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

Overview

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

Full Title of Study: “Effects of Ozone Therapy Adjunct to Initial Periodontal Therapy on Clinical Parameters and Inflammatory Cytokines in Chronic Periodontitis Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: October 2015

Detailed Description

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

Interventions

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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • 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
  • 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
  • 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.
  • 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
  • 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 Measures

  • 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
  • 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
  • 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
  • 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.
  • 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
  • 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

Participating in This Clinical Trial

Inclusion Criteria

  • systemically healthy – non-smokers – chronic periodontitis participants Exclusion Criteria:

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

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ataturk University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sema Nur Sevinc, research assistant – Ataturk University

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