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

NCT03874390 | Completed DMC

• 1 other identifier: 60078
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (6)

• Clinical atachment level baseline

  Calculation as distance in millimeters from cement-enamel junction to the bottom of the pocket by Williams periodontal probe

  baseline (before treatment)

• 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

  baseline (before treatment)

• 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

  baseline (before treatment)

• 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.

  baseline (before treatment)

• Probing of depth baseline

  Measurement to the nearest millimeter from the gingival margin to the base of the clinical pocket by Williams periodontal probe

  baseline (before treatment)

• 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.

  baseline (before treatment)

Secondary Outcomes (6)

• Clinical attachment level after 8 weeks

  8 weeks after treatment

• Plaque index after 8 weeks

  8 weeks after treatment

• Gingival index after 8 weeks

  8 weeks after tretament

• Bleeding on probing after 8 weeks

  8 weeks after treatment

• Probing of dept after 8 weeks

  8 weeks after tretament

Study Arms (2)

ozone therapy

EXPERIMENTAL

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

Other: ozone

initially periodontal therapy

ACTIVE COMPARATOR

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

Other: ozone

Interventions

ozone OTHER

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

initially periodontal therapy; ozone therapy

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• systemically healthy
• non-smokers
• chronic periodontitis participants

You may not qualify if:

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

Sponsors & Collaborators

• Ataturk University: lead

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Ozone

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oxygen; Gases; Inorganic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Study Record Dates

• First Submitted: May 1, 2016
• First Posted: March 14, 2019
• Study Start: October 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: February 1, 2016
• Last Updated: March 15, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share