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

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.

Study Overview

• Status: Recruiting
• Conditions: Extraction of the Lower Third Molars
• Intervention / Treatment: Other: ozone therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 55
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paolo Appendino, dr.; Phone Number: +390115082222; Email: pappendino@mauriziano.it
• Study Contact Backup: Name: Lucia Borsotti, dr.ssa; Phone Number: +390115082222; Email: lborsotti@mauriziano.it

Study Locations

• Italy
  • Torino, Italy, 10128
    • Recruiting
    • A.O. Ordine Mauriziano
    • Contact: Paolo Appendino, dr.; Phone Number: +390115082222; Email: pappendino@mauriziano.it
    • Contact: Lucia Borsotti, dr.ssa; Email: lborsotti@mauriziano.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; extraction of the lower third molar will be performed according to the standard protocols of the structure
Experimental: Trial Group; 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; 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.

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

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Ordine Mauriziano di Torino

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2022
• Primary Completion (Actual): July 1, 2023
• Study Completion (Estimated): July 19, 2023

Study Registration Dates

• First Submitted: July 10, 2023
• First Submitted That Met QC Criteria: July 10, 2023
• First Posted (Actual): July 18, 2023

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 10, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: OZONOTERAPIA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No