Periodontitis
Conditions
Brief summary
This randomized, placebo controlled, split-mouth clinical study trial evaluates the effects of Ozone therapy on clinical and biochemical parameters. Total of 20 participants completed the study . Periodontal parameters were evaluated at baseline and 3 months following periodontal therapy. All participants were treated non-surgically. Topical gaseous ozone was applied into periodontal pockets. Gingival crevicular fluid pentraxin-3 (PTX-3), interleukin-1β (IL-1β) and high sensitivity C-reactive protein (Hs-CRP) were evaluated.
Detailed description
Ozone therapy (OT) is very popular in medicine. Especially it use for wound healing and antibacterial properties. This randomized, placebo controlled, randomized split-mouth clinical study evaluates the effects of ozone therapy on clinical and biochemical parameters. Total of 20 participants completed the study (10 males, 10 females). Periodontal parameters, including plaque index (PI), gingival index (GI), probing depth (PD), percentage of bleeding on probing, percentage of pockets deeper than 5 mm and clinical attachment level (CAL), and percentage of ≥3 mm clinical attachment level. Periodontal parameters were evaluated at baseline and 3 months following periodontal therapy. All participants were treated non-surgically. Topical gaseous ozone was applied into periodontal pockets twice a week for 2 weeks during active periodontal therapy. Gingival crevicular fluid pentraxin-3 (PTX-3), interleukin-1β (IL-1β) and high sensitivity C-reactive protein (Hs-CRP) were evaluated.
Interventions
DEVICEOzone application with the Ozonytron XL device
An ozone generator (Ozonytron; Bionix, Munchen, Germany) with an KPX probe (CA Probe; Ozonytron, Bionix, Munchen, Germany) was used for OT. Topical gaseous ozone was applied into the periodontal pocket twice a week for 2 weeks based on the manufacturer's instructions. Ozone applications were at 75% power for 30 seconds (75 µg/ml). Ozone applications were performed by an experienced investigator. Ozone applications in the control side were simulated without starting the ozone generator
Sponsors
TC Erciyes University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Investigators who evaluate the clinical and biochemical parameters did no know the groups. And participants did not know ozone device work or not when holding the probe.
Intervention model description
In this study the investigators select the split mouth study design to eleminate host effects on healing.
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* 18 to 64 years of age * Generalized chronic periodontitis(Armitage, 1999) * Systemically healthy * More than 20 teeth (excluding third molars)
Exclusion criteria
* Periodontal treatment within 6 months * Antibiotic use within the previous 3 months * Pregnancy and lactation * Past or current smoking and alcohol consumption * Contraindications for OT * Patients with class II and III furcation defects(Staffileno, 1969)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Periodontal disease parameters change | Examinations were performed at baseline and 3 months after periodontal therapy. Changes is determined with baseline values - 3 months after periodontal treatment. | Probing depth (mm) were evaluated by periodontal probe. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gingival crevicular inflammatory parameter change | inflammatory biochemical parameters were analyzed at baseline and 3 months after periodontal therapy and changes is determined with baseline values - 3 months after periodontal therapy. | Gingival crevicular fluid pentraxin-3 (PTX-3) ng/mL was evaluated. |
Outcome results
None listed