Ozone Application in Periodontal Treatment

Periodontitis Clinical Trial

Official title:

Impact of Ozone Application in Periodontitis Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05971706
• Other study ID #: Ozone
• Status: Recruiting
• Phase: N/A
• Start date: September 27, 2023
• Est. completion date: November 15, 2025

Study information

• Verified date: December 2023
• Source: Biruni University
• Contact: Burcu Karaduman, Professor
• Phone: +905323763366
• Email: bkaraduman[@]biruni.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: November 15, 2025
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Periodontitis

Intervention

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.

Locations

Country	Name	City	State
Turkey	Biruni University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Biruni University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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