PeriodontitisNCT05971706
Ozone Application in Periodontal Treatment
A study testing Ozone therapy using a device (Ozone DTA Ozone Generator, Denta Tec Dental AS, Norway) and Non-surgical periodontal treatment in people with Periodontitis, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
This clinical trial aims to evaluate the clinical, biochemical and microbiological efficacy of ozone treatment as an adjunct to nonsurgical periodontal treatment (NSPT) in periodontitis patients. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Ozone therapy using a device (Ozone DTA Ozone Generator, Denta Tec Dental AS, Norway) and Non-surgical periodontal treatment
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Oct 2023to 1 Oct 2024
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- systemically healthy
- no periodontal treatment within 6 months from the enrollment date
- no antibiotics or anti-inflammatory medication taken within 6 months from the enrollment date
- no smokers
- no pregnancy or lactation at the time of the stud
- no contraindication for periodontal treatment and ozone application
Who cannot join
- Participants will be excluded if they had less than 20 teeth, partial dentures, or fixed prosthodontics.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Ozone Application in Periodontitis Patients
This clinical trial aims to evaluate the clinical, biochemical and microbiological efficacy of ozone treatment as an adjunct to nonsurgical periodontal treatment (NSPT) in periodontitis patients. The main question it aims to answer is:
- Is the application of gaseous ozone, as an adjunct to NSPT, to periodontal pockets in patients with periodontitis alters the clinical periodontal parameters, gingival crevicular fluid levels of inflammatory cytokines, and periodontal pathogens compared to NSPT alone? The study will be performed according to a split-mouth design, the contralateral quadrants with similar periodontal status in each patient will be randomly allocated to one of the following two different treatment modalities.
Read more
Participants will be applied NSPT consisting of supra and subgingival debridement.
- NSPT will be applied alone in one quadrant
- In addition to NSPT, ozone therapy procedures were performed using a device at contralateral sites.
Researchers will compare the sites with and without ozone therapy in addition to NSPT to see if ozone therapy adjunct to the NSPT affects clinical, biochemical, and microbiological changes
- Conditions
- Periodontitis
- Being tested
- Ozone therapy using a device (Ozone DTA Ozone Generator, Denta Tec Dental AS, Norway), Non-surgical periodontal treatment
- Keywords
- periodontitis, ozone, treatment
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ozone therapy using a device (Ozone DTA Ozone Generator, Denta Tec Dental AS, Norway)Device
Ozone therapy procedures will be performed immediately after non-surgical periodontal treatment and three times (every third day) within one week using a device equipped with a periodontal tip according to equipment producer recommendations. The periodontal tip will be halted 1 mm short of the pocket depth. Ozone will be applied only to the pockets; which depth is equal to or greater than 5 mm. Ozone application time to the pockets will be 30 seconds at a fixed concentration of 2,100 ppm (80% oxygen) through a connected handpiece.
Non-surgical periodontal treatmentProcedure or surgery
Non-surgical periodontal treatment consists of oral hygiene instructions, full mouth supragingival scaling using hand instruments, ultrasonic devices, polishing, and subgingival debridement under local anesthesia with sharp Gracey and Universal curettes and ultrasonic instruments in a single appointment.
| Study group | Role | What they receive |
|---|---|---|
| ozone | Experimental | Gaseous ozone was applied immediately after non-surgical periodontal treatment Receives: Device: Ozone therapy using a device (Ozone DTA Ozone Generator, Denta Tec Dental AS, Norway); Procedure: Non-surgical periodontal treatment |
| control | Active comparator | Only non-surgical periodontal treatment was applied Receives: Procedure: Non-surgical periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing pocket depth
Probing pocket depth: The distance from the base of the pocket to the gingival margin. Measurements will be made at six points on all teeth (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) using a periodontal probe.
Measured: Baseline (prior to therapy)
Probing pocket depth
robing pocket depth: The distance from the base of the pocket to the gingival margin. Measurements will be made at six points on all teeth (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) using a periodontal probe.
