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Ozone Application in Periodontal Treatment

Primary Purpose

Periodontitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ozone therapy using a device (Ozone DTA Ozone Generator, Denta Tec Dental AS, Norway)
Non-surgical periodontal treatment
Sponsored by
Biruni University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring periodontitis, ozone, treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: systemically healthy no periodontal treatment within 6 months from the enrollment date no antibiotics or anti-inflammatory medication taken within 6 months from the enrollment date no smokers no pregnancy or lactation at the time of the stud no contraindication for periodontal treatment and ozone application Exclusion Criteria: Participants will be excluded if they had less than 20 teeth, partial dentures, or fixed prosthodontics.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    ozone

    control

    Arm Description

    Gaseous ozone was applied immediately after non-surgical periodontal treatment

    Only non-surgical periodontal treatment was applied

    Outcomes

    Primary Outcome Measures

    Probing pocket depth
    Probing pocket depth: The distance from the base of the pocket to the gingival margin. Measurements will be made at six points on all teeth (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) using a periodontal probe.
    Probing pocket depth
    robing pocket depth: The distance from the base of the pocket to the gingival margin. Measurements will be made at six points on all teeth (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) using a periodontal probe.

    Secondary Outcome Measures

    Plaque index (Silness & Löe, 1964)
    Plaque index (Silness & Löe, 1964): 0: Absence of microbial plaque Thin plaque layer at the gingival margin, only detectable by scraping with a probe Moderate layer of plaque in the along the gingival margin; interdental spaces free, but plaque is visible to naked eye Abundant plaque along with the gingival margin; interdental places filled with plaque
    Plaque index (Silness & Löe, 1964)
    Plaque index (Silness & Löe, 1964): 0: Absence of microbial plaque Thin plaque layer at the gingival margin, only detectable by scraping with a probe Moderate layer of plaque in the along the gingival margin; interdental spaces free, but plaque is visible to naked eye Abundant plaque along with the gingival margin; interdental places filled with plaque
    Gingival Index ( Löe & Silness,1963)
    0 = normal gingiva = mild inflammation - slight change in color and slight edema but no bleeding on probing = moderate inflammation - redness, edema and glazing, bleeding on probing = severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding
    Gingival Index ( Löe & Silness,1963)
    0 = normal gingiva = mild inflammation - slight change in color and slight edema but no bleeding on probing = moderate inflammation - redness, edema and glazing, bleeding on probing = severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding
    Bleeding on probing
    A bleeding-on-probing percentage score assessed as the proportion of bleeding sites (dichotomous yes/no evaluation) when stimulated by a standardized manual probe with a controlled (~25 g) force to the bottom of the sulcus/pocket at six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) on all present teeth (Ainamo & Bay 1975).
    Bleeding on probing
    A bleeding-on-probing percentage score assessed as the proportion of bleeding sites (dichotomous yes/no evaluation) when stimulated by a standardized manual probe with a controlled (~25 g) force to the bottom of the sulcus/pocket at six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) on all present teeth (Ainamo & Bay 1975).
    Proportions of bacterial species
    Subgingival plaque sampling will be performed at the 3 deepest pockets with a probing depth equal to or higher than 5mm in each treatment site with no endodontic or furcation involvement using 2 standardized sterile paper points. One will be inserted at a 45-degree angle and the other will be inserted parallel to the tooth axis and left in place for 30 seconds. Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Tannerella forsythia will be evaluated.
    Proportions of bacterial species
    Subgingival plaque sampling will be performed at the 3 deepest pockets with a probing depth equal to or higher than 5mm in each treatment site with no endodontic or furcation involvement using 2 standardized sterile paper points. One will be inserted at a 45-degree angle and the other will be inserted parallel to the tooth axis and left in place for 30 seconds. Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Tannerella forsythia will be evaluated.
    Proportions of bacterial species
    Subgingival plaque sampling will be performed at the 3 deepest pockets with a probing depth equal to or higher than 5mm in each treatment site with no endodontic or furcation involvement using 2 standardized sterile paper points. One will be inserted at a 45-degree angle and the other will be inserted parallel to the tooth axis and left in place for 30 seconds. Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Tannerella forsythia will be evaluated.
    Inflammatory parameter levels in gingival crevicular fluid
    Subgingival plaque sampling will be performed at the 3 deepest pockets with a probing depth equal to or higher than 5mm in each treatment site with no endodontic or furcation involvement using sterile paper strips. Gingival crevicular fluid Tumor necrotizing factor-alpha, interleukin-1beta, interleukin-6, interleukin-8 levels will be evaluated.
    Inflammatory parameter levels in gingival crevicular fluid
    Subgingival plaque sampling will be performed at the 3 deepest pockets with a probing depth equal to or higher than 5mm in each treatment site with no endodontic or furcation involvement using sterile paper strips. Gingival crevicular fluid Tumor necrotizing factor-alpha, interleukin-1beta, interleukin-6, interleukin-8 levels will be evaluated.
    Inflammatory parameter levels in gingival crevicular fluid
    Subgingival plaque sampling will be performed at the 3 deepest pockets with a probing depth equal to or higher than 5mm in each treatment site with no endodontic or furcation involvement using sterile paper strips. Gingival crevicular fluid Tumor necrotizing factor-alpha, interleukin-1beta, interleukin-6, interleukin-8 levels will be evaluated.

