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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05949476
Enrollment
55
Registered
2023-07-18
Start date
2022-07-19
Completion date
2023-07-19
Last updated
2023-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extraction of the Lower Third Molars

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.

Interventions

OTHERozone 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.

Sponsors

Azienda Ospedaliera Ordine Mauriziano di Torino
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Reduction post operative pain7 daysEvaluate whether the use of ozone in patients undergoing extraction of impacted third molars reduces post-operative pain 7 days after surgery.

Countries

Italy

Contacts

Primary ContactPaolo Appendino, Dr.
pappendino@mauriziano.it+390115082222
Backup ContactLucia Borsotti, dr.ssa
lborsotti@mauriziano.it+390115082222

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026