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

Azienda Ospedaliera Ordine Mauriziano di Torino

Status: Enrolling

Conditions: Extraction of the Lower Third Molars

Treatments: Other: ozone therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05949476

OZONOTERAPIA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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55 participants in 2 patient groups

Control Group

No Intervention group

Description:

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

Trial Group

Experimental group

Description:

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

Treatment:

Other: ozone therapy