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

NCT05949476 | Unknown

• 1 other identifier: OZONOTERAPIA
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Extraction of the Lower Third Molars

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Control Group

NO INTERVENTION

extraction of the lower third molar will be performed according to the standard protocols of the structure

Trial Group

EXPERIMENTAL

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

Interventions

ozone therapy OTHER

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.

Trial Group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Lower third molars included
• Pell-Gregory Class II-B
• Absence of systemic diseases

You may not qualify if:

• Hyperthyroidism;
• G6PHD (glucose 6 phosphate dehydrogenase) deficiency;
• Anemia
• Myasthenia
• Pregnancy and breastfeeding
• Allergy to ozone
• Local infections

Sponsors & Collaborators

• Azienda Ospedaliera Ordine Mauriziano di Torino: lead

Study Sites (1)

A.O. Ordine Mauriziano

Torino, 10128, Italy

RECRUITING

Related Publications (1)

• Guaschino L, Vanzanelli A, Babando P, Ricotti A, Ramieri GA, Roccuzzo A, Appendino P. Effect of ozone therapy on post-operative pain following mandibular third molar surgical extraction: a split-mouth randomized clinical trial. Clin Oral Investig. 2025 Dec 9;30(1):2. doi: 10.1007/s00784-025-06681-y.

  PMID: 41361069 DERIVED

Central Study Contacts

Paolo Appendino, Dr.

CONTACT

+390115082222; pappendino@mauriziano.it

Lucia Borsotti, dr.ssa

CONTACT

+390115082222; lborsotti@mauriziano.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: July 18, 2023
• Study Start: July 19, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 19, 2023
• Last Updated: July 18, 2023

Record last verified: 2023-07

Locations

IT (1)