- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03652558
Effects of Ozone Therapy as an Adjunct to Periodontal Treatment
August 28, 2018 updated by: Zekeriya Tasdemir, TC Erciyes University
The Effects of Ozone Therapy as an Adjunct to Periodontal Treatment: A Randomized Split-Mouth Clinical Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: ozone group
topical gaseous ozone was applied into periodontal pockets during active periodontal therapy
|
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
|
NO_INTERVENTION: non-ozone group
Only active periodontal therapy was performed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Examinations were performed at baseline and 3 months after periodontal therapy. Changes is determined with baseline values - 3 months after periodontal treatment.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gingival crevicular inflammatory parameter change
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.
|
Gingival crevicular fluid pentraxin-3 (PTX-3) ng/mL was evaluated.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 10, 2017
Primary Completion (ACTUAL)
January 10, 2018
Study Completion (ACTUAL)
February 10, 2018
Study Registration Dates
First Submitted
August 22, 2018
First Submitted That Met QC Criteria
August 28, 2018
First Posted (ACTUAL)
August 29, 2018
Study Record Updates
Last Update Posted (ACTUAL)
August 29, 2018
Last Update Submitted That Met QC Criteria
August 28, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Tasdemir
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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