Impacted teeth
Conditions
Interventions
We propose a clinical trial to test a new photobiomodulation light-emitting diodes (LED) device to enhance the control of the trismus, edema, and pain after extractions of impacted inferior third mola
E06.892
Sponsors
Faculdade de Odontologia da Universidade de São Paulo
Eligibility
Age
16 Years to 35 Years
Inclusion criteria
Inclusion criteria: Healthy patients of both gender, aged between 16 and 35 years, who need extraction of both inferior third molars and that these teeth have similar bone impactions bilaterally, observed by means of panoramic radiography, presenting the same classification of dental impaction of according to Pell & Gregory (1933) and Winter (1926).
Exclusion criteria
Exclusion criteria: Pre or postoperative sensory changes; Use of analgesics or antiinflammatory drugs in the 48 hours prior to extractions; Pregnant or lactating women; Known hypersensitivity to any of the drugs used in the study (Mepivacaine, Amoxicillin, Ibuprofen, Dipyrone, Chlorhexidine); Patients with postoperative infections or alveolitis; Failure to follow postoperative recommendations; Failure to attend postoperative consultations; Technical failure in anesthesia or need to use more than three anesthetic tubes; Surgeries with operative time greater than 40 minutes; Patients with temporomandibular joint dysfunction or limited mouth opening; Individuals who do not have the upper and lower central incisors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome: trismus. Limitation of postoperative mouth opening.The maximum mouth opening recorded before the start of surgery (A0), 24 hours (A1) and 7 days (A2) after the procedure, using a digital caliper. The measurement in millimeters considers the distance between the upper right central incisor and the lower right central incisor. For calculating the postoperative mouth opening limitation, the differences between the 24h and preoperative opening measures are considered. To calculate the improvement in mouth opening, the differences between the measurements of 7 days and 24 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secundary outcome: postoperative edema. With a hypodermic pen, four fixed points marked on the patient's face: tragus (Tr), lateral corner of the eye (Co), labial commissure (Cl) and goniac angle (Ag). With the patient seated and the Frankfurt plane parallel to the ground, with the mandibular resting position and the mouth closed, measured with a flexible measuring tape three linear distances in millimeters (mm): from the tragus to the labial commissure (Tr-Cl), from the goniac angle to the labial commissure (Ag-Cl) and from the goniac angle to the corner of the eye (Ag-Co). These measurements were carried out before the start of surgery (T0) and in the 24 hours and 7 postoperative days. The three linear measures of edema from each evaluation period are added together. For the calculation of postoperative edema, the differences between 24h and preoperative data are considered. For the calculation of edema improvement, differences between the 7-day and 24-hour data are considered. These data are transformed into percentages considering T0 and 24 hours as the values ??of 100% respectively.;Secundary outcome: postoperative pain. Three different measurements are considered: After each of the surgeries, participants receive a questionnaire, through which pain intensity is measured using a visual analog scale (VAS). The scale consists of a 100 mm long straight line with the identification of “no pain” on its left end, which represents the absence of pain and on its right end the word “the worst possible pain”, which represents a strong presence of pain . The patient points out, at different postoperative periods, by a line within the limits of the line, the place that is considered representative of the intensity of his pain. The first measurement is recorded at the end of the sensation of anesthesia (T0), reported by the patient himself, represented by the cessation of tingling in the lips, tongue and tenderness in the teeth, that is, the moment when the patient notic | — |
Countries
Brazil
Contacts
Public ContactVitor Rodrigues
Faculdade de Odontologia da Universidade de São Paulo
Outcome results
None listed