Clinical trial NCT05949476: Influence of Ozone Therapy on Postoperative Pain Relief in the Surgical Treatment of Lower Third Molars: Randomized Controlled Trial
Official title: Influence of Ozone Therapy on Postoperative Pain Relief in the Surgical Treatment of Lower Third Molars: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Extraction of the Lower Third Molars
Lead sponsor: Azienda Ospedaliera Ordine Mauriziano di Torino
Sponsor class: OTHER
First posted: 2023-07-18
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Reduction post operative pain
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Torino
country: Italy
facility: A.O. Ordine Mauriziano
Study officials:
References: