Ozone Application in Periodontal Treatment

Impact of Ozone Application in Periodontitis Patients

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

Study Overview

• Status: Recruiting
• Conditions: Periodontitis
• Intervention / Treatment: Device: Ozone therapy using a device (Ozone DTA Ozone Generator, Denta Tec Dental AS, Norway); Procedure: Non-surgical periodontal treatment

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Burcu Karaduman, Professor; Phone Number: +905323763366; Email: bkaraduman@biruni.edu.tr

Study Locations

• Turkey
  • Istanbul, Turkey
    • Recruiting
    • Biruni University
    • Contact: Burcu Karaduman; Phone Number: +90212 444 83 76; Email: bkaraduman@biruni.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ozone; Gaseous ozone was applied immediately after non-surgical periodontal treatment	Device: Ozone therapy using a device (Ozone DTA Ozone Generator, Denta Tec Dental AS, Norway); 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.; Procedure: Non-surgical periodontal treatment; 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.
Active Comparator: control; Only non-surgical periodontal treatment was applied	Procedure: Non-surgical periodontal treatment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (prior to therapy)
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.	3rd month after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline (prior to therapy)
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	3rd month
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	Baseline (prior to therapy)
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	3rd month
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).	Baseline (prior to therapy)
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).	3rd month
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.	Baseline (prior to therapy)
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.	1st month
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.	3rd month
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.	Baseline (prior to therapy)
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.	1st month
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.	3rd month

Collaborators and Investigators

• Sponsor: Biruni University

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2023
• Primary Completion (Estimated): August 15, 2024
• Study Completion (Estimated): November 15, 2025

Study Registration Dates

• First Submitted: July 25, 2023
• First Submitted That Met QC Criteria: August 1, 2023
• First Posted (Actual): August 2, 2023

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: treatment; periodontitis; ozone
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: Ozone

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No