Effects of Ozone Therapy as an Adjunct to Periodontal Treatment

This randomized, placebo controlled, split-mouth clinical study trial evaluates the effects of Ozone therapy on clinical and biochemical parameters. Total of 20 participants completed the study . Periodontal parameters were evaluated at baseline and 3 months following periodontal therapy. All participants were treated non-surgically. Topical gaseous ozone was applied into periodontal pockets. Gingival crevicular fluid pentraxin-3 (PTX-3), interleukin-1β (IL-1β) and high sensitivity C-reactive protein (Hs-CRP) were evaluated.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Ozone therapy (OT) is very popular in medicine. Especially it use for wound healing and antibacterial properties. This randomized, placebo controlled, randomized split-mouth clinical study evaluates the effects of ozone therapy on clinical and biochemical parameters. Total of 20 participants completed the study (10 males, 10 females). Periodontal parameters, including plaque index (PI), gingival index (GI), probing depth (PD), percentage of bleeding on probing, percentage of pockets deeper than 5 mm and clinical attachment level (CAL), and percentage of ≥3 mm clinical attachment level. Periodontal parameters were evaluated at baseline and 3 months following periodontal therapy. All participants were treated non-surgically. Topical gaseous ozone was applied into periodontal pockets twice a week for 2 weeks during active periodontal therapy. Gingival crevicular fluid pentraxin-3 (PTX-3), interleukin-1β (IL-1β) and high sensitivity C-reactive protein (Hs-CRP) were evaluated.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

18 to 64 years of age
Generalized chronic periodontitis(Armitage, 1999)
Systemically healthy
More than 20 teeth (excluding third molars)

Exclusion criteria

Periodontal treatment within 6 months
Antibiotic use within the previous 3 months
Pregnancy and lactation
Past or current smoking and alcohol consumption
Contraindications for OT
Patients with class II and III furcation defects(Staffileno, 1969)

Treatment and study plan

Ozone application with the Ozonytron XL device

Device

An ozone generator (Ozonytron; Bionix, Munchen, Germany) with an KPX probe (CA Probe; Ozonytron, Bionix, Munchen, Germany) was used for OT. Topical gaseous ozone was applied into the periodontal pocket twice a week for 2 weeks based on the manufacturer's instructions. Ozone applications were at 75% power for 30 seconds (75 µg/ml). Ozone applications were performed by an experienced investigator. Ozone applications in the control side were simulated without starting the ozone generator

Primary outcomes

Periodontal disease parameters change

Time frame: Examinations were performed at baseline and 3 months after periodontal therapy. Changes is determined with baseline values - 3 months after periodontal treatment.

Probing depth (mm) were evaluated by periodontal probe.

Secondary outcomes

Gingival crevicular inflammatory parameter change

Time frame: inflammatory biochemical parameters were analyzed at baseline and 3 months after periodontal therapy and changes is determined with baseline values - 3 months after periodontal therapy.

Gingival crevicular fluid pentraxin-3 (PTX-3) ng/mL was evaluated.

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

The Effects of Ozone Therapy as an Adjunct to Periodontal Treatment: A Randomized Split-Mouth Clinical Trial

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Aug 29, 2018
Registry last updated: Aug 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed