Influence of Ozone Therapy on Postoperative Pain Relief in the Surgical Treatment of Lower Third Molars: Randomized Controlled Trial
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Control Group extraction of the lower third molar will be performed according to the standard protocols of the structure |
|
| Experimental: Trial Group 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
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.
|
Outcome Measures
Primary Outcome Measures
- Reduction post operative pain [7 days]
Evaluate whether the use of ozone in patients undergoing extraction of impacted third molars reduces post-operative pain 7 days after surgery.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Lower third molars included
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Pell-Gregory Class II-B
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Absence of systemic diseases
Exclusion Criteria:
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Hyperthyroidism;
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G6PHD (glucose 6 phosphate dehydrogenase) deficiency;
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Anemia
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Myasthenia
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Pregnancy and breastfeeding
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Allergy to ozone
-
Local infections
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | A.O. Ordine Mauriziano | Torino | Italy | 10128 |
Sponsors and Collaborators
- Azienda Ospedaliera Ordine Mauriziano di Torino
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OZONOTERAPIA