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Completed

NCT Number: NCT07604636

Adjunctive Ozone Therapy for Residual Periodontal Pockets

Patients with residual periodontal pockets following non-surgical periodontal therapy remain at risk for disease progression and may require further periodontal surgery. Repeated scaling and root planing (SRP) is commonly used for residual pockets; however, complete elimination of periodontal pathogens is often difficult to achieve. Ozone therapy has antimicrobial, anti-inflammatory, and wound-healing properties that may improve periodontal treatment outcomes.

The aim of this randomized controlled clinical trial is to clinically and microbiologically evaluate the adjunctive effects of gaseous ozone application during repeated SRP for residual periodontal pockets in patients undergoing periodontal maintenance therapy. Twenty-six patients diagnosed with stage III or IV periodontitis presenting with residual periodontal pockets ≥5 mm with bleeding on probing will be included. Residual pockets will be randomly assigned to either repeated SRP alone (control group) or repeated SRP combined with ozone application (test group).

Clinical periodontal parameters and microbiological findings will be evaluated at baseline, 3 months, and 6 months after treatment.

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Key information

Age range

18 year and older

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

Periodontitis is a chronic multifactorial inflammatory disease associated with dysbiotic subgingival biofilm and progressive destruction of tooth-supporting tissues. Although scaling and root planing (SRP) represents the gold standard of non-surgical periodontal therapy, residual periodontal pockets may persist after treatment, especially in patients with stage III and IV periodontitis. Residual pockets ≥5 mm with bleeding on probing are associated with increased risk of disease recurrence and often require additional interventions.

Adjunctive therapeutic approaches have been proposed to improve outcomes of non-surgical periodontal treatment. Ozone therapy has attracted increasing interest in periodontology because of its antimicrobial, anti-inflammatory, antihypoxic, immunomodulatory, and wound-healing effects. However, evidence regarding the adjunctive use of ozone in residual periodontal pockets remains limited.

This study was designed as a split-mouth, randomized-controlled, double-blind clinical trial with a 6-month follow-up period. Twenty-six systemically healthy individuals diagnosed with stage III or IV periodontitis and undergoing periodontal maintenance therapy will be included. Patients presenting with residual periodontal pockets ≥5 mm with bleeding on probing following previous non-surgical periodontal treatment will be enrolled.

Residual periodontal pockets will be randomly assigned to one of the following groups:

Control group: repeated scaling and root planing alone Test group: repeated scaling and root planing combined with gaseous ozone application

Clinical periodontal measurements including plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing depth (PD), recession depth (RD), and clinical attachment level (CAL) will be recorded using a standardized acrylic stent and a UNC-15 periodontal probe. Microbiological evaluation will be performed using the benzoyl-DL-arginine naphthylamide (BANA) enzymatic assay.

Ozone application will be performed using the OzoneDTA device with a periodontal probe tip according to the manufacturer's instructions. Clinical and microbiological evaluations will be performed at baseline, 3 months, and 6 months.

The primary objective of this study is to evaluate whether adjunctive ozone application improves clinical periodontal outcomes in residual periodontal pockets compared with repeated SRP alone.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Systemically healthy individuals
  • Patients diagnosed with stage III or IV periodontitis
  • Patients undergoing periodontal maintenance therapy
  • Presence of at least two residual periodontal pockets ≥5 mm with bleeding on probing
  • Presence of radiographic bone loss ≥3 mm
  • Plaque Index (PI) <1 before treatment
  • Ability and willingness to attend all follow-up visits
  • Written informed consent obtained

Exclusion criteria

  • Presence of systemic diseases affecting periodontal healing
  • Pregnancy or lactation
  • Tobacco or alcohol use
  • Use of medications affecting periodontal tissues or wound healing
  • Periodontal treatment within the previous 6 months
  • Presence of carious lesions or periapical pathology on selected teeth
  • Furcation involvement
  • Tooth mobility ≥ degree 1
  • Restorations on selected teeth

Treatment and study plan

Scaling and Root Planing

Procedure

Repeated scaling and root planing of residual periodontal pockets was performed using mini-curettes under local anesthesia following periodontal maintenance therapy.

Other names: Subgingival Reinstrumentation

Gaseous Ozone Application

Device

Gaseous ozone was applied into residual periodontal pockets using the OzoneDTA device with a periodontal probe tip according to the manufacturer's instructions.

Other names: Ozone Therapy

Primary outcomes

  1. Change in Probing Depth

    Time frame: Baseline, 3 months, and 6 months after treatment

    Assessment of changes in periodontal probing depth (PD) in residual periodontal pockets following repeated scaling and root planing with or without adjunctive gaseous ozone application.

Secondary outcomes

  1. Change in Clinical Attachment Level

    Time frame: Baseline, 3 months, and 6 months after treatment

    Assessment of changes in clinical attachment level (CAL) after periodontal treatment.

  2. Bleeding on Probing

    Time frame: Baseline, 3 months, and 6 months after treatment

    Assessment of bleeding on probing (BOP) in residual periodontal pockets following treatment.

  3. BANA Test Results

    Time frame: Baseline, 3 months, and 6 months after treatment

    Microbiological evaluation of red complex periodontal pathogens using the benzoyl-DL-arginine naphthylamide (BANA) assay.

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

Clinical and Microbiological Effects of Adjunctive Ozone Application During Repeated Scaling and Root Planing for Residual Periodontal Pockets in Periodontal Maintenance Patients: A 6-Month Randomized Controlled Clinical Trial

Acronym: OZPOCKET

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
May 22, 2026
Registry last updated
May 22, 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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