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Ozone-therapy in Non-surgical Periodontal Therapy

NCT07202312 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2025-10-01

No results posted yet for this study

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

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Universita di Verona

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-03
Primary Completion
2024-05-30
Completion
2024-05-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07202312 on ClinicalTrials.gov