Clinical trial NCT05971706: Ozone Application in Periodontal Treatment
Official title: Impact of Ozone Application in Periodontitis Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Periodontitis
Keywords: periodontitis
ozone
treatment
Lead sponsor: Biruni University
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Probing pocket depth
timeFrame: Baseline (prior to therapy)
measure: Probing pocket depth
timeFrame: 3rd month after treatment
Secondary outcomes:
measure: Plaque index (Silness & Löe, 1964)
timeFrame: Baseline (prior to therapy)
measure: Plaque index (Silness & Löe, 1964)
timeFrame: 3rd month
measure: Gingival Index ( Löe & Silness,1963)
timeFrame: Baseline (prior to therapy)
measure: Gingival Index ( Löe & Silness,1963)
timeFrame: 3rd month
measure: Bleeding on probing
timeFrame: Baseline (prior to therapy)
measure: Bleeding on probing
timeFrame: 3rd month
measure: Proportions of bacterial species
timeFrame: Baseline (prior to therapy)
measure: Proportions of bacterial species
timeFrame: 1st month
measure: Proportions of bacterial species
timeFrame: 3rd month
measure: Inflammatory parameter levels in gingival crevicular fluid
timeFrame: Baseline (prior to therapy)
measure: Inflammatory parameter levels in gingival crevicular fluid
timeFrame: 1st month
measure: Inflammatory parameter levels in gingival crevicular fluid
timeFrame: 3rd month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Biruni University
Study officials:
References: