MedPath

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

Not Applicable
Recruiting
Conditions
Extraction of the Lower Third Molars
Interventions
Other: ozone therapy
Registration Number
NCT05949476
Lead Sponsor
Azienda Ospedaliera Ordine Mauriziano di Torino
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
55
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Trial Groupozone therapyIn 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
Primary Outcome Measures
NameTimeMethod
Reduction post operative pain7 days

Evaluate whether the use of ozone in patients undergoing extraction of impacted third molars reduces post-operative pain 7 days after surgery.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

A.O. Ordine Mauriziano

🇮🇹

Torino, Italy

© Copyright 2025. All Rights Reserved by MedPath