Pain, Discomfort, and Acceptance During Using Electrical Stimulation to Accelerate Orthodontic Teeth Movement
Condition: Class II Malocclusion, Division 1
MeSH terms: Malocclusion; Malocclusion, Angle Class II; Overbite
Study type: Interventional

Summary: 
      Forty patients with class II division 1 malocclusion who will require extraction of the upper
      first premolars as a part of the orthodontic treatment plan will be invited to participate in
      the study. They will be divided randomly into two groups: the electrical group and the
      control group. The en-masse retraction technique will be used to retract the upper anterior
      teeth using mini-implants as an anchor unit to provide the maximum anchorage and
      Nickle-Titanium closed coil springs that will be stretched from the mini-implants to the
      crimpable hooks on the base wire and applied 250 g of force per side.

      A special removable electrical device will be used to provide electrical stimulation during
      the retraction phase.

      The levels of pain and discomfort will be self-reported using a questionnaire with visual
      analog scales.
    

Detailed description: 
      Participants will be chosen from the patients attending the Department of Orthodontics in the
      Faculty of Dentistry at Damascus University. patients will be examined by the researcher, and
      any patient with class II division I malocclusion who meets the inclusion criteria will
      invite to participate in this trial. After giving them the information sheet, informed
      consent will be obtained from all patients who agreed to join the study.

      Leveling and alignment will be performed using pre-adjusted fixed orthodontic appliances of
      0.022 x 0.028-inch slot metal bracket with MBT prescription; the conventional wiring sequence
      will be followed until a 0.019 x 0.025 Stainless Steel base wire is attached.

      The maxillary first premolars will be extracted, and skeletal anchoring will be applied
      before leveling and alignment will begin for all patients. self-drilling orthodontic
      mini-implants (diameter: 1.6 mm; length: 8 mm) will be placed between the roots of the
      maxillary second premolar and the first molar on each side.

      The en-masse retraction will be done using Nickle-Titanium (NiTi) closed coil springs that
      stretched from crimpable hooks on the base wire to the mini-implants and applied 250 g of
      force per side. The force will be examined using a force gauge at every appointment (two
      weeks) until the completion of the retraction of the upper anterior (reaching a class I
      canine relationship and a correct incisor relationship).

      A micro electrical current will be applied on the upper anterior teeth area using a removable
      intraorally device containing a small electrical circuit. Each patient in the experimental
      group will be asked to apply the electric accelerating device in the mouth for 5 hours daily.

      The levels of pain and discomfort will be self-reported using a questionnaire with visual
      analog scales. 24 hours following the springs activation (T1), three days (T2), and one week
      (T3).
    

Intervention name(s): Electrical stimulation; Traditional retraction of the front upper teeth
Intervention type(s): Device; Procedure
Intervention description(s): A specific device will be used to stimulate the remodeling procedures in the alveolar bone.; The retraction will be performed using coil springs which will help in moving the anterior teeth backward without the need to employ any additional procedure or device to accelerate this movement.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Retraction of upper anterior teeth; Electrical stimulation; Coil springs