Influence of Ozone Therapy on Postoperative Pain Relief in the Surgical Treatment of Lower Third Molars: Randomized Controlled Trial
NCT ID: NCT05949476
Last Updated: 2023-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
55 participants
INTERVENTIONAL
2022-07-19
2023-07-19
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Control Group
extraction of the lower third molar will be performed according to the standard protocols of the structure
No interventions assigned to this group
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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Pell-Gregory Class II-B
* Absence of systemic diseases
Exclusion Criteria
* G6PHD (glucose 6 phosphate dehydrogenase) deficiency;
* Anemia
* Myasthenia
* Pregnancy and breastfeeding
* Allergy to ozone
* Local infections
18 Years
30 Years
ALL
No
Sponsors
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Azienda Ospedaliera Ordine Mauriziano di Torino
OTHER
Responsible Party
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Locations
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A.O. Ordine Mauriziano
Torino, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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OZONOTERAPIA
Identifier Type: -
Identifier Source: org_study_id
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