Ozone-therapy (O3)PD-OZONENCT07202312
Ozone-therapy in Non-surgical Periodontal Therapy
A study testing Ozone-therapy after non-surgical therapy in people with Ozone-therapy (O3) and Periodontitis, run by Universita di Verona at 1 site in Italy.
Trial summary
Non-surgical periodontal therapy is a widely adopted procedure for the treatment of periodontitis, particularly in its moderate to severe stages. The approach involves the mechanical and manual debridement of subgingival biofilm and calculus through the use of ultrasonic scalers and hand curettes. Read more about this study
- Who is it for?
- Ages 18 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Ozone-therapy (O3), Periodontitis, Antimicrobial Ozone Therapy
- What is being tested?
- Ozone-therapy after non-surgical therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2025to 30 Jan 2026
- 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 84 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18 and 84 years; Good general health status; Diagnosis of severe periodontitis involving at least 30% of all teeth, with at least three non-adjacent teeth presenting three sites with probing pocket depth (PPD) greater than 4 mm in at least two quadrants, and having lost at least four teeth due to periodontitis; Presence of at least 16 teeth, with a minimum of four teeth per quadrant.
Who cannot join
- Pregnancy or breastfeeding; Presence of decompensated systemic diseases that may compromise the outcomes of the study or the patient's health; Regular use of antibiotics; Regular use of anti-inflammatory drugs (NSAIDs, corticosteroids, or aspirin); Use of anticoagulant medications; History of systemic antibiotic therapy within six months prior to enrollment; History of any periodontal therapy within six months prior to enrollment; Presence of severe mental or cognitive disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Microbiological Efficacy of Ozone Therapy in the Non-surgical Treatment of Periodontal Disease
Non-surgical periodontal therapy is a widely adopted procedure for the treatment of periodontitis, particularly in its moderate to severe stages. The approach involves the mechanical and manual debridement of subgingival biofilm and calculus through the use of ultrasonic scalers and hand curettes. This method aims to disrupt the pathogenic bacterial load within periodontal pockets and promote clinical attachment gain while reducing inflammation. However, the mechanical removal of biofilm alone may not always ensure complete bacterial eradication, especially in deep or anatomically complex sites.
To enhance bacterial disinfection and optimize clinical outcomes, the adjunctive use of ozone therapy has been introduced. This is a non-invasive technique that employs ozone in gaseous form to eliminate bacteria and fungi, inactivate viruses, and control bleeding. Its antiviral efficacy results from the denaturation of envelope proteins, impairment of viral adhesion to host cells, oxidation of unsaturated fatty acids within the lipid envelope, and degradation of single-stranded RNA. The synergistic effect of combining conventional non-surgical periodontal therapy with ozone therapy enables more thorough decontamination of periodontal pockets, even in cases where systemic antibiotics prove ineffective.
The aim of this study is to evaluate the clinical efficacy of adjunctive ozone therapy following non-surgical periodontal treatment in patients with severe periodontitis. The protocol consists of initial subgingival instrumentation using ultrasonic and manual tools, followed by the application of ozone therapy. The working hypothesis of this study is that the addition of ozone therapy provides superior bacterial reduction and improved clinical outcomes compared to mechanical therapy alone.
- Being tested
- Ozone-therapy after non-surgical therapy
- Keywords
- ozone therapy, periodontitis
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ozone-therapy after non-surgical therapyDevice
The test group received ozone therapy immediately after non-surgical treatment, at a fixed concentration of 2100 ppm and 80% oxygen, applied three times at the site. Ozone was delivered into the periodontal pocket using a sterile syringe with a flat tip. Ozone was generated with the Ozone DTA Ozone Generator (Denta Tec Dental AS, Norway), which was operated for 20 seconds in accordance with the manufacturer's instructions.
