Effects of Ozone Therapy as an Adjunct to Periodontal Treatment

NCT ID: NCT03652558

Last Updated: 2018-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-10
• Study Completion Date: 2018-02-10

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.

Conditions

Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ozone group

topical gaseous ozone was applied into periodontal pockets during active periodontal therapy

Group Type: EXPERIMENTAL

Ozone application with the Ozonytron XL device

Intervention Type: 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

non-ozone group

Only active periodontal therapy was performed

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ozone application with the Ozonytron XL 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

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

TC Erciyes University

OTHER

Sponsor Role: lead

Responsible Party

Zekeriya Tasdemir

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zekeriya Taşdemir, Phd

Role: PRINCIPAL_INVESTIGATOR

TC Erciyes University

Other Identifiers

Tasdemir

Identifier Type: -

Identifier Source: org_study_id