Ozone Therapy After Open Flap Debridement in Periodontitis (OFD-OZONE)

April 18, 2026 updated by: Alparslan Dilsiz

The Effect of Adjunctive Ozone Therapy on Clinical Outcomes Following Open Flap Debridement in Patients With Stage III Periodontitis: A Randomized Split-Mouth Clinical Trial

Periodontitis is a chronic inflammatory disease characterized by the destruction of supporting periodontal tissues. Open flap debridement (OFD) is a commonly used surgical approach for the treatment of deep periodontal pockets when non-surgical therapy is insufficient. However, complete elimination of pathogenic microorganisms remains challenging.

Ozone therapy has been proposed as an adjunctive treatment due to its antimicrobial, anti-inflammatory, and wound healing properties. This randomized split-mouth clinical trial aims to evaluate the clinical effectiveness of adjunctive ozone therapy in patients with Stage III periodontitis undergoing OFD.

A total of 24 systemically healthy patients diagnosed with Stage III periodontitis were included in the study. In each patient, one side was randomly assigned to receive OFD combined with ozone therapy (test group), while the contralateral side received OFD alone (control group).

Clinical periodontal parameters, including plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing pocket depth (PPD), and clinical attachment level (CAL), were recorded at baseline and at 6 and 12 months after treatment.

The study aims to determine whether adjunctive ozone therapy improves clinical outcomes compared to conventional OFD alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this study is to evaluate the clinical effects of adjunctive ozone therapy on periodontal parameters following open flap debridement (OFD) in patients with Stage III periodontitis.

Periodontitis is a multifactorial disease associated with microbial biofilms that lead to progressive destruction of the supporting structures of the teeth. Mechanical debridement alone may not completely eliminate subgingival pathogens, particularly in deep periodontal pockets and anatomically complex areas. Therefore, surgical intervention such as OFD is often required to provide better access for debridement and improve clinical outcomes.

Ozone therapy has been increasingly investigated in dentistry due to its antimicrobial, anti-inflammatory, and biostimulatory properties. It has been suggested that ozone may enhance wound healing and reduce microbial load when used as an adjunct to conventional periodontal therapy.

This study was designed as a randomized split-mouth clinical trial. Twenty-four patients diagnosed with Stage III periodontitis were included. Each patient contributed two treatment sites, which were randomly allocated into test and control groups. The test group received OFD combined with ozone application, whereas the control group received OFD alone.

All participants underwent initial periodontal therapy, including oral hygiene instructions and scaling and root planing. Standardized clinical measurements were performed using a periodontal probe with the aid of customized acrylic stents to ensure reproducibility.

The ozone application was performed immediately after surgical debridement in the test group, following the manufacturer's instructions. The control group did not receive ozone therapy.

Clinical parameters including plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing pocket depth (PPD), and clinical attachment level (CAL) were recorded at baseline, 6 months, and 12 months postoperatively.

The primary outcome of the study is the change in probing pocket depth (PPD). Secondary outcomes include changes in clinical attachment level (CAL), bleeding on probing (BOP), gingival index (GI), and plaque index (PI).

Statistical analysis was performed using non-parametric tests, including the Wilcoxon signed-rank test and Mann-Whitney U test, with a significance level set at p < 0.05.

The findings of this study are expected to provide evidence on the potential benefits of adjunctive ozone therapy in improving periodontal treatment outcomes following OFD.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Erzurum, Turkey (Türkiye)
        • Ataturk University Faculty of Dentistry, Department of Periodontology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged between 25 and 65 years
  • Diagnosed with Stage III periodontitis
  • Presence of at least 20 teeth
  • Presence of periodontal pockets ≥5 mm in at least two teeth
  • Indication for open flap debridement
  • Systemically healthy individuals
  • No periodontal treatment within the last 6 months

Exclusion Criteria:

  • Pregnant or breastfeeding women
  • Presence of systemic diseases that may affect periodontal healing
  • Use of antibiotics or anti-inflammatory drugs within the last 6 months
  • Smoking or tobacco use
  • History of periodontal treatment within the last 6 months
  • Patients with poor oral hygiene compliance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ozone Group
Sites treated with open flap debridement combined with adjunctive ozone therapy.
Procedure: Open Flap Debridement
Open flap debridement was performed to gain access to root surfaces for removal of subgingival plaque and calculus in sites with periodontal pockets.
Device: Ozone Therapy
Adjunctive ozone therapy was applied to the test sites following open flap debridement using an ozone delivery device according to the manufacturer's instructions.
Active Comparator: Control Group
Sites treated with open flap debridement alone without adjunctive ozone therapy.
Procedure: Open Flap Debridement
Open flap debridement was performed to gain access to root surfaces for removal of subgingival plaque and calculus in sites with periodontal pockets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Probing Pocket Depth (PPD)
Time Frame: Baseline to 12 months
Probing pocket depth (PPD) will be measured in millimeters using a periodontal probe at baseline and 12 months after treatment. The outcome represents the change in PPD between baseline and follow-up.
Baseline to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Clinical Attachment Level (CAL)
Time Frame: Baseline to 12 months
Clinical attachment level (CAL) will be measured in millimeters at baseline and 12 months to assess changes in periodontal attachment.
Baseline to 12 months
Change in Bleeding on Probing (BOP)
Time Frame: Baseline to 12 months
Bleeding on probing (BOP) will be recorded as the presence or absence of bleeding following probing at baseline and 12 months.
Baseline to 12 months
Change in Gingival Index (GI)
Time Frame: Baseline to 12 months
Gingival index (GI) will be assessed to evaluate gingival inflammation at baseline and 12 months.
Baseline to 12 months
Change in Plaque Index (PI)
Time Frame: Baseline to 12 months
Plaque index (PI) will be recorded to assess oral hygiene status at baseline and 12 months.
Baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alparslan Dilsiz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Actual)

January 25, 2026

Study Completion (Actual)

February 18, 2026

Study Registration Dates

First Submitted

April 18, 2026

First Submitted That Met QC Criteria

April 18, 2026

First Posted (Actual)

April 24, 2026

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 18, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATAUNI-PERIO-OFD-OZONE-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared due to institutional policies and privacy considerations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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