Ozone-therapy in Non-surgical Periodontal Therapy

NCT ID: NCT07202312

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-03
• Study Completion Date: 2024-05-30

Brief 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. 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.

Conditions

Ozone-therapy (O3); Periodontitis; Antimicrobial Ozone Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ozone-therapy after non surgical therapy

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.

Group Type: EXPERIMENTAL

Ozone-therapy after non-surgical therapy

Intervention Type: DEVICE

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.

Non-surgical therapy

In the control group, non-surgical periodontal therapy was performed using both mechanical and manual instrumentation with curettes and ultrasonic devices.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ozone-therapy after non-surgical therapy

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universita di Verona

OTHER

Sponsor Role: lead

Responsible Party

Alessia Pardo

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Alessia Pardo

Verona, Italy, Italy

Countries

Italy

Other Identifiers

698CET

Identifier Type: -

Identifier Source: org_study_id