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Completed

NCT Number: NCT07551297

Ozone Therapy After Open Flap Debridement in Periodontitis

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.

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Key information

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ataturk University Faculty of Dentistry, Department of Periodontology

Erzurum, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Open Flap debridement

Procedure

Open flap debridement was performed to gain access to root surfaces for removal of subgingival plaque and calculus in sites with periodontal pockets.

Ozone therapy

Device

Adjunctive ozone therapy was applied to the test sites following open flap debridement using an ozone delivery device according to the manufacturer's instructions.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Alparslan Dilsiz

Other

Registry information

Official study title

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

Acronym: OFD-OZONE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 24, 2026
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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