Ozone-therapy in Non-surgical Periodontal Therapy

NCT07202312 | Completed DMC

• 1 other identifier: 698CET
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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

Keywords

ozone therapy; periodontitis

Outcome Measures

Primary Outcomes (2)

• Probing Pocket Depth PPD Index

  Probing depth is the distance from the gingival margin to the base of the pocket (mm)

  [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.

  [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

  [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: 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: 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: T0 (Baseline), T1(7 days after baseline), T2 (14 days after baseline), T3 (1 month after baseline), T4 (3 months after baseline)]

Study Arms (2)

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.

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.

Interventions

Ozone-therapy after non-surgical therapy 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.

Ozone-therapy after non surgical therapy

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

Alessia Pardo

Verona, Italy, 37134, Italy

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 1, 2025
• Study Start: August 3, 2023
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: October 1, 2025

Record last verified: 2023-08

Locations

IT (1)