Influence of Ozone Therapy on Postoperative Pain Relief in the Surgical Treatment of Lower Third Molars: Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
Patients will undergo a split-mouth protocol which includes: a control group: in which the extraction of the lower third molar will be performed according to the standard protocols of the structure. A study group: in which ozone will be used in addition, in two formulations: gaseous, injected into the site of the pre- and post-surgery operation, and topical, in the form of a gel, applied at the end of the operation and for home use according to therapeutic scheme prescribed at the time of discharge. Primary objective: To evaluate whether the use of ozone in patients undergoing extraction of impacted third molars reduces post-operative pain 7 days after surgery. Secondary objectives: Evaluate the functional limitation in opening the mouth (trismus) 7 days after surgery. Evaluate if there is a reduced intake of analgesic drugs in the 7 days following the operation. Evaluate the perceived quality of life in the 7 days following the intervention.

Detailed Description
-----------------
Patients will undergo a split-mouth protocol which includes: a control group: in which the extraction of the lower third molar will be performed according to the standard protocols of the structure. A study group: in which ozone will be used in addition, in two formulations: gaseous, injected into the site of the pre- and post-surgery operation, and topical, in the form of a gel, applied at the end of the operation and for home use according to therapeutic scheme prescribed at the time of discharge. Primary objective: To evaluate whether the use of ozone in patients undergoing extraction of impacted third molars reduces post-operative pain 7 days after surgery. Secondary objectives: Evaluate the functional limitation in opening the mouth (trismus) 7 days after surgery. Evaluate if there is a reduced intake of analgesic drugs in the 7 days following the operation. Evaluate the perceived quality of life in the 7 days following the intervention.

Official Title
-----------------
Influence of Ozone Therapy on Postoperative Pain Relief in the Surgical Treatment of Lower Third Molars: Randomized Controlled Trial

Conditions
-----------------
Extraction of the Lower Third Molars

Intervention / Treatment
-----------------
* Other: ozone therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lower third molars included Pell-Gregory Class II-B Absence of systemic diseases Exclusion Criteria: Hyperthyroidism; G6PHD (glucose 6 phosphate dehydrogenase) deficiency; Anemia Myasthenia Pregnancy and breastfeeding Allergy to ozone Local infections

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>extraction of the lower third molar will be performed according to the standard protocols of the structure | |
| Experimental: Trial Group<br>In this group ozone will be used, in two formulations: gaseous, injected into the site of the pre- and post-surgery operation, and topical, in the form of a gel, applied at the end of the operation and for home use according to the therapeutic scheme prescribed at the time of resignation | Other: ozone therapy<br>* Ozone in the gaseous state produced by a machine at concentrations for medical use (sssssssssss9) injected after anesthesia in the surgery site and in the post-extraction alveolus after suture. Topical ozone in the form of a gel (indicate the brand) to be applied to the post-surgical site 2 times a day for 7 days.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction post operative pain | Evaluate whether the use of ozone in patients undergoing extraction of impacted third molars reduces post-operative pain 7 days after surgery. | 7 days |