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
About this trial
This is an interventional treatment trial for Periodontitis focused on measuring periodontitis, ozone, treatment
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.
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
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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Ozone Application in Periodontal Treatment
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