PeriodontitisOZPOCKETNCT07604636
Adjunctive Ozone Therapy for Residual Periodontal Pockets
A study testing Scaling and Root Planing and Gaseous Ozone Application in people with Periodontitis and Residual Periodontal Pocket, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis, Residual Periodontal Pocket, Periodontal Pocket
- What is being tested?
- Scaling and Root Planing and Gaseous Ozone Application
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2024to 20 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Furcation involvement
- Tooth mobility ≥ degree 1
- Restorations on selected teeth
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ataturk University Faculty of Dentistry, Department of Periodontology
Erzurum
About this study
Official 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
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.
Read the 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.
- Conditions
- Periodontitis, Residual Periodontal Pocket, Periodontal Pocket, Stage III Periodontitis, Stage IV Periodontitis
- Being tested
- Scaling and Root Planing, Gaseous Ozone Application
- Keywords
- Ozone Therapy, Scaling and Root Planing, Periodontal Maintenance, Residual Pocket, Pocket Closure, Periodontal Debridement, BANA Test, Periodontal Pathogens
- Medical subject headings
- Periodontitis, Periodontal Pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scaling and Root PlaningProcedure or surgery
Also called Subgingival Reinstrumentation
Repeated scaling and root planing of residual periodontal pockets was performed using mini-curettes under local anesthesia following periodontal maintenance therapy.
Gaseous Ozone ApplicationDevice
Also called Ozone Therapy
Gaseous ozone was applied into residual periodontal pockets using the OzoneDTA device with a periodontal probe tip according to the manufacturer's instructions.
| Study group | Role | What they receive |
|---|---|---|
| Repeated Scaling and Root Planing | Active comparator | Residual periodontal pockets received repeated scaling and root planing alone following periodontal maintenance therapy. Receives: Procedure: Scaling and Root Planing |
| Repeated Scaling and Root Planing Plus Ozone | Experimental | Residual periodontal pockets received repeated scaling and root planing combined with gaseous ozone application following periodontal maintenance therapy. Receives: Procedure: Scaling and Root Planing; Device: Gaseous Ozone Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Probing Depth
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.
Measured: Baseline, 3 months, and 6 months after treatment
Secondary outcomes (3)
Change in Clinical Attachment Level
Assessment of changes in clinical attachment level (CAL) after periodontal treatment.
Measured: Baseline, 3 months, and 6 months after treatment
Bleeding on Probing
Assessment of bleeding on probing (BOP) in residual periodontal pockets following treatment.
Measured: Baseline, 3 months, and 6 months after treatment
BANA Test Results
Microbiological evaluation of red complex periodontal pathogens using the benzoyl-DL-arginine naphthylamide (BANA) assay.
Measured: Baseline, 3 months, and 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start15 Mar 2024
- Primary completion15 Dec 2024
- Study completion20 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study was designed as a split-mouth randomized controlled clinical trial in which residual periodontal pockets within the same participant were randomly assigned to either repeated scaling and root planing alone or repeated scaling and root planing combined with gaseous ozone application.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alparslan Dilsiz, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07604636
- Sponsor's protocol ID
- ATAUNI-OZONEPOCKET-26
- Acronym
- OZPOCKET
- Status last verified
- May 2026
- First submitted
- 17 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly available due to privacy and confidentiality considerations.
Publications
Sanz M, Herrera D, Kebschull M, Chapple I, Jepsen S, Beglundh T, Sculean A, Tonetti MS; EFP Workshop Participants and Methodological Consultants. Treatment of stage I-III periodontitis-The EFP S3 level clinical practice guideline. J Clin Periodontol. 2020 Jul;47 Suppl 22(Suppl 22):4-60. doi: 10.1111/jcpe.13290.
PubMed 32383274
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07604636
- Acronym / sponsor ID
- OZPOCKET / ATAUNI-OZONEPOCKET-26
- Conditions
- Periodontitis, Residual Periodontal Pocket, Periodontal Pocket, Stage III Periodontitis, Stage IV Periodontitis
- Keywords
- Ozone Therapy, Scaling and Root Planing, Periodontal Maintenance, Residual Pocket, Pocket Closure, Periodontal Debridement, BANA Test, Periodontal Pathogens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study was designed as a split-mouth randomized controlled clinical trial in which residual periodontal pockets within the same participant were randomly assigned to either repeated scaling and root planing alone or repeated scaling and root planing combined with gaseous ozone application.
| Arm | Type | Receives |
|---|---|---|
| Repeated Scaling and Root Planing | Active comparator | Procedure: Scaling and Root PlaningResidual periodontal pockets received repeated scaling and root planing alone following periodontal maintenance therapy. |
| Repeated Scaling and Root Planing Plus Ozone | Experimental | Procedure: Scaling and Root Planing, Device: Gaseous Ozone ApplicationResidual periodontal pockets received repeated scaling and root planing combined with gaseous ozone application following periodontal maintenance therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scaling and Root PlaningAlso: Subgingival ReinstrumentationRepeated scaling and root planing of residual periodontal pockets was performed using mini-curettes under local anesthesia following periodontal maintenance therapy. | Procedure or surgery | Repeated Scaling and Root Planing, Repeated Scaling and Root Planing Plus Ozone |
| Gaseous Ozone ApplicationAlso: Ozone TherapyGaseous ozone was applied into residual periodontal pockets using the OzoneDTA device with a periodontal probe tip according to the manufacturer's instructions. | Device | Repeated Scaling and Root Planing Plus Ozone |
Primary outcome
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.
3 secondary outcomes
Change in Clinical Attachment Level
Time frame: Baseline, 3 months, and 6 months after treatment
Bleeding on Probing
Time frame: Baseline, 3 months, and 6 months after treatment
BANA Test Results
Time frame: Baseline, 3 months, and 6 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Results publication: PubMed 32383274Sanz M, Herrera D, Kebschull M, Chapple I, Jepsen S, Beglundh T, Sculean A, Tonetti MS; EFP Workshop Participants and Methodological Consultants. Treatment of stage I-III periodontitis-The EFP S3 level clinical practice guideline. J Clin Periodontol. 2020 Jul;47 Suppl 22(Suppl 22):4-60. doi: 10.1111/jcpe.13290.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly available due to privacy and confidentiality considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scaling and Root Planing and Gaseous Ozone Application in people with Periodontitis and Residual Periodontal Pocket, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Probing Depth (time frame: Baseline, 3 months, and 6 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07604636, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.