PeriodontitisOFD-OZONENCT07551297
Ozone Therapy After Open Flap Debridement in Periodontitis
A study testing Open Flap Debridement and Ozone Therapy in people with Periodontitis and Stage III Periodontitis, run by Alparslan Dilsiz at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Periodontitis, Stage III Periodontitis
- What is being tested?
- Open Flap Debridement and Ozone Therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 18 Feb 2026
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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: 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
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Periodontitis, Stage III Periodontitis
- Being tested
- Open Flap Debridement, Ozone Therapy
- Keywords
- Ozone Therapy, Open Flap Debridement, Periodontal Surgery, Split-Mouth Study, Clinical Attachment Level, Probing Pocket Depth, Periodontal Treatment, Adjunctive Therapy
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Flap DebridementProcedure or surgery
Open flap debridement was performed to gain access to root surfaces for removal of subgingival plaque and calculus in sites with periodontal pockets.
Ozone TherapyDevice
Adjunctive ozone therapy was applied to the test sites following open flap debridement using an ozone delivery device according to the manufacturer's instructions.
| Study group | Role | What they receive |
|---|---|---|
| Ozone Group | Experimental | Sites treated with open flap debridement combined with adjunctive ozone therapy. Receives: Procedure: Open Flap Debridement; Device: Ozone Therapy |
| Control Group | Active comparator | Sites treated with open flap debridement alone without adjunctive ozone therapy. Receives: Procedure: Open Flap Debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Probing Pocket Depth (PPD)
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.
Measured: Baseline to 12 months
Secondary outcomes (4)
Change in Clinical Attachment Level (CAL)
Clinical attachment level (CAL) will be measured in millimeters at baseline and 12 months to assess changes in periodontal attachment.
Measured: Baseline to 12 months
Change in Bleeding on Probing (BOP)
Bleeding on probing (BOP) will be recorded as the presence or absence of bleeding following probing at baseline and 12 months.
Measured: Baseline to 12 months
Change in Gingival Index (GI)
Gingival index (GI) will be assessed to evaluate gingival inflammation at baseline and 12 months.
Measured: Baseline to 12 months
Change in Plaque Index (PI)
Plaque index (PI) will be recorded to assess oral hygiene status at baseline and 12 months.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start1 Jan 2025
- Primary completion25 Jan 2026
- Study completion18 Feb 2026
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.
- 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
- Parallel groups
- Model description
- This study was designed as a randomized split-mouth clinical trial. In each participant, contralateral sites were randomly assigned to either the test group (open flap debridement with adjunctive ozone therapy) or the control group (open flap debridement alone).
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alparslan Dilsiz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alparslan Dilsiz, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07551297
- Sponsor's protocol ID
- ATAUNI-PERIO-OFD-OZONE-2026
- Acronym
- OFD-OZONE
- Status last verified
- Apr 2026
- First submitted
- 18 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to institutional policies and privacy considerations.
Publications
Mangal S, Kaushal S, Lal N, Pathak AK, Agarwal B, Shukla S. Comparison of ozone therapy and antimicrobial photodynamic therapy in periodontitis: A randomized clinical trial. J Oral Biol Craniofac Res. 2026 Mar-Apr;16(2):101393. doi: 10.1016/j.jobcr.2025.12.011. Epub 2026 Jan 13.
PubMed 41584216
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07551297
- Acronym / sponsor ID
- OFD-OZONE / ATAUNI-PERIO-OFD-OZONE-2026
- Conditions
- Periodontitis, Stage III Periodontitis
- Keywords
- Ozone Therapy, Open Flap Debridement, Periodontal Surgery, Split-Mouth Study, Clinical Attachment Level, Probing Pocket Depth, Periodontal Treatment, Adjunctive Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Alparslan DilsizUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 25 Jan 2026 (actual)
- Study completion
- 18 Feb 2026 (actual)
- First posted
- 24 Apr 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study was designed as a randomized split-mouth clinical trial. In each participant, contralateral sites were randomly assigned to either the test group (open flap debridement with adjunctive ozone therapy) or the control group (open flap debridement alone).
| Arm | Type | Receives |
|---|---|---|
| Ozone Group | Experimental | Procedure: Open Flap Debridement, Device: Ozone TherapySites treated with open flap debridement combined with adjunctive ozone therapy. |
| Control Group | Active comparator | Procedure: Open Flap DebridementSites treated with open flap debridement alone without adjunctive ozone therapy. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Open Flap DebridementOpen flap debridement was performed to gain access to root surfaces for removal of subgingival plaque and calculus in sites with periodontal pockets. | Procedure or surgery | Control Group, Ozone Group |
| Ozone TherapyAdjunctive ozone therapy was applied to the test sites following open flap debridement using an ozone delivery device according to the manufacturer's instructions. | Device | Ozone Group |
Primary outcome
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.
4 secondary outcomes
Change in Clinical Attachment Level (CAL)
Time frame: Baseline to 12 months
Change in Bleeding on Probing (BOP)
Time frame: Baseline to 12 months
Change in Gingival Index (GI)
Time frame: Baseline to 12 months
Change in Plaque Index (PI)
Time frame: Baseline to 12 months
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 24 Apr 2026.
- Background: PubMed 41584216Mangal S, Kaushal S, Lal N, Pathak AK, Agarwal B, Shukla S. Comparison of ozone therapy and antimicrobial photodynamic therapy in periodontitis: A randomized clinical trial. J Oral Biol Craniofac Res. 2026 Mar-Apr;16(2):101393. doi: 10.1016/j.jobcr.2025.12.011. Epub 2026 Jan 13.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to institutional policies and privacy 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 Open Flap Debridement and Ozone Therapy in people with Periodontitis and Stage III Periodontitis, run by Alparslan Dilsiz 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 7 inclusion and 6 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 24 Apr 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 Pocket Depth (PPD) (time frame: Baseline to 12 months). 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 NCT07551297, 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 24 Apr 2026.