; at these points of treatment, the appliances are not fixed inside the mouth, and hence do not show on the radiographs
Incomplete outcome data (attrition bias) 
 mesial movement of upper first maxillary molar Low risk All randomised patients accounted for
Selective reporting (reporting bias) High risk
  • Selective reporting of outcomes: movement of molars was not reported

  • Selective reporting of data: not relevant because no outcomes concerned with this review were reported

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