Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
18 participants
INTERVENTIONAL
2023-09-27
2025-11-15
Brief Summary
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• 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
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ozone
Gaseous ozone was applied immediately after non-surgical periodontal treatment
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.
Non-surgical periodontal treatment
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.
control
Only non-surgical periodontal treatment was applied
Non-surgical periodontal treatment
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.
Interventions
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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.
Non-surgical periodontal treatment
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
18 Years
65 Years
ALL
Yes
Sponsors
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Biruni University
OTHER
Responsible Party
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Burcu KARADUMAN
Principle Investigator
Locations
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Biruni University
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Burcu Karaduman
Role: primary
Other Identifiers
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Ozone
Identifier Type: -
Identifier Source: org_study_id