Ataturk University Faculty of Dentistry, Department of Periodontology
Erzurum, Turkey (Türkiye)
NCT Number: NCT07604636
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Erzurum, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 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
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.
Time frame: Baseline, 3 months, and 6 months after treatment
Assessment of changes in clinical attachment level (CAL) after periodontal treatment.
Time frame: Baseline, 3 months, and 6 months after treatment
Assessment of bleeding on probing (BOP) in residual periodontal pockets following treatment.
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.
Ataturk University
Other
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
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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