Measured: 3rd month after treatment
Secondary outcomes (12)
Plaque index (Silness & Löe, 1964)
Plaque index (Silness \& Löe, 1964):
0: Absence of microbial plaque
- Thin plaque layer at the gingival margin, only detectable by scraping with a probe
- Moderate layer of plaque in the along the gingival margin; interdental spaces free, but plaque is visible to naked eye
- Abundant plaque along with the gingival margin; interdental places filled with plaque
Measured: Baseline (prior to therapy)
Plaque index (Silness & Löe, 1964)
Plaque index (Silness \& Löe, 1964):
0: Absence of microbial plaque
- Thin plaque layer at the gingival margin, only detectable by scraping with a probe
- Moderate layer of plaque in the along the gingival margin; interdental spaces free, but plaque is visible to naked eye
- Abundant plaque along with the gingival margin; interdental places filled with plaque
Measured: 3rd month
Gingival Index ( Löe & Silness,1963)
0 = normal gingiva
- = mild inflammation - slight change in color and slight edema but no bleeding on probing
- = moderate inflammation - redness, edema and glazing, bleeding on probing
- = severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding
Measured: Baseline (prior to therapy)
Gingival Index ( Löe & Silness,1963)
0 = normal gingiva
- = mild inflammation - slight change in color and slight edema but no bleeding on probing
- = moderate inflammation - redness, edema and glazing, bleeding on probing
- = severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding
Measured: 3rd month
Bleeding on probing
A bleeding-on-probing percentage score assessed as the proportion of bleeding sites (dichotomous yes/no evaluation) when stimulated by a standardized manual probe with a controlled (~25 g) force to the bottom of the sulcus/pocket at six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) on all present teeth (Ainamo \& Bay 1975).
Measured: Baseline (prior to therapy)
Bleeding on probing
A bleeding-on-probing percentage score assessed as the proportion of bleeding sites (dichotomous yes/no evaluation) when stimulated by a standardized manual probe with a controlled (~25 g) force to the bottom of the sulcus/pocket at six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) on all present teeth (Ainamo \& Bay 1975).
Measured: 3rd month
Proportions of bacterial species
Subgingival plaque sampling will be performed at the 3 deepest pockets with a probing depth equal to or higher than 5mm in each treatment site with no endodontic or furcation involvement using 2 standardized sterile paper points. One will be inserted at a 45-degree angle and the other will be inserted parallel to the tooth axis and left in place for 30 seconds. Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Tannerella forsythia will be evaluated.
Measured: Baseline (prior to therapy)
Proportions of bacterial species
Subgingival plaque sampling will be performed at the 3 deepest pockets with a probing depth equal to or higher than 5mm in each treatment site with no endodontic or furcation involvement using 2 standardized sterile paper points. One will be inserted at a 45-degree angle and the other will be inserted parallel to the tooth axis and left in place for 30 seconds. Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Tannerella forsythia will be evaluated.
Measured: 1st month
Proportions of bacterial species
Subgingival plaque sampling will be performed at the 3 deepest pockets with a probing depth equal to or higher than 5mm in each treatment site with no endodontic or furcation involvement using 2 standardized sterile paper points. One will be inserted at a 45-degree angle and the other will be inserted parallel to the tooth axis and left in place for 30 seconds. Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Tannerella forsythia will be evaluated.
Measured: 3rd month
Inflammatory parameter levels in gingival crevicular fluid
Subgingival plaque sampling will be performed at the 3 deepest pockets with a probing depth equal to or higher than 5mm in each treatment site with no endodontic or furcation involvement using sterile paper strips. Gingival crevicular fluid Tumor necrotizing factor-alpha, interleukin-1beta, interleukin-6, interleukin-8 levels will be evaluated.
Measured: Baseline (prior to therapy)
Inflammatory parameter levels in gingival crevicular fluid
Subgingival plaque sampling will be performed at the 3 deepest pockets with a probing depth equal to or higher than 5mm in each treatment site with no endodontic or furcation involvement using sterile paper strips. Gingival crevicular fluid Tumor necrotizing factor-alpha, interleukin-1beta, interleukin-6, interleukin-8 levels will be evaluated.
Measured: 1st month
Inflammatory parameter levels in gingival crevicular fluid
Subgingival plaque sampling will be performed at the 3 deepest pockets with a probing depth equal to or higher than 5mm in each treatment site with no endodontic or furcation involvement using sterile paper strips. Gingival crevicular fluid Tumor necrotizing factor-alpha, interleukin-1beta, interleukin-6, interleukin-8 levels will be evaluated.
Measured: 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start27 Oct 2023
- Primary completion15 Jun 2024
- Study completion1 Oct 2024
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 Biruni 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu KARADUMAN, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971706
- Sponsor's protocol ID
- Ozone
- Status last verified
- Feb 2026
- First submitted
- 25 Jul 2023
- Last updated
- 10 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cetiner DO, Karaduman B, Selman AE, Gonen S, Corekci AU. Adjunctive effect of gaseous ozone on inflammatory biomarkers and microbial profile in grade C molar-incisor pattern periodontitis: a randomized split-mouth placebo-controlled clinical trial. BMC Oral Health. 2026 Apr 6;26(1):938. doi: 10.1186/s12903-026-08213-w.
PubMed 41942979
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Ozone Application in Periodontitis Patients
- ClinicalTrials.gov ID
- NCT05971706
- Acronym / sponsor ID
- Ozone
- Conditions
- Periodontitis
- Keywords
- periodontitis, ozone, treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 27 Oct 2023 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 2 Aug 2023 (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.
