Effects of Ozone Therapy as an Adjunct to Periodontal Treatment

Study Overview
=================
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.

Official Title
-----------------
The Effects of Ozone Therapy as an Adjunct to Periodontal Treatment: A Randomized Split-Mouth Clinical Trial

Conditions
-----------------
Periodontitis

Intervention / Treatment
-----------------
* Device: Ozone application with the Ozonytron XL device


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: In this study the investigators select the split mouth study design to eleminate host effects on healing.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ozone group<br>topical gaseous ozone was applied into periodontal pockets during active periodontal therapy | Device: Ozone application with the Ozonytron XL device<br>* 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<br>|
| No Intervention: non-ozone group<br>Only active periodontal therapy was performed | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periodontal disease parameters change | Probing depth (mm) were evaluated by periodontal probe. | Examinations were performed at baseline and 3 months after periodontal therapy. Changes is determined with baseline values - 3 months after periodontal treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gingival crevicular inflammatory parameter change | Gingival crevicular fluid pentraxin-3 (PTX-3) ng/mL was evaluated. | 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. |