Extraction of the Lower Third MolarsNCT05949476
Influence of Ozone Therapy on Postoperative Pain Relief in the Surgical Treatment of Lower Third Molars: Randomized Controlled Trial
A study testing ozone therapy in people with Extraction of the Lower Third Molars, run by Azienda Ospedaliera Ordine Mauriziano di Torino at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Extraction of the Lower Third Molars
- What is being tested?
- ozone therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteItaly
- Study dates
- 19 Jul 2022to 19 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Lower third molars included
- Pell-Gregory Class II-B
- Absence of systemic diseases
Who cannot join
- Hyperthyroidism;
- G6PHD (glucose 6 phosphate dehydrogenase) deficiency;
- Anemia
- Myasthenia
- Pregnancy and breastfeeding
- Allergy to ozone
- Local infections
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
A.O. Ordine Mauriziano
Torino, 10128
Paolo Appendino, dr., +390115082222, pappendino@mauriziano.it
Lucia Borsotti, dr.ssa, lborsotti@mauriziano.it
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Extraction of the Lower Third Molars
- Being tested
- ozone therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ozone therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | extraction of the lower third molar will be performed according to the standard protocols of the structure |
| Trial Group | Experimental | 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 Receives: Other: ozone therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start19 Jul 2022
- Primary completion1 Jul 2023
- Study completion19 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Extraction of the Lower Third MolarsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Ordine Mauriziano di Torino
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05949476
- Sponsor's protocol ID
- OZONOTERAPIA
- Status last verified
- Jul 2023
- First submitted
- 10 Jul 2023
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guaschino L, Vanzanelli A, Babando P, Ricotti A, Ramieri GA, Roccuzzo A, Appendino P. Effect of ozone therapy on post-operative pain following mandibular third molar surgical extraction: a split-mouth randomized clinical trial. Clin Oral Investig. 2025 Dec 9;30(1):2. doi: 10.1007/s00784-025-06681-y.
PubMed 41361069
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Ozone Therapy on Postoperative Pain Relief in the Surgical Treatment of Lower Third Molars: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05949476
- Acronym / sponsor ID
- OZONOTERAPIA
- Conditions
- Extraction of the Lower Third Molars
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Ordine Mauriziano di TorinoUniversity, hospital or other
- Study start
- 19 Jul 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 19 Jul 2023 (estimated)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –extraction of the lower third molar will be performed according to the standard protocols of the structure |
| Trial Group | Experimental | Other: ozone therapyIn 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 |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Lower third molars included
- Pell-Gregory Class II-B
- Absence of systemic diseases
Key exclusion criteria (7 listed)
- Hyperthyroidism;
- G6PHD (glucose 6 phosphate dehydrogenase) deficiency;
- Anemia
- Myasthenia
- Pregnancy and breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ozone therapyOzone 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. | Other | Trial Group |
Primary outcome
Reduction post operative pain
Time frame: 7 days
Evaluate whether the use of ozone in patients undergoing extraction of impacted third molars reduces post-operative pain 7 days after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Derived from this study: PubMed 41361069Guaschino L, Vanzanelli A, Babando P, Ricotti A, Ramieri GA, Roccuzzo A, Appendino P. Effect of ozone therapy on post-operative pain following mandibular third molar surgical extraction: a split-mouth randomized clinical trial. Clin Oral Investig. 2025 Dec 9;30(1):2. doi: 10.1007/s00784-025-06681-y.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ozone therapy in people with Extraction of the Lower Third Molars, run by Azienda Ospedaliera Ordine Mauriziano di Torino at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paolo Appendino, Dr. (+390115082222, pappendino@mauriziano.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction post operative pain (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05949476, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2023.