Effects of Ozone Therapy as an Adjunct to Periodontal Treatment
Primary Purpose
Periodontitis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ozone application with the Ozonytron XL device
Sponsored by

About this trial
This is an interventional treatment trial for Periodontitis
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
ozone group
non-ozone group
Arm Description
topical gaseous ozone was applied into periodontal pockets during active periodontal therapy
Only active periodontal therapy was performed
Outcomes
Primary Outcome Measures
Periodontal disease parameters change
Probing depth (mm) were evaluated by periodontal probe.
Secondary Outcome Measures
Gingival crevicular inflammatory parameter change
Gingival crevicular fluid pentraxin-3 (PTX-3) ng/mL was evaluated.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03652558
Brief Title
Effects of Ozone Therapy as an Adjunct to Periodontal Treatment
Official Title
The Effects of Ozone Therapy as an Adjunct to Periodontal Treatment: A Randomized Split-Mouth Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 10, 2017 (Actual)
Primary Completion Date
January 10, 2018 (Actual)
Study Completion Date
February 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TC Erciyes University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
In this study the investigators select the split mouth study design to eleminate host effects on healing.
Masking
ParticipantInvestigator
Masking Description
Investigators who evaluate the clinical and biochemical parameters did no know the groups.
And participants did not know ozone device work or not when holding the probe.
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ozone group
Arm Type
Experimental
Arm Description
topical gaseous ozone was applied into periodontal pockets during active periodontal therapy
Arm Title
non-ozone group
Arm Type
No Intervention
Arm Description
Only active periodontal therapy was performed
Intervention Type
Device
Intervention Name(s)
Ozone application with the Ozonytron XL device
Intervention Description
An ozone generator (Ozonytron; Bionix, Munchen, Germany) with an KPX probe (CA Probe; Ozonytron, Bionix, Munchen, Germany) was used for OT. Topical gaseous ozone was applied into the periodontal pocket twice a week for 2 weeks based on the manufacturer's instructions. Ozone applications were at 75% power for 30 seconds (75 µg/ml). Ozone applications were performed by an experienced investigator. Ozone applications in the control side were simulated without starting the ozone generator
Primary Outcome Measure Information:
Title
Periodontal disease parameters change
Description
Probing depth (mm) were evaluated by periodontal probe.
Time Frame
Examinations were performed at baseline and 3 months after periodontal therapy. Changes is determined with baseline values - 3 months after periodontal treatment.
Secondary Outcome Measure Information:
Title
Gingival crevicular inflammatory parameter change
Description
Gingival crevicular fluid pentraxin-3 (PTX-3) ng/mL was evaluated.
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zekeriya Taşdemir, Phd
Organizational Affiliation
TC Erciyes University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effects of Ozone Therapy as an Adjunct to Periodontal Treatment
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