- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07604636
Adjunctive Ozone Therapy for Residual Periodontal Pockets (OZPOCKET)
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Erzurum, Turkey (Türkiye)
- Ataturk University Faculty of Dentistry, Department of Periodontology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Repeated Scaling and Root Planing
Residual periodontal pockets received repeated scaling and root planing alone following periodontal maintenance therapy.
|
Repeated scaling and root planing of residual periodontal pockets was performed using mini-curettes under local anesthesia following periodontal maintenance therapy.
Other Names:
|
|
Experimental: Repeated Scaling and Root Planing Plus Ozone
Residual periodontal pockets received repeated scaling and root planing combined with gaseous ozone application following periodontal maintenance therapy.
|
Repeated scaling and root planing of residual periodontal pockets was performed using mini-curettes under local anesthesia following periodontal maintenance therapy.
Other Names:
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline, 3 months, and 6 months after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline, 3 months, and 6 months after treatment
|
|
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.
|
Baseline, 3 months, and 6 months after treatment
|
|
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.
|
Baseline, 3 months, and 6 months after treatment
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Periodontal Diseases
- Mouth Diseases
- Stomatognathic Diseases
- Periodontitis
- Periodontal Pocket
- Digestive System and Oral Physiological Phenomena
- Dentistry
- Dental Physiological Phenomena
- Dental Scaling
- Dental Prophylaxis
- Periodontics
- Subgingival Curettage
- Preventive Dentistry
- Root Planing
- Tooth Exfoliation
Other Study ID Numbers
- ATAUNI-OZONEPOCKET-26
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Periodontitis
-
Mahsa UniversityRecruitingPeriodontitis | Periodontitis Chronic Generalized Moderate | Periodontitis (Stage 3) | Periodontitis, Adult | Periodontitis Chronic Generalized Severe | Periodontitis, Chronic | Periodontitis Stage II | Periodontitis Chronic Localized Slight | Periodontitis Stage IIIMalaysia
-
Shanghai Ninth People's Hospital Affiliated to...Not yet recruitingPeriodontitis Stage II | Periodontitis Stage III | Periodontitis Stage IV
-
Misr University for Science and TechnologyCompletedPeriodontitis | Periodontitis Stage I | Periodontitis Stage II | Periodontitis Stage IIIEgypt
-
Cairo UniversityRecruitingPeriodontitis | Periodontitis Stage II | Periodontitis Stage IIIEgypt
-
Ataturk UniversityCompletedPeriodontitis | Periodontitis Stage I | Periodontitis Stage IITurkey (Türkiye)
-
Al-Azhar UniversityNot yet recruitingStage IV Periodontitis | Advanced Periodontitis | Stage III PeriodontitisEgypt
-
Panineeya Mahavidyalaya Institute of Dental Sciences...Research Institute for Genetic and Human TherapyUnknownGeneralized Adult Periodontitis
-
Duygu DegirmenciogluNot yet recruitingApical PeriodontitisTurkey (Türkiye)
-
University of ZagrebActive, not recruitingApical PeriodontitisCroatia
-
Azienda Socio Sanitaria Territoriale degli Spedali...Università degli Studi di FerraraCompletedPeriodontitis, Aggressive | Periodontitis, AdultItaly
Clinical Trials on Scaling and Root Planing
-
University of NebraskaCompletedPeriodontal Diseases | Periodontitis, Apical, Chronic Nonsuppurative | Suppuration of Gingival CreviceUnited States
-
University of CataniaCompletedPeriodontal DiseasesItaly
-
Institut Straumann AGCompleted
-
Mohammed Bin Rashid University of Medicine and...RecruitingPeriodontal DiseasesUnited Arab Emirates
-
University of BaghdadNot yet recruiting
-
Kutahya Health Sciences UniversityCompletedPeriodontitis | Gingivitis | Dental Anxiety | Dental Fear | Calculus, DentalTurkey
-
University of MessinaCompleted
-
University of MichiganCompletedPeriodontal Diseases | Dental DiseasesUnited States
-
Dr.K.Sai PriyankaPanineeya Mahavidyalaya Institute of Dental Sciences & Research CentreCompletedGingivitis and Periodontal Diseases
-
Panineeya Mahavidyalaya Institute of Dental Sciences...CompletedChronic Periodontitis | Renal Insufficiency Chronic