NCT05949476

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Azienda Ospedaliera Ordine Mauriziano di Torino · Academic / Other
• Sex: All
• Age: 18 Years – 30 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Extraction of the Lower Third Molars

Interventions

Type	Name	Description
OTHER	ozone therapy	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.

Timeline

• Start date: 2022-07-19
• Primary completion: 2023-07-01
• Completion: 2023-07-19
• First posted: 2023-07-18
• Last updated: 2023-07-18

Locations

1 site across 1 country: Italy