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

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ozone
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • systemically healthy
  • non-smokers
  • chronic periodontitis participants

Exclusion Criteria:

  • smokers
  • pregnancy or lactation
  • individiuals with any systemic disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    ozone therapy

    initially periodontal therapy

    Arm Description

    control group only treated with Initial Periodontal Therapy (IPT), test group treated with IPT an adjunct to gasesos ozone therapy.

    control group only treated with Initial Periodontal Therapy (IPT), test group treated with IPT an adjunct to gasesos ozone therapy.

    Outcomes

    Primary Outcome Measures

    Clinical atachment level baseline
    Calculation as distance in millimeters from cement-enamel junction to the bottom of the pocket by Williams periodontal probe
    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
    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
    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.
    Probing of depth baseline
    Measurement to the nearest millimeter from the gingival margin to the base of the clinical pocket by Williams periodontal probe
    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.

    Secondary Outcome Measures

    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
    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
    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
    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.
    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
    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

    Full Information

    First Posted
    May 1, 2016
    Last Updated
    March 13, 2019
    Sponsor
    Ataturk University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03874390
    Brief Title
    Effects of Ozone Therapy on Clinical Parameters and Inflammatory Cytokines in Chronic Periodontitis Patients
    Official Title
    Effects of Ozone Therapy Adjunct to Initial Periodontal Therapy on Clinical Parameters and Inflammatory Cytokines in Chronic Periodontitis Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2014 (undefined)
    Primary Completion Date
    October 2015 (Actual)
    Study Completion Date
    February 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ataturk University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The objective of this study is to evaluate of ozone therapy on both clinical and biochemical effects in periodontally patients.
    Detailed Description
    This study is evaluated clinical and biochemical effect of ozone therapy at 8 weeks in periodontitis patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Periodontitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ozone therapy
    Arm Type
    Experimental
    Arm Description
    control group only treated with Initial Periodontal Therapy (IPT), test group treated with IPT an adjunct to gasesos ozone therapy.
    Arm Title
    initially periodontal therapy
    Arm Type
    Active Comparator
    Arm Description
    control group only treated with Initial Periodontal Therapy (IPT), test group treated with IPT an adjunct to gasesos ozone therapy.
    Intervention Type
    Other
    Intervention Name(s)
    ozone
    Intervention Description
    gaseous ozone was applied on periodontal pocket two times in one week.
    Primary Outcome Measure Information:
    Title
    Clinical atachment level baseline
    Description
    Calculation as distance in millimeters from cement-enamel junction to the bottom of the pocket by Williams periodontal probe
    Time Frame
    baseline (before treatment)
    Title
    Plaque index baseline
    Description
    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
    Time Frame
    baseline (before treatment)
    Title
    Gingival index baseline
    Description
    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
    Time Frame
    baseline (before treatment)
    Title
    Bleeding on probing baseline
    Description
    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.
    Time Frame
    baseline (before treatment)
    Title
    Probing of depth baseline
    Description
    Measurement to the nearest millimeter from the gingival margin to the base of the clinical pocket by Williams periodontal probe
    Time Frame
    baseline (before treatment)
    Title
    Biochemical outcomes baseline
    Description
    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.
    Time Frame
    baseline (before treatment)
    Secondary Outcome Measure Information:
    Title
    Clinical attachment level after 8 weeks
    Description
    Calculation as distance in millimeters from cement-enamel junction to the bottom of the pocket by Williams periodontal probe
    Time Frame
    8 weeks after treatment
    Title
    Plaque index after 8 weeks
    Description
    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
    Time Frame
    8 weeks after treatment
    Title
    Gingival index after 8 weeks
    Description
    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
    Time Frame
    8 weeks after tretament
    Title
    Bleeding on probing after 8 weeks
    Description
    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.
    Time Frame
    8 weeks after treatment
    Title
    Probing of dept after 8 weeks
    Description
    Measurement to the nearest millimeter from the gingival margin to the base of the clinical pocket by Williams periodontal probe
    Time Frame
    8 weeks after tretament
    Title
    Biochemical outcomes after 8 weeks
    Description
    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
    Time Frame
    8 weeks after tretment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: systemically healthy non-smokers chronic periodontitis participants Exclusion Criteria: smokers pregnancy or lactation individiuals with any systemic disease

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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