Trsimus
Conditions
Interventions
This is a randomized, controlled, two-arm, triple-blind clinical study with a split-mouth design. Experimental group: 40 patients of both sexes, requiring bilateral third molar extraction, will receiv
and "
Intervention 2,"
corresponding, respectively, to the Placebo Group and the Ozone Therapy Group, to determine which intervention will be performed first on each participant. Each participant will undergo two surgical p
Sponsors
Universidade Estadual Vale do Acaraú
Universidade Federal do Ceará
Eligibility
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: This study will include patients seeking treatment for third molar extraction. To participate, patients must be healthy; between 18 and 40 years old; without systemic alterations or comorbidities and present with two third molars located in the same arch; with similar positions according to the Peel and Gregory Classification and with complete root formation
Exclusion criteria
Exclusion criteria: Glucose-6-phosphate dehydrogenase deficiency (favism); pregnancy; hyperthyroidism; history of heart attack; anemia; pericoronitis in the tooth to be extracted; or use of medications related to inflammation or pain are all exclusionary factors. In addition; patients will be advised to avoid alcohol or drug use in the 24 hours preceding surgery; these factors also exclude them from the sample. The need for third molar extraction will be confirmed by panoramic radiography and participation in the study will be determined after a clinical examination by the responsible surgeon
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: It is expected that there will be a reduction in the intensity of postoperative pain in patients undergoing bilateral third molar extraction treated with ozone therapy compared to the placebo protocol, verified by means of the Visual Analogue Scale, based on the comparison of pain scores obtained in the immediate preoperative period, immediate postoperative period, 72 hours after surgery and at the time of suture removal, as well as by the reduction in the consumption of analgesic medications recorded daily during postoperative follow-up.;Outcome found 1: A reduction in the intensity of postoperative pain was observed in patients undergoing ozone therapy compared to the placebo protocol, verified by means of the Visual Analog Scale in the different periods of clinical evaluation, associated with a reduction in the consumption of analgesic medications during postoperative follow-up, demonstrating a statistically significant difference between the interventions (p < 0.05). | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 2: It is expected to find less limitation of mouth opening after bilateral third molar extraction in patients treated with ozone therapy, verified by measuring the interincisal distance using a digital caliper before surgery and during postoperative follow-up, observing a greater range of mouth opening compared to the placebo protocol.;Outcome found 2: Greater mouth opening amplitude was observed in patients undergoing ozone therapy compared to the placebo protocol, verified by measuring the interincisal distance using a digital caliper during postoperative follow-up, with a statistically significant difference between the interventions at the end of the evaluation period (p < 0.05).;Expected outcome 3: A reduction in the consumption of analgesic medications in the postoperative period is expected in patients undergoing ozone therapy, verified through daily recording of the quantity of medications consumed during telephone follow-up, with a lower number of tablets observed compared to the placebo protocol.;Outcome found 3: Lower consumption of analgesic medications was observed among patients undergoing ozone therapy compared to the placebo protocol, verified through daily recording of the amount of medication consumed during telephone follow-up, showing a statistically significant difference between the interventions (p < 0.05). | — |
Countries
BR
Contacts
Public ContactPoliana Bastos
Universidade Federal do Ceará
Outcome results
None listed