search
Back to results

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
TC Erciyes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    August 22, 2018
    Last Updated
    August 28, 2018
    Sponsor
    TC Erciyes University
    search

    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

    Learn more about this trial

    Effects of Ozone Therapy as an Adjunct to Periodontal Treatment

    We'll reach out to this number within 24 hrs