Ozone Application in Periodontal Treatment

NCT05971706 | Completed

• 1 other identifier: Ozone
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Conditions

Periodontitis

Keywords

periodontitis; ozone; treatment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• Plaque index (Silness & Löe, 1964)

  Baseline (prior to therapy)

• Plaque index (Silness & Löe, 1964)

  3rd month

• Gingival Index ( Löe & Silness,1963)

  Baseline (prior to therapy)

• Gingival Index ( Löe & Silness,1963)

  3rd month

• Bleeding on probing

  Baseline (prior to therapy)

Study Arms (2)

ozone

EXPERIMENTAL

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); Procedure: Non-surgical periodontal treatment

control

ACTIVE COMPARATOR

Only non-surgical periodontal treatment was applied

Procedure: Non-surgical periodontal treatment

Interventions

Non-surgical periodontal treatment PROCEDURE

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.

control; ozone

Ozone therapy using a device (Ozone DTA Ozone Generator, Denta Tec Dental AS, Norway) DEVICE

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.

ozone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Participants will be excluded if they had less than 20 teeth, partial dentures, or fixed prosthodontics.

Sponsors & Collaborators

• Biruni University: lead

Study Sites (1)

Biruni University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 2, 2023
• Study Start: October 27, 2023
• Primary Completion: June 15, 2024
• Study Completion: October 1, 2024
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)