Use of the Ozone in Periodontal Treatment

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the clinicaland laboratory (as oxidative stress and pro-inflammatory mediators) effects of the use of gaseous ozone in periodontal treatment in addition to scaling and root planning. The study population consisted of 40 patients with CP (chronic periodontitis). It was performed with two groups; The Test Group, and the Control Group. SRP plus gaseous ozone [1 W (100 mJ, 10 Hz)] was applied to the Test Group. The Control Group, on the other hand, had only SRP.The clinical periodontal parameters were performed and saliva samples were taken before SRP (baseline) and 1 month after treatment. The periodontal examination involved assessing the plaque index, gingival index , probing depth, and clinical attachment level. The total antioxidant status, total oxidant status, nitric oxide, 8-hidroxi-deoksiguanosine, myeloperoxidase, glutathione, malondialdehyde and transforming growth factor-beta levels were determined in the saliva samples.

Detailed Description
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The study has been designed in a randomized parallelly-controlled and double-blinded design as a full-mouth clinical trial. The duration of the study was 1 month. The study was performed with two groups; The Test Group, and the Control Group. SRP plus gaseous ozone [1 W (100 mJ, 10 Hz), (n=20)] was applied to the Test Group. The Control Group, on the other hand, had SRP plus placebo (n=20). The patients were distributed in random order to the 2 groups (each group had 20 patients). One patient in the Ozone Group and 2 patients in the Control Group left the study. The following clinical periodontal parameters were performed immediately before SRP (baseline), and 1 month after treatment for each test and control groups. Plaque index, GI, PD and CAL were recorded. All clinical parameter measurements were used a manual periodontal probe (PCP- 12, Hu-Friedy, Chicago, IL, USA). The total antioxidant status, total oxidant status, nitric oxide, 8-hidroxi-deoksiguanosine, myeloperoxidase, glutathione, malondialdehyde and transforming growth factor-beta levels were determined in the saliva samples.

Official Title
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Evaluating the Clinical and Laboratory Effects of the Use of Ozone in nonsurgıcal perıodontal Treatment : a Randomized Controlled Trial

Conditions
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Chronic Periodontitis

Intervention / Treatment
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* Device: Gaseous ozone
* Device: SRP plus placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients having had generalize CP which were agreed upon by consensus at the World Workshop in Periodontics in 1999 [24]; three or more teeth having at least two quadrants with probing depth between 4 and 6 mm and radiographic signs of bone loss; aged 30 years and above; a minimum of 20 teeth. Exclusion Criteria: received periodontal therapy within the last 12 months; systemic diseases which could affect periodontal treatment outcomes; having taken systemic antibiotics within the last 6 months; pregnancy or breast-feeding for female patients.

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: RANDOMIZED CONTROLLED TRIAL
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>SRP plus placebo | Device: SRP plus placebo<br>* only SRP<br>|
| Experimental: Gaseous ozone group<br>SRP plus gaseous ozone [1 W (100 mJ, 10 Hz)] | Device: Gaseous ozone<br>* SRP plus gaseous ozone<br>* Other names: Ozone DTA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laboratory findings | The total antioxidant status levels ( mmol/L) were determined in the saliva samples. | One month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical findings | Probing depth was measured the distance between the gingival margin and the deepest aspect of the pocket (mm). | One month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Periodontal treatment, Ozone, oxidative stress