Skip to main content
. 2014 Aug 19;2014(8):CD005098. doi: 10.1002/14651858.CD005098.pub3

Chesterfield 2007.

Methods

  • Trial design: 2‐centre RCT (parallel group)

  • Location: Chesterfield and North Derbyshire Royal Hospital NHS Trust and Charles Clifford Dental Hospital, UK

  • Recruitment period: 24 months

  • Funding source: not stated

  • Source of participants: patients attending clinic

  • Study duration: 3.75 years

  • Time points at which follow‐up are reported: before treatment, end of anchorage
Participants

  • 51 (38 female, 13 male), mean age 15.2

  • 25 in mid‐palatal implant group: mean age 15.7 years; 7 males, 18 females

  • 26 in the headgear group: mean age 14.8 years; 6 males, 20 females

  • Inclusion criteria:

  1. absolute anchorage needed

  2. any forward movement of the molars would prevent achievement of an ideal Class 1 canine relationship

  3. various Class 1, Class II division 1, division 2

  • Exclusion criteria:

  1. poor oral hygiene

  2. unwilling to wear fixed appliances

  3. unwilling to wear headgear or have the implant placed

  4. medical history precluding fixed appliance treatment

  5. patients requiring orthognathic surgery
Interventions

  • Comparison 1: Mid‐palatal implants (Orthoimplant, Strauman AG, Waldenburg, Switzerland)

  1. 6 mm mid‐palatal implant surgically placed using a stent

  2. Loaded after 3 months with a laboratory made transpalatal arch connected to the maxillary first molars

  • Comparison 2: Headgear

  1. Headgear with a Nitom locking facebow fitted to bands on the maxillary molars

  2. Variable pull (according to clinical situation) with a force of 450 g on each side and duration of 100‐120 hours/week

  3. A headgear chart was used
Outcomes

  • Anchorage loss measured by mesial molar movement:


‐ measured in mm on cephalometric radiographs using the Pancherz analysis between T1 (treatment start) and T2 (end of anchorage reinforcement)
‐ measured at the end of anchorage (when the anchorage device was no longer needed)

  • Success of anchorage device (failure after orthodontic loading, patients did not end up with implant‐assisted anchorage)

  • Duration of treatment

  • Number of visits per course of treatment

  • Patient perception by measuring discomfort:


‐ questionnaire in which the patients were asked to indicate the grade they would assign to the surgery on a six 6‐point scale where 1 was totally uncomfortable and 6 was comfortable
‐ questionnaire was administered at 3 time points: immediately after placement of the palatal implant, 3 days after placement and upon removal of the palatal implant
Notes

  • Participants were treated by 4 orthodontists in 2 centres

  • A pre‐adjusted edgewise appliance with an MBT prescription was used

  • Other outcome measures were reported not related to this review
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "...randomisation carried out by using computer‐generated random numbers in a block design"
Allocation concealment (selection bias) Low risk Quote: "..randomisation carried out by using computer‐generated random numbers in a block design by a researcher unconnected with the recruitment of most patients"
Quote: "...allocation was concealed in consecutively numbered, sealed opaque envelopes, which were opened after the patient and parent agreed to enter the trial"
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quotes:

  • "all radiographs were made anonymous by obscuring patient details"

  • "implants were concealed by using an opaque marker on both sides of the radiograph"

  • "an opaque marker was also placed in the approximate position of an implant on the radiographs of the headgear group"

  • "the grid and measurement of the radiographs were performed by different researchers"
Incomplete outcome data (attrition bias) 
 mesial movement of upper first maxillary molar Low risk

  • Palatal implant group: 23 out of 25 randomised patients were included in the analysis. 2 patients decided against treatment; 1 moved away and 1's family split up

  • Headgear group: 24 out of 26 randomised patients were included in the analysis. 1 patient moved away before the commencement of treatment, 1 patient had missing follow‐up radiographs
Selective reporting (reporting bias) Low risk

  • Selective reporting of outcomes: "inflammation of the peri‐implant tissues" was an intended outcome. This outcome was not reported because it was not measured

  • Selective reporting of data: data on patient perception was incompletely reported
Other bias Low risk Study appears to be free of other sources of bias