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

Primary Purpose

Extraction of the Lower Third Molars

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
ozone therapy
Sponsored by
Azienda Ospedaliera Ordine Mauriziano di Torino
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Extraction of the Lower Third Molars

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • A.O. Ordine MaurizianoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Trial Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 10, 2023
Last Updated
July 10, 2023
Sponsor
Azienda Ospedaliera Ordine Mauriziano di Torino
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1. Study Identification

Unique Protocol Identification Number
NCT05949476
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 19, 2022 (Actual)
Primary Completion Date
July 1, 2023 (Actual)
Study Completion Date
July 19, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azienda Ospedaliera Ordine Mauriziano di Torino

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extraction of the Lower Third Molars

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
extraction of the lower third molar will be performed according to the standard protocols of the structure
Arm Title
Trial Group
Arm Type
Experimental
Arm 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
Intervention Type
Other
Intervention Name(s)
ozone therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction post operative pain
Description
Evaluate whether the use of ozone in patients undergoing extraction of impacted third molars reduces post-operative pain 7 days after surgery.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paolo Appendino, Dr.
Phone
+390115082222
Email
pappendino@mauriziano.it
First Name & Middle Initial & Last Name or Official Title & Degree
Lucia Borsotti, dr.ssa
Phone
+390115082222
Email
lborsotti@mauriziano.it
Facility Information:
Facility Name
A.O. Ordine Mauriziano
City
Torino
ZIP/Postal Code
10128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paolo Appendino, dr.
Phone
+390115082222
Email
pappendino@mauriziano.it
First Name & Middle Initial & Last Name & Degree
Lucia Borsotti, dr.ssa
Email
lborsotti@mauriziano.it

12. IPD Sharing Statement

Learn more about this trial

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

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