Evaluation of the Levels of Pain and Discomfort Associated With Two Techniques of Corticotomy
Condition: Class II Division 1 Malocclusion
MeSH terms: Malocclusion
Study type: Interventional

Summary: 
      This study aims to estimate the levels of pain and discomfort associated with the en-masse
      retraction of the six upper anterior teeth and assisted by either conventional or flapless
      corticotomy.

      Thirty-four adult patients exhibiting class П division 1 malocclusion will be randomly
      allocated to either the conventional corticotomy group or the flapless corticotomy group, and
      they will be treated by extraction of maxillary first premolars with applying mini-screws
      between maxillary second premolar and first molar as temporary skeletal anchorage devices
      (TSADs). The levels of pain and discomfort will be rated after 24 hours of corticotomy (T1),
      four days (T2), seven days (T3), 14 days (T4) and after 28 days of corticotomy, by asking the
      patients to fill in a questionnaire for assessing levels of pain and discomfort.
    

Detailed description: 
      Increasing the treatment duration is one of the most important difficulties facing the
      orthodontist. Several therapeutic procedures accompanying orthodontic treatment have been
      introduced in order to reduce the treatment duration and the most important one is the
      corticotomy. Although traditional corticotomy proved to be effective in accelerating
      different types of tooth movement, it is considered aggressive in nature. Hence, there is an
      interest to develop minimally invasive surgical techniques. These techniques include the
      flapless corticotomy using the piezosurgery device.

      In flapless corticotomy group, vertical soft-tissue incisions will be made on the buccal and
      palatal gingiva. One incision will be made between the roots of the six upper anterior teeth,
      and two incisions will be made between the upper canines and second premolars. The incisions
      will be 5 mm long and started 4 mm apical to the interdental papilla. Then a piezosurgery
      knife will be inserted to perform the cortical alveolar incisions with 3-mm in-depth and 8-mm
      in length. No suturing will be needed.

      In traditional corticotomy group, a full-thickness mucoperiosteal flap will be elevated,
      extended from the distal side of the second premolar on the right side to the same position
      on the left side without performing any vertical releasing incisions. The full-thickness flap
      will be extended 3 mm above the root apices, from the buccal and palatal sides. Then, one
      vertical incision between the roots of upper anterior teeth and two vertical incisions in the
      site of first premolar extraction will be made by the piezosurgery knife. The vertical
      incisions will be connected by a horizontal incision using the piezosurgery knives. The
      vertical incisions will be 3 mm in depth, starting 2-3 mm apical to the alveolar crest, and
      extending 3 mm beyond the root apices. The interrupted technique of suturing will be done
      using a non-absorbent 3-0 black silk.

      The levels of pain and discomfort will be rated after 24 hours of corticotomy (T1), four days
      (T2), seven days (T3), 14 days (T4) and after 28 days of corticotomy, by asking the patients
      to fill in a questionnaire based on the Visual Analogue Scale (VAS), and patient's responses
      will be obtained regarding their feelings of pain, discomfort, swelling, mastication and
      swallowing difficulties, jaw movement restriction, satisfaction and recommend the procedure
      to a friend.
    

Intervention name(s): Traditional corticotomy; Flapless corticotomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Adult patients will be treated by extraction of maxillary first premolars with applying mini-screws between maxillary second premolar and first molar as temporary skeletal anchorage devices (TSADs). Then en-masse retraction associated with traditional corticotomy will be applied.; Adult patients will be treated by extraction of maxillary first premolars with applying mini-screws between maxillary second premolar and first molar as temporary skeletal anchorage devices (TSADs). Then en-masse retraction associated with flapless corticotomy will be applied.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain and discomfort; En-masse; Class II division 1; Extraction; Tooth movement acceleration; Traditional corticotomy; Fapless corticotomy; Mini-screws