| Study group | Role | What they receive |
|---|---|---|
| Ozone-therapy after non surgical therapy | Experimental | The test group received ozone therapy immediately after non-surgical treatment, at a fixed concentration of 2100 ppm and 80% oxygen, applied three times at the site. Ozone was delivered into the periodontal pocket using a sterile syringe with a flat tip. Ozone was generated with the Ozone DTA Ozone Generator (Denta Tec Dental AS, Norway), which was operated for 20 seconds in accordance with the manufacturer's instructions. Receives: Device: Ozone-therapy after non-surgical therapy |
| Non-surgical therapy | No intervention | In the control group, non-surgical periodontal therapy was performed using both mechanical and manual instrumentation with curettes and ultrasonic devices. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing Pocket Depth PPD Index
Probing depth is the distance from the gingival margin to the base of the pocket (mm)
Measured: [Time Frame: T0 (Baseline), T1(7 days after baseline), T2 (14 days after baseline), T3 (45 days after basline), T4 (3 months after baseline)]
Microbiological analysis
The microbiological analysis qualitatively (yes/no) assesses the presence of six types of periodontopathogenic bacteria (Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Tannerella forsythia, Treponema denticola, Actinomyces naeslundii) using sterile paper points inserted into the periodontal pocket prior to non-surgical periodontal therapy. For each site analyzed, two saliva samples are collected: one is placed in a test tube containing ethanol, and the other in a tube containing ammonium thioglycolate. The samples are subsequently transported to the microbiology department of the Integrated University Hospital of Verona for analysis.
Measured: [Time Frame: T0 (Baseline), T2 (14 days after baseline), T3 (45 days after basline), T4 (3 months after baseline)]
Secondary outcomes (4)
Recession REC Index
Recession is the apical shift of the marginal tissues associated with the attachment loss exposing the root or implant surface to the oral environment (mm)
Measured: [Time Frame: T0 (Baseline), T1(7 days after baseline), T2 (14 days after baseline), T3 (45 days after basline), T4 (3 months after baseline)]
Clinical attachment level CAL Index
measured in mm as distance from the CEJ to the gingival margin (GM)
Measured: [Time Frame: T0 (Baseline), T1(7 days after baseline), T2 (14 days after baseline), T3 (45 days after basline), T4 (3 months after baseline)]
Plaque Index
This index ascertains the thickness of plaque along the gingival margin (%)
Measured: [Time Frame: T0 (Baseline), T1(7 days after baseline), T2 (14 days after baseline), T3 (1 month after baseline), T4 (3 months after baseline)]
Bleeding on probing BOP Index
is an indicator of tissue inflammatory response to bacterial pathogens (%)
Measured: [Time Frame: T0 (Baseline), T1(7 days after baseline), T2 (14 days after baseline), T3 (1 month after baseline), T4 (3 months after baseline)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start1 Oct 2025
- Primary completion30 Dec 2025
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ozone-therapy (O3)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessia Pardo, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07202312
- Sponsor's protocol ID
- 698CET
- Acronym
- PD-OZONE
- Status last verified
- May 2026
- First submitted
- 23 Sep 2025
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Microbiological Efficacy of Ozone Therapy in the Non-surgical Treatment of Periodontal Disease
- ClinicalTrials.gov ID
- NCT07202312
- Acronym / sponsor ID
- PD-OZONE / 698CET
- Keywords
- ozone therapy, periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 1 Oct 2025 (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.
Non-surgical periodontal therapy is a widely adopted procedure for the treatment of periodontitis, particularly in its moderate to severe stages. The approach involves the mechanical and manual debridement of subgingival biofilm and calculus through the use of ultrasonic scalers and hand curettes. This method aims to disrupt the pathogenic bacterial load within periodontal pockets and promote clinical attachment gain while reducing inflammation. However, the mechanical removal of biofilm alone may not always ensure complete bacterial eradication, especially in deep or anatomically complex sites.
To enhance bacterial disinfection and optimize clinical outcomes, the adjunctive use of ozone therapy has been introduced. This is a non-invasive technique that employs ozone in gaseous form to eliminate bacteria and fungi, inactivate viruses, and control bleeding. Its antiviral efficacy results from the denaturation of envelope proteins, impairment of viral adhesion to host cells, oxidation of unsaturated fatty acids within the lipid envelope, and degradation of single-stranded RNA. The synergistic effect of combining conventional non-surgical periodontal therapy with ozone therapy enables more thorough decontamination of periodontal pockets, even in cases where systemic antibiotics prove ineffective.
The aim of this study is to evaluate the clinical efficacy of adjunctive ozone therapy following non-surgical periodontal treatment in patients with severe periodontitis. The protocol consists of initial subgingival instrumentation using ultrasonic and manual tools, followed by the application of ozone therapy. The working hypothesis of this study is that the addition of ozone therapy provides superior bacterial reduction and improved clinical outcomes compared to mechanical therapy alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ozone-therapy after non surgical therapy | Experimental | Device: Ozone-therapy after non-surgical therapyThe test group received ozone therapy immediately after non-surgical treatment, at a fixed concentration of 2100 ppm and 80% oxygen, applied three times at the site. Ozone was delivered into the periodontal pocket using a sterile syringe with a flat tip. Ozone was generated with the Ozone DTA Ozone Generator (Denta Tec Dental AS, Norway), which was operated for 20 seconds in accordance with the manufacturer's instructions. |
| Non-surgical therapy | No intervention | –In the control group, non-surgical periodontal therapy was performed using both mechanical and manual instrumentation with curettes and ultrasonic devices. |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age between 18 and 84 years; Good general health status; Diagnosis of severe periodontitis involving at least 30% of all teeth, with at least three non-adjacent teeth presenting three sites with probing pocket depth (PPD) greater than 4 mm in at least two quadrants, and having lost at least four teeth due to periodontitis; Presence of at least 16 teeth, with a minimum of four teeth per quadrant.
Key exclusion criteria (1 listed)
- Pregnancy or breastfeeding; Presence of decompensated systemic diseases that may compromise the outcomes of the study or the patient's health; Regular use of antibiotics; Regular use of anti-inflammatory drugs (NSAIDs, corticosteroids, or aspirin); Use of anticoagulant medications; History of systemic antibiotic therapy within six months prior to enrollment; History of any periodontal therapy within six months prior to enrollment; Presence of severe mental or cognitive disorders.
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-therapy after non-surgical therapyThe test group received ozone therapy immediately after non-surgical treatment, at a fixed concentration of 2100 ppm and 80% oxygen, applied three times at the site. Ozone was delivered into the periodontal pocket using a sterile syringe with a flat tip. Ozone was generated with the Ozone DTA Ozone Generator (Denta Tec Dental AS, Norway), which was operated for 20 seconds in accordance with the manufacturer's instructions. | Device | Ozone-therapy after non surgical therapy |
Primary outcome
Probing Pocket Depth PPD Index
Time frame: [Time Frame: T0 (Baseline), T1(7 days after baseline), T2 (14 days after baseline), T3 (45 days after basline), T4 (3 months after baseline)]
Probing depth is the distance from the gingival margin to the base of the pocket (mm)
Microbiological analysis
Time frame: [Time Frame: T0 (Baseline), T2 (14 days after baseline), T3 (45 days after basline), T4 (3 months after baseline)]
The microbiological analysis qualitatively (yes/no) assesses the presence of six types of periodontopathogenic bacteria (Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Tannerella forsythia, Treponema denticola, Actinomyces naeslundii) using sterile paper points inserted into the periodontal pocket prior to non-surgical periodontal therapy. For each site analyzed, two saliva samples are collected: one is placed in a test tube containing ethanol, and the other in a tube containing ammonium thioglycolate. The samples are subsequently transported to the microbiology department of the Integrated University Hospital of Verona for analysis.
4 secondary outcomes
Recession REC Index
Time frame: [Time Frame: T0 (Baseline), T1(7 days after baseline), T2 (14 days after baseline), T3 (45 days after basline), T4 (3 months after baseline)]
Clinical attachment level CAL Index
Time frame: [Time Frame: T0 (Baseline), T1(7 days after baseline), T2 (14 days after baseline), T3 (45 days after basline), T4 (3 months after baseline)]
Plaque Index
Time frame: [Time Frame: T0 (Baseline), T1(7 days after baseline), T2 (14 days after baseline), T3 (1 month after baseline), T4 (3 months after baseline)]
Bleeding on probing BOP Index
Time frame: [Time Frame: T0 (Baseline), T1(7 days after baseline), T2 (14 days after baseline), T3 (1 month after baseline), T4 (3 months after baseline)]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 after non-surgical therapy in people with Ozone-therapy (O3) and Periodontitis, run by Universita di Verona 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 29 May 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing Pocket Depth PPD Index (time frame: [Time Frame: T0 (Baseline), T1(7 days after baseline), T2 (14 days after baseline), T3 (45 days after basline), T4 (3 months after baseline)]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2026.