Ozone Application in Periodontal Treatment

Not Applicable

Recruiting

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

• Registration Number: NCT05971706
• Lead Sponsor: Biruni University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-25
• Study First Submitted QC: 2023-08-01
• Study First Posted: 2023-08-02
• Study Start: 2023-09-27
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-05
• Last Update Posted: 2023-12-12
• Primary Completion: 2024-08-15
• Study Completion: 2025-11-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ozone	Ozone therapy using a device (Ozone DTA Ozone Generator, Denta Tec Dental AS, Norway)	Gaseous ozone was applied immediately after non-surgical periodontal treatment
ozone	Non-surgical periodontal treatment	Gaseous ozone was applied immediately after non-surgical periodontal treatment
control	Non-surgical periodontal treatment	Only non-surgical periodontal treatment was applied

Primary Outcome Measures

Name	Time	Method
Probing pocket depth	3rd month after treatment	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

Name	Time	Method
Plaque index (Silness & Löe, 1964)	3rd month	Plaque index (Silness \& Löe, 1964): 0: Absence of microbial plaque; 1. Thin plaque layer at the gingival margin, only detectable by scraping with a probe; 2. Moderate layer of plaque in the along the gingival margin; interdental spaces free, but plaque is visible to naked eye; 3. Abundant plaque along with the gingival margin; interdental places filled with plaque
Gingival Index ( Löe & Silness,1963)	3rd month	0 = normal gingiva; 1. = mild inflammation - slight change in color and slight edema but no bleeding on probing; 2. = moderate inflammation - redness, edema and glazing, bleeding on probing; 3. = severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding
Bleeding on probing	3rd month	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).
Inflammatory parameter levels in gingival crevicular fluid	3rd month	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.
Proportions of bacterial species	3rd month	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.

Trial Locations

Locations (1)

Biruni University; 🇹🇷 Istanbul, Turkey