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Completed

NCT Number: NCT03874390

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

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

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • systemically healthy
  • non-smokers
  • chronic periodontitis participants

Exclusion criteria

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

Treatment and study plan

Ozone

Other

gaseous ozone was applied on periodontal pocket two times in one week.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Mar 14, 2019
Registry last updated
Mar 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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