Evaluation of the Effectiveness of the Use of the Therapeutic Bandage Method in Third Molar Surgery
Condition: Pain
Study type: Interventional

Summary: 
      Extraction of lower third molars semi-included or included is one of the most performed
      procedures in oral surgery, and inherent to the procedure there is a postoperative
      inflammatory response. Among the factors most routine to this response are pain, edema and
      trismus. The therapy taping has advantages in its use in the physiotherapy of several
      specialities, leading to the correction of muscular functions, reduction of edema, muscular
      spasms and reduction of pain. Thus, the objective of this split mouth, randomized, blind,
      clinical trial will be to evaluate the postoperative period of 32 third molars in the
      patients from the São Paulo State University (Unesp), Institute of Science and Technology,
      São José dos Campos, Brasil. These evaluations will be performed on the third and seventh
      days after the extraction, where the patients will be analyzed by evaluator who will measure
      the edema, the opening of the mouth (evaluation of muscle spasm) and collect the pain table
      delivered in the immediate postoperative period, comparing thus, the benefit of therapeutic
      banding in the postoperative period of the extraction of lower third molars. The analogue
      pain scale (VAS), together with the Ustün et al. (2003) and the millimeter rule will be used
      to compare the data and the results will be submitted to descriptive statistics and compared
      by means of the statistical analysis of variance (ANOVA) and Tukey test with significance
      level of 5%.
    

Detailed description: 
      Extraction of third molars is the procedure of oral and maxillofacial surgery most commonly
      performed around the world, usually at the outpatient level. Its execution may result in the
      appearance of reversible and / or irreversible disorders, but the most observed signs and
      symptoms are pain, edema and trismus to a greater or lesser degree. Thus, there seems to be
      no consensus within the literature for a better type of post-surgical treatment that leads to
      less patient discomfort when undergoing this kind of surgery.

      The objective of this randomized, blinded trial will be to evaluate the use of therapeutic
      bandaging, Therapy Tex ©, In reducing the signs and symptoms inherent to the postoperative
      period of the third molar extracts, semi-included or included .

      The sample will consist of 32 lower third molars, semi-inclusively or included, divided into
      two groups simultaneously, namely:

      Group I (16 teeth) - without therapeutic bandaging on face. Group II (16 teeth) - with
      therapeutic bandaging on face. The therapeutic bandaging method will be applied in the
      patients of group II, according to the previous randomization.The bandage will be applied
      immediately after surgery and before the end of the anesthetic effect. The skin should be
      cleaned with 70% alcohol in order to remove residue and oiliness, and then should be dried.
      If necessary, scrape the hairs of the region in which the tape will rest. The application of
      the bandage will be in the proposed regions using the "I" cutout, in which no additional
      trimming is made on the tape. The length may vary depending on the size of the patient's
      face. After being applied the bandage should be gently wiped to activate the acrylic
      components that generate adhesiveness and should remain on the face for 3 days.

      The patient is asked to occlude, the dimension of the masseter muscle is determined by
      palpation. During palpation, point A is selected in the lower portion of the zygomatic arch
      and point B is close to the angle of the mandible. The tape will be placed along the
      direction of the muscle fibers.

      Placement of the second tape will occur from the mandibular angle to the mental symphysis,
      accompanying the entire mandibular body in its medial portion covering the milo-hyoid muscles
      and the anterior belly of the digastric.

      The results of the clinical evaluations will be submitted to descriptive statistics and
      compared by means of the statistical analysis of variance (ANOVA) and Tukey test with
      significance level of 5%.
    

Intervention name(s): Group I; Group II
Intervention type(s): Procedure; Procedure
Intervention description(s): Extraction third molar without the application of therapeutic bandaging in the face and with evaluation of edema, pain and trismus; Extraction third molar with the application of therapeutic bandaging in the face and with evaluation of edema, pain and trismus
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The sample will consist of 32 lower third molars, semi-inclusively or included. This study will be a randomized, blind, controlled, split-mouth clinical trial, divided into two groups simultaneously, namely:
Group I (16 teeth) - without therapeutic banding on the face, after the third molar extraction.
Group II (16 teeth) - with therapeutic banding on the face, after the third molar extraction.
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Third molar;; Oral surgery;; Pain;; Edema;; Trismus.