Miniscrews as Anchorage Device for Orthodontic Treatment
Condition: Orthodontic Anchorage Procedures; Orthodontic Space Closure
Study type: Interventional

Summary: 
      The purpose of this trial is to study and compare two different anchorage techniques.
      Adolescent patients in need for orthodontic treatment are randomized into Group A and B. Both
      groups are treated with extractions of the maxillary first premolars and fixed appliance.
      Anchorage is reinforced by miniscrews in Group A and by molarblock in Group B.

      The hypotheses are:

        -  that placement of miniscrews does not cause more pain or discomfort than premolar
           extractions

        -  that molarblock provides increase of anchorage

        -  that miniscrews have a better anchorage capacity than molarblock

        -  that miniscrews are more cost-efficient than conventional anchorage techniques
    

Detailed description: 
      Participants are recruited from the orthodontic specialist clinic in Gävle, Sweden. After
      informed consent participants are randomized into Group A and B. The treatment starts with
      extractions of the maxillary first premolars. Extractions are performed by the participants´
      general practitioner. Orthodontic treatment starts after the tooth extractions.

      All participants get treatment with fixed appliance according to the straight wire concept
      (3M Victory brackets, .022 slot size, McLaughlin-Bennet-Trevesi prescription). The
      recommended wire sequence is: .016 Heat Activated Nickel Titanium, .019x.025 Heat Activated
      Nickel Titanium, .019x.025 Stainless Steel. Treatment time is about two years.

      The following measurements are taken at:

      T0 (Before treatment start): Study models, baseline questionnaire,

      T1 (after tooth extractions, before the orthodontic treatment): Study models, cephalographic
      x-ray, questionnaire at the evening after tooth extractions, questionnaire one week after
      tooth extractions.

      T2 (After miniscrew placement (Group A), Before space closure): Study models, cephalographic
      x-ray, questionnaire at the evening after miniscrew placement, questionnaire one week after
      miniscrew placement.

      T3 (After space closure and miniscrew removal): Study models, cephalographic x-ray,
      questionnaire after screw removal
    

Intervention name(s): Topical anesthesia (buccal and palatal); Local anesthesia (buccal and palatal); Extraction of the maxillary first premolars; Topical anesthesia (buccal); Local anesthesia (buccal); Molarblock; Spider Screw K1 short neck
Intervention type(s): Drug; Drug; Procedure; Drug; Drug; Device; Device
Intervention description(s): Saliva is removed with a sterile swab followed by application of 5% Lidocaine gel (APL, Sweden) on the gingiva.; Injection of 1,5 ml Xylocaine Dental Adrenaline (Lidocaine hydrochloride 20 mg/ml, adrenaline 12.5 µg/ml, Dentsply Pharmaceutical, Weybridge, Surrey, UK).; Careful extraction of the maxillary first premolars after mobilization.; Saliva is removed with a sterile swab followed by application of 5% Lidocaine gel (APL, Sweden) on the gingiva.; Injection of 0.3 ml Xylocaine Dental Adrenaline (Lidocaine hydrochloride 20 mg/ml, adrenaline 12.5 µg/ml, Dentsply Pharmaceutical, Weybridge, Surrey, UK).; Molarblock is a Stainless steel ligature connecting the maxillary second premolar with the maxillary first and second molar.; The Spider Screw K1 (Health Development Company, Sarcedo, Italy) is a self-drilling and self-tapping screw. Short neck screws (SCR-1508 and SCR-1510) with a diameter of 1.5 mm and length 8 or 10 mm are used.
Other intervention name(s): Anesthesic Jelly (buccal and palatal); Injection (buccal and palatal); Anesthesic Jelly (buccal); Injection (buccal); Temporary anchorage device; TAD; Orthodontic mini-implant
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Miniscrew; Temporary anchorage device (TAD); mini-implants; Miniscrew implant (MSI)