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临床试验/NCT03874390
NCT03874390已完成不适用

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

Ataturk University0 个研究点目标入组 50 人开始时间: 2014年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
主要终点
Clinical atachment level baseline

研究概览

简要总结

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

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • systemically healthy
  • non-smokers
  • chronic periodontitis participants

排除标准

  • pregnancy or lactation
  • individiuals with any systemic disease

研究组 & 干预措施

ozone therapy

Experimental

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

干预措施: ozone (Other)

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.

干预措施: ozone (Other)

结局指标

主要结局

Clinical atachment level baseline

时间窗: baseline (before treatment)

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

Probing of depth baseline

时间窗: 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

时间窗: 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.

Plaque index baseline

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • Bleeding on probing after 8 weeks(8 weeks after treatment)
  • Clinical attachment level after 8 weeks(8 weeks after treatment)
  • Gingival index after 8 weeks(8 weeks after tretament)
  • Biochemical outcomes after 8 weeks(8 weeks after tretment)
  • Plaque index after 8 weeks(8 weeks after treatment)
  • Probing of dept after 8 weeks(8 weeks after tretament)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sema Nur Sevinc

research assistant

Ataturk University

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