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

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ClinicalTrials.gov Identifier: NCT03874390
Recruitment Status : Completed
First Posted : March 14, 2019
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Sema Nur Sevinc, Ataturk University

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

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Other: ozone Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Ozone Therapy Adjunct to Initial Periodontal Therapy on Clinical Parameters and Inflammatory Cytokines in Chronic Periodontitis Patients
Study Start Date : October 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ozone

Arm Intervention/treatment
Experimental: ozone therapy
control group only treated with Initial Periodontal Therapy (IPT), test group treated with IPT an adjunct to gasesos ozone therapy.
Other: ozone
gaseous ozone was applied on periodontal pocket two times in one week.

Active Comparator: initially periodontal therapy
control group only treated with Initial Periodontal Therapy (IPT), test group treated with IPT an adjunct to gasesos ozone therapy.
Other: ozone
gaseous ozone was applied on periodontal pocket two times in one week.




Primary Outcome Measures :
  1. Clinical atachment level baseline [ Time Frame: baseline (before treatment) ]
    Calculation as distance in millimeters from cement-enamel junction to the bottom of the pocket by Williams periodontal probe

  2. Plaque index baseline [ Time Frame: baseline (before treatment) ]

    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


  3. Gingival index baseline [ Time Frame: baseline (before treatment) ]

    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


  4. Bleeding on probing baseline [ Time Frame: baseline (before treatment) ]

    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.

  5. Probing of depth baseline [ Time Frame: baseline (before treatment) ]
    Measurement to the nearest millimeter from the gingival margin to the base of the clinical pocket by Williams periodontal probe

  6. Biochemical outcomes baseline [ Time Frame: baseline (before treatment) ]
    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 :
  1. Clinical attachment level after 8 weeks [ Time Frame: 8 weeks after treatment ]
    Calculation as distance in millimeters from cement-enamel junction to the bottom of the pocket by Williams periodontal probe

  2. Plaque index after 8 weeks [ Time Frame: 8 weeks after treatment ]

    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


  3. Gingival index after 8 weeks [ Time Frame: 8 weeks after tretament ]

    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


  4. Bleeding on probing after 8 weeks [ Time Frame: 8 weeks after treatment ]

    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.

  5. Probing of dept after 8 weeks [ Time Frame: 8 weeks after tretament ]
    Measurement to the nearest millimeter from the gingival margin to the base of the clinical pocket by Williams periodontal probe

  6. Biochemical outcomes after 8 weeks [ Time Frame: 8 weeks after tretment ]
    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



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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • systemically healthy
  • non-smokers
  • chronic periodontitis participants

Exclusion Criteria:

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

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Responsible Party: Sema Nur Sevinc, research assistant, Ataturk University
ClinicalTrials.gov Identifier: NCT03874390     History of Changes
Other Study ID Numbers: 60078
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases