Impact of Ozone Application in Periodontitis Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Probing pocket depth
Study Overview
Brief 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. 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •Participants will be excluded if they had less than 20 teeth, partial dentures, or fixed prosthodontics.
Arms & Interventions
ozone
Gaseous ozone was applied immediately after non-surgical periodontal treatment
Intervention: Non-surgical periodontal treatment (Procedure)
control
Only non-surgical periodontal treatment was applied
Intervention: Non-surgical periodontal treatment (Procedure)
ozone
Gaseous ozone was applied immediately after non-surgical periodontal treatment
Intervention: Ozone therapy using a device (Ozone DTA Ozone Generator, Denta Tec Dental AS, Norway) (Device)
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Plaque index (Silness & Löe, 1964)(3rd month)
- Gingival Index ( Löe & Silness,1963)(3rd month)
- Bleeding on probing(3rd month)
- Inflammatory parameter levels in gingival crevicular fluid(3rd month)
- Proportions of bacterial species(3rd month)
- Plaque index (Silness & Löe, 1964)(Baseline (prior to therapy))
- Gingival Index ( Löe & Silness,1963)(Baseline (prior to therapy))
- Bleeding on probing(Baseline (prior to therapy))
- Proportions of bacterial species(Baseline (prior to therapy))
- Proportions of bacterial species(1st month)
- Inflammatory parameter levels in gingival crevicular fluid(Baseline (prior to therapy))
- Inflammatory parameter levels in gingival crevicular fluid(1st month)
Investigators
Burcu KARADUMAN
Principle Investigator
Biruni University