Effects of Ozone Therapy as an Adjunct to Periodontal Treatment

Not Applicable

Completed

• Conditions: Periodontitis
• Interventions: Device: Ozone application with the Ozonytron XL device

• Registration Number: NCT03652558
• Lead Sponsor: TC Erciyes University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-01-10
• Primary Completion: 2018-01-10
• Study Completion: 2018-02-10
• Status Verified: 2018-08
• Study First Submitted: 2018-08-22
• Study First Submitted QC: 2018-08-28
• Last Update Submitted: 2018-08-28
• Study First Posted: 2018-08-29
• Last Update Posted: 2018-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ozone group	Ozone application with the Ozonytron XL device	topical gaseous ozone was applied into periodontal pockets during active periodontal therapy

Primary Outcome Measures

Name	Time	Method
Periodontal disease parameters change	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 Outcome Measures

Name	Time	Method
Gingival crevicular inflammatory parameter change	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.