    Full Information

    First Posted
    July 25, 2023
    Last Updated
    August 1, 2023
    Sponsor
    Biruni University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05971706
    Brief Title
    Ozone Application in Periodontal Treatment
    Official Title
    Impact of Ozone Application in Periodontitis Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 25, 2023 (Anticipated)
    Primary Completion Date
    August 15, 2024 (Anticipated)
    Study Completion Date
    November 15, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Biruni University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This clinical trial aims to evaluate the clinical, biochemical and microbiological efficacy of ozone treatment as an adjunct to nonsurgical periodontal treatment (NSPT) in periodontitis patients. The main question it aims to answer is: • Is the application of gaseous ozone, as an adjunct to NSPT, to periodontal pockets in patients with periodontitis alters the clinical periodontal parameters, gingival crevicular fluid levels of inflammatory cytokines, and periodontal pathogens compared to NSPT alone? The study will be performed according to a split-mouth design, the contralateral quadrants with similar periodontal status in each patient will be randomly allocated to one of the following two different treatment modalities. Participants will be applied NSPT consisting of supra and subgingival debridement. NSPT will be applied alone in one quadrant In addition to NSPT, ozone therapy procedures were performed using a device at contralateral sites. Researchers will compare the sites with and without ozone therapy in addition to NSPT to see if ozone therapy adjunct to the NSPT affects clinical, biochemical, and microbiological changes

