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

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-19

Study Completion Date

2023-07-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Extraction of the Lower Third Molars

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control Group

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

Group Type NO_INTERVENTION

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

Group Type EXPERIMENTAL

ozone therapy

Intervention Type OTHER

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

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Azienda Ospedaliera Ordine Mauriziano di Torino

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

A.O. Ordine Mauriziano

Torino, , Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Paolo Appendino, Dr.

Role: CONTACT

+390115082222

Lucia Borsotti, dr.ssa

Role: CONTACT

+390115082222

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Paolo Appendino, dr.

Role: primary

+390115082222

Lucia Borsotti, dr.ssa

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

OZONOTERAPIA

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Complications After Lower Third Molar Surgery
NCT03130933 COMPLETED PHASE1/PHASE2