This clinical trial aims to evaluate the clinical, biochemical and microbiological efficacy of ozone treatment as an adjunct to nonsurgical periodontal treatment (NSPT) in periodontitis patients. The main question it aims to answer is:
- Is the application of gaseous ozone, as an adjunct to NSPT, to periodontal pockets in patients with periodontitis alters the clinical periodontal parameters, gingival crevicular fluid levels of inflammatory cytokines, and periodontal pathogens compared to NSPT alone? The study will be performed according to a split-mouth design, the contralateral quadrants with similar periodontal status in each patient will be randomly allocated to one of the following two different treatment modalities.
Participants will be applied NSPT consisting of supra and subgingival debridement.
- NSPT will be applied alone in one quadrant
- In addition to NSPT, ozone therapy procedures were performed using a device at contralateral sites.
Researchers will compare the sites with and without ozone therapy in addition to NSPT to see if ozone therapy adjunct to the NSPT affects clinical, biochemical, and microbiological changes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ozone | Experimental | Device: Ozone therapy using a device (Ozone DTA Ozone Generator, Denta Tec Dental AS, Norway), Procedure: Non-surgical periodontal treatmentGaseous ozone was applied immediately after non-surgical periodontal treatment |
| control | Active comparator | Procedure: Non-surgical periodontal treatmentOnly non-surgical periodontal treatment was applied |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- systemically healthy
- no periodontal treatment within 6 months from the enrollment date
- no antibiotics or anti-inflammatory medication taken within 6 months from the enrollment date
- no smokers
- no pregnancy or lactation at the time of the stud
Key exclusion criteria (1 listed)
- Participants will be excluded if they had less than 20 teeth, partial dentures, or fixed prosthodontics.
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 |
|---|---|---|
| Ozone therapy using a device (Ozone DTA Ozone Generator, Denta Tec Dental AS, Norway)Ozone therapy procedures will be performed immediately after non-surgical periodontal treatment and three times (every third day) within one week using a device equipped with a periodontal tip according to equipment producer recommendations. The periodontal tip will be halted 1 mm short of the pocket depth. Ozone will be applied only to the pockets; which depth is equal to or greater than 5 mm. Ozone application time to the pockets will be 30 seconds at a fixed concentration of 2,100 ppm (80% oxygen) through a connected handpiece. | Device | ozone |
| Non-surgical periodontal treatmentNon-surgical periodontal treatment consists of oral hygiene instructions, full mouth supragingival scaling using hand instruments, ultrasonic devices, polishing, and subgingival debridement under local anesthesia with sharp Gracey and Universal curettes and ultrasonic instruments in a single appointment. | Procedure or surgery | control, ozone |
Primary outcome
Probing pocket depth
Time frame: Baseline (prior to therapy)
Probing pocket depth: The distance from the base of the pocket to the gingival margin. Measurements will be made at six points on all teeth (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) using a periodontal probe.
Probing pocket depth
Time frame: 3rd month after treatment
robing pocket depth: The distance from the base of the pocket to the gingival margin. Measurements will be made at six points on all teeth (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) using a periodontal probe.
12 secondary outcomes
Plaque index (Silness & Löe, 1964)
Time frame: Baseline (prior to therapy)
Plaque index (Silness & Löe, 1964)
Time frame: 3rd month
Gingival Index ( Löe & Silness,1963)
Time frame: Baseline (prior to therapy)
Gingival Index ( Löe & Silness,1963)
Time frame: 3rd month
Bleeding on probing
Time frame: Baseline (prior to therapy)
Bleeding on probing
Time frame: 3rd month
Proportions of bacterial species
Time frame: Baseline (prior to therapy)
Proportions of bacterial species
Time frame: 1st month
Proportions of bacterial species
Time frame: 3rd month
Inflammatory parameter levels in gingival crevicular fluid
Time frame: Baseline (prior to therapy)
Inflammatory parameter levels in gingival crevicular fluid
Time frame: 1st month
Inflammatory parameter levels in gingival crevicular fluid
Time frame: 3rd month
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 10 Feb 2026.
- Derived from this study: PubMed 41942979Cetiner DO, Karaduman B, Selman AE, Gonen S, Corekci AU. Adjunctive effect of gaseous ozone on inflammatory biomarkers and microbial profile in grade C molar-incisor pattern periodontitis: a randomized split-mouth placebo-controlled clinical trial. BMC Oral Health. 2026 Apr 6;26(1):938. doi: 10.1186/s12903-026-08213-w.
- Individual participant dataSharing planned: No
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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 Ozone therapy using a device (Ozone DTA Ozone Generator, Denta Tec Dental AS, Norway) and Non-surgical periodontal treatment in people with Periodontitis, run by Biruni 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 6 inclusion and 1 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 10 Feb 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?
Probing pocket depth (time frame: Baseline (prior to therapy)). The study lists 2 primary outcomes in all. 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 NCT05971706, 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 10 Feb 2026.