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontitis
    Keywords
    periodontitis, ozone, treatment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    18 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ozone
    Arm Type
    Experimental
    Arm Description
    Gaseous ozone was applied immediately after non-surgical periodontal treatment
    Arm Title
    control
    Arm Type
    Active Comparator
    Arm Description
    Only non-surgical periodontal treatment was applied
    Intervention Type
    Device
    Intervention Name(s)
    Ozone therapy using a device (Ozone DTA Ozone Generator, Denta Tec Dental AS, Norway)
    Intervention Description
    Ozone therapy procedures will be performed immediately after non-surgical periodontal treatment and three times (every third day) within one week using a device equipped with a periodontal tip according to equipment producer recommendations. The periodontal tip will be halted 1 mm short of the pocket depth. Ozone will be applied only to the pockets; which depth is equal to or greater than 5 mm. Ozone application time to the pockets will be 30 seconds at a fixed concentration of 2,100 ppm (80% oxygen) through a connected handpiece.
    Intervention Type
    Procedure
    Intervention Name(s)
    Non-surgical periodontal treatment
    Intervention Description
    Non-surgical periodontal treatment consists of oral hygiene instructions, full mouth supragingival scaling using hand instruments, ultrasonic devices, polishing, and subgingival debridement under local anesthesia with sharp Gracey and Universal curettes and ultrasonic instruments in a single appointment.
    Primary Outcome Measure Information:
    Title
    Probing pocket depth
    Description
    Probing pocket depth: The distance from the base of the pocket to the gingival margin. Measurements will be made at six points on all teeth (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) using a periodontal probe.
    Time Frame
    Baseline (prior to therapy)
    Title
    Probing pocket depth
    Description
    robing pocket depth: The distance from the base of the pocket to the gingival margin. Measurements will be made at six points on all teeth (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) using a periodontal probe.
    Time Frame
    3rd month after treatment
    Secondary Outcome Measure Information:
    Title
    Plaque index (Silness & Löe, 1964)
    Description
    Plaque index (Silness & Löe, 1964): 0: Absence of microbial plaque Thin plaque layer at the gingival margin, only detectable by scraping with a probe Moderate layer of plaque in the along the gingival margin; interdental spaces free, but plaque is visible to naked eye Abundant plaque along with the gingival margin; interdental places filled with plaque
    Time Frame
    Baseline (prior to therapy)
    Title
    Plaque index (Silness & Löe, 1964)
    Description
    Plaque index (Silness & Löe, 1964): 0: Absence of microbial plaque Thin plaque layer at the gingival margin, only detectable by scraping with a probe Moderate layer of plaque in the along the gingival margin; interdental spaces free, but plaque is visible to naked eye Abundant plaque along with the gingival margin; interdental places filled with plaque
    Time Frame
    3rd month
    Title
    Gingival Index ( Löe & Silness,1963)
    Description
    0 = normal gingiva = mild inflammation - slight change in color and slight edema but no bleeding on probing = moderate inflammation - redness, edema and glazing, bleeding on probing = severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding
    Time Frame
    Baseline (prior to therapy)
    Title
    Gingival Index ( Löe & Silness,1963)
    Description
    0 = normal gingiva = mild inflammation - slight change in color and slight edema but no bleeding on probing = moderate inflammation - redness, edema and glazing, bleeding on probing = severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding
    Time Frame
    3rd month
    Title
    Bleeding on probing
    Description
    A bleeding-on-probing percentage score assessed as the proportion of bleeding sites (dichotomous yes/no evaluation) when stimulated by a standardized manual probe with a controlled (~25 g) force to the bottom of the sulcus/pocket at six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) on all present teeth (Ainamo & Bay 1975).
    Time Frame
    Baseline (prior to therapy)
    Title
    Bleeding on probing
    Description
    A bleeding-on-probing percentage score assessed as the proportion of bleeding sites (dichotomous yes/no evaluation) when stimulated by a standardized manual probe with a controlled (~25 g) force to the bottom of the sulcus/pocket at six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) on all present teeth (Ainamo & Bay 1975).
    Time Frame
    3rd month
    Title
    Proportions of bacterial species
    Description
    Subgingival plaque sampling will be performed at the 3 deepest pockets with a probing depth equal to or higher than 5mm in each treatment site with no endodontic or furcation involvement using 2 standardized sterile paper points. One will be inserted at a 45-degree angle and the other will be inserted parallel to the tooth axis and left in place for 30 seconds. Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Tannerella forsythia will be evaluated.
    Time Frame
    Baseline (prior to therapy)
    Title
    Proportions of bacterial species
    Description
    Subgingival plaque sampling will be performed at the 3 deepest pockets with a probing depth equal to or higher than 5mm in each treatment site with no endodontic or furcation involvement using 2 standardized sterile paper points. One will be inserted at a 45-degree angle and the other will be inserted parallel to the tooth axis and left in place for 30 seconds. Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Tannerella forsythia will be evaluated.
    Time Frame
    1st month
    Title
    Proportions of bacterial species
    Description
    Subgingival plaque sampling will be performed at the 3 deepest pockets with a probing depth equal to or higher than 5mm in each treatment site with no endodontic or furcation involvement using 2 standardized sterile paper points. One will be inserted at a 45-degree angle and the other will be inserted parallel to the tooth axis and left in place for 30 seconds. Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Tannerella forsythia will be evaluated.
    Time Frame
    3rd month
    Title
    Inflammatory parameter levels in gingival crevicular fluid
    Description
    Subgingival plaque sampling will be performed at the 3 deepest pockets with a probing depth equal to or higher than 5mm in each treatment site with no endodontic or furcation involvement using sterile paper strips. Gingival crevicular fluid Tumor necrotizing factor-alpha, interleukin-1beta, interleukin-6, interleukin-8 levels will be evaluated.
    Time Frame
    Baseline (prior to therapy)
    Title
    Inflammatory parameter levels in gingival crevicular fluid
    Description
    Subgingival plaque sampling will be performed at the 3 deepest pockets with a probing depth equal to or higher than 5mm in each treatment site with no endodontic or furcation involvement using sterile paper strips. Gingival crevicular fluid Tumor necrotizing factor-alpha, interleukin-1beta, interleukin-6, interleukin-8 levels will be evaluated.
    Time Frame
    1st month
    Title
    Inflammatory parameter levels in gingival crevicular fluid
    Description
    Subgingival plaque sampling will be performed at the 3 deepest pockets with a probing depth equal to or higher than 5mm in each treatment site with no endodontic or furcation involvement using sterile paper strips. Gingival crevicular fluid Tumor necrotizing factor-alpha, interleukin-1beta, interleukin-6, interleukin-8 levels will be evaluated.
    Time Frame
    3rd month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: systemically healthy no periodontal treatment within 6 months from the enrollment date no antibiotics or anti-inflammatory medication taken within 6 months from the enrollment date no smokers no pregnancy or lactation at the time of the stud no contraindication for periodontal treatment and ozone application Exclusion Criteria: Participants will be excluded if they had less than 20 teeth, partial dentures, or fixed prosthodontics.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Burcu Karaduman, Professor
    Phone
    +905323763366
    Email
    bkaraduman@biruni.edu.tr

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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