Effects of Ozone Therapy on Clinical Parameters and Inflammatory Cytokines in Chronic Periodontitis Patients

Study Overview
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Brief Summary
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The objective of this study is to evaluate of ozone therapy on both clinical and biochemical effects in periodontally patients.

Detailed Description
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This study is evaluated clinical and biochemical effect of ozone therapy at 8 weeks in periodontitis patients.

Official Title
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Effects of Ozone Therapy Adjunct to Initial Periodontal Therapy on Clinical Parameters and Inflammatory Cytokines in Chronic Periodontitis Patients

Conditions
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Chronic Periodontitis

Intervention / Treatment
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* Other: ozone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: systemically healthy non-smokers chronic periodontitis participants Exclusion Criteria: smokers pregnancy or lactation individiuals with any systemic disease

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ozone therapy<br>control group only treated with Initial Periodontal Therapy (IPT), test group treated with IPT an adjunct to gasesos ozone therapy. | Other: ozone<br>* gaseous ozone was applied on periodontal pocket two times in one week.<br>|
| Active Comparator: initially periodontal therapy<br>control group only treated with Initial Periodontal Therapy (IPT), test group treated with IPT an adjunct to gasesos ozone therapy. | Other: ozone<br>* gaseous ozone was applied on periodontal pocket two times in one week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical atachment level baseline | Calculation as distance in millimeters from cement-enamel junction to the bottom of the pocket by Williams periodontal probe | baseline (before treatment) | 
| Plaque index baseline | As described by Silness&Löe 1964; The measurement of the state of oral hygiene by Silness-Löe plaque index is based on recording both soft debris and mineralized deposits on the following teeth. Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3. Scores 0: No plaque. scores 1: A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface. scores 2: Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye. scores 3: Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. score 0 considered good oral hygiene, score 3 bad oral hygiene habits. plaque index for a tooth=scores from 4 areas/4 plaque index individiual= scores from 28 tooth/28 | baseline (before treatment) | 
| Gingival index baseline | As described by Löe&Silness 1963; The bleeding is assessed by probing gently along the wall of soft tissue of the gingival sulcus. Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3. score 0 - Normal, healthy gingival with sharp, non-inflamed margins. score 1 - Marginal gingivitis with minimal inflammation and edema at the free gingival. No bleeding on probing. score 2 - Moderate gingivitis with a wider band of inflammation and bleeding upon probing. score 3 - Advanced gingivitis with inflammation clinically reaching the mucogingival junction usually with ulceration. score 0 considered healty gingiva, score 3 assesed advanced gingival disease. gingival index for a tooth=scores from 4 areas/4 gingival index individiual= scores from 28 tooth/28 | baseline (before treatment) | 
| Bleeding on probing baseline | As described by Ainamo&Bay 1975; The index is performed through gentle probing of the orifice of the gingival crevice. If bleeding occurs within 10 seconds a positive finding is recorded and the number of positive sites is recorded and then expressed as a percentage of the number of sites examined. bleeding present (+) absent (-) bleeding surface/all surface *100=% bleeding absent recording is equivalent to gingival index scores 0&1. bleeding present recording is equivalent to gingival index score 2&3. 0: no bleeding on probing, healty gingiva 100: all gingiva bleeding on probing; diseased gingiva. | baseline (before treatment) | 
| Probing of depth baseline | Measurement to the nearest millimeter from the gingival margin to the base of the clinical pocket by Williams periodontal probe | baseline (before treatment) | 
| Biochemical outcomes baseline | In this study, biochemical parametres including IL-1B, IL-6, IL-10, TNF-a, MMP-9 were measured (pg/ml) by ELISA (Enzyme-Linked Immuno Sorbent Assay) measured (pg/ml) by ELISA (Enzyme-Linked Immuno Sorbent Assay) methods on Gingival Crevicular Fluid at baseline. | baseline (before treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical attachment level after 8 weeks | Calculation as distance in millimeters from cement-enamel junction to the bottom of the pocket by Williams periodontal probe | 8 weeks after treatment | 
| Plaque index after 8 weeks | As described by Silness&Löe 1964; The measurement of the state of oral hygiene by Silness-Löe plaque index is based on recording both soft debris and mineralized deposits on the following teeth. Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3. Scores 0: No plaque scores 1: A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface. scores 2: Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye. scores 3: Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. score 0 considered good oral hygiene, score 3 bad oral hygiene habits. plaque index for a tooth=scores from 4 areas/4 plaque index individiual= scores from 28 tooth/28 | 8 weeks after treatment | 
| Gingival index after 8 weeks | As described by Löe&Silness 1963; The bleeding is assessed by probing gently along the wall of soft tissue of the gingival sulcus. Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3. score 0 - Normal, healthy gingival with sharp, non-inflamed margins. score 1 - Marginal gingivitis with minimal inflammation and edema at the free gingival. No bleeding on probing. score 2 - Moderate gingivitis with a wider band of inflammation and bleeding upon probing. score 3 - Advanced gingivitis with inflammation clinically reaching the mucogingival junction usually with ulceration. score 0 considered healty gingiva, score 3 assesed advanced gingival disease. gingival index for a tooth=scores from 4 areas/4 gingival index individiual= scores from 28 tooth/28 | 8 weeks after tretament | 
| Bleeding on probing after 8 weeks | As described by Ainamo&Bay 1975; the index is performed through gentle probing of the orifice of the gingival crevice. If bleeding occurs within 10 seconds a positive finding is recorded and the number of positive sites is recorded and then expressed as a percentage of the number of sites examined. bleeding present (+) absent (-) bleeding surface/all surface *100=% bleeding absent recording is equivalent to gingival index scores 0&1. bleeding present recording is equivalent to gingival index score 2&3. 0: no bleeding on probing, healty gingiva 100: all gingiva bleeding on probing; diseased gingiva. | 8 weeks after treatment | 
| Probing of dept after 8 weeks | Measurement to the nearest millimeter from the gingival margin to the base of the clinical pocket by Williams periodontal probe | 8 weeks after tretament | 
| Biochemical outcomes after 8 weeks | In this study, biochemical parametres including IL-1B, IL-6, IL-10, TNF-a, MMP-9 were measured (pg/ml) by ELISA (Enzyme-Linked Immuno Sorbent Assay) measured (pg/ml) by ELISA (Enzyme-Linked Immuno Sorbent Assay) methods on Gingival Crevicular Fluid at 8 weeks | 8 weeks after tretment |