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Clinical Trials/NCT03652558
NCT03652558
Completed
Not Applicable

The Effects of Ozone Therapy as an Adjunct to Periodontal Treatment: A Randomized Split-Mouth Clinical Trial

TC Erciyes University0 sites20 target enrollmentJanuary 10, 2017
ConditionsPeriodontitis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Periodontitis
Sponsor
TC Erciyes University
Enrollment
20
Primary Endpoint
Periodontal disease parameters change
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

This randomized, placebo controlled, split-mouth clinical study trial evaluates the effects of Ozone therapy on clinical and biochemical parameters. Total of 20 participants completed the study . Periodontal parameters were evaluated at baseline and 3 months following periodontal therapy. All participants were treated non-surgically. Topical gaseous ozone was applied into periodontal pockets. Gingival crevicular fluid pentraxin-3 (PTX-3), interleukin-1β (IL-1β) and high sensitivity C-reactive protein (Hs-CRP) were evaluated.

Detailed Description

Ozone therapy (OT) is very popular in medicine. Especially it use for wound healing and antibacterial properties. This randomized, placebo controlled, randomized split-mouth clinical study evaluates the effects of ozone therapy on clinical and biochemical parameters. Total of 20 participants completed the study (10 males, 10 females). Periodontal parameters, including plaque index (PI), gingival index (GI), probing depth (PD), percentage of bleeding on probing, percentage of pockets deeper than 5 mm and clinical attachment level (CAL), and percentage of ≥3 mm clinical attachment level. Periodontal parameters were evaluated at baseline and 3 months following periodontal therapy. All participants were treated non-surgically. Topical gaseous ozone was applied into periodontal pockets twice a week for 2 weeks during active periodontal therapy. Gingival crevicular fluid pentraxin-3 (PTX-3), interleukin-1β (IL-1β) and high sensitivity C-reactive protein (Hs-CRP) were evaluated.

Registry
clinicaltrials.gov
Start Date
January 10, 2017
End Date
February 10, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Zekeriya Tasdemir

Principal investigator

TC Erciyes University

Eligibility Criteria

Inclusion Criteria

  • 18 to 64 years of age
  • Generalized chronic periodontitis(Armitage, 1999)
  • Systemically healthy
  • More than 20 teeth (excluding third molars)

Exclusion Criteria

  • Periodontal treatment within 6 months
  • Antibiotic use within the previous 3 months
  • Pregnancy and lactation
  • Past or current smoking and alcohol consumption
  • Contraindications for OT
  • Patients with class II and III furcation defects(Staffileno, 1969)

Outcomes

Primary Outcomes

Periodontal disease parameters change

Time Frame: Examinations were performed at baseline and 3 months after periodontal therapy. Changes is determined with baseline values - 3 months after periodontal treatment.

Probing depth (mm) were evaluated by periodontal probe.

Secondary Outcomes

  • Gingival crevicular inflammatory parameter change(inflammatory biochemical parameters were analyzed at baseline and 3 months after periodontal therapy and changes is determined with baseline values - 3 months after periodontal therapy.)

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