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
About this trial
This is an interventional treatment trial for Chronic Periodontitis
Eligibility Criteria
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
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
Learn more about this trial
Effects of Ozone Therapy on Clinical Parameters and Inflammatory Cytokines in Chronic Periodontitis